Comparing In-Person to Videoconference-Based Cognitive Behavioral Therapy for Mood and Anxiety Disorders: Randomized Controlled Trial

Background

Cognitive-behavioral therapy (CBT) has demonstrated efficacy and effectiveness for treating mood and anxiety disorders. Dissemination of CBT via videoconference may help improve access to treatment.

Objective

The present study aimed to compare the effectiveness of CBT administered via videoconference to in-person therapy for a mixed diagnostic cohort.

Methods

A total of 26 primarily Caucasian clients (mean age 30 years, SD 11) who had a primary Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) diagnosis of a mood or anxiety disorder were randomly assigned to receive 12 sessions of CBT either in-person or via videoconference. Treatment involved individualized CBT formulations specific to the presenting diagnosis; all sessions were provided by the same therapist. Participants were recruited through a university clinic. Symptoms of depression, anxiety, stress, and quality of life were assessed using questionnaires before, after, and 6 weeks following treatment. Secondary outcomes at posttreatment included working alliance and client satisfaction.

Results

Retention was similar across treatment conditions; there was one more client in the videoconferencing condition at posttreatment and at follow-up. Statistical analysis using multilevel mixed effects linear regression indicated a significant reduction in client symptoms across time for symptoms of depression (P<.001, d=1.41), anxiety (P<.001, d=1.14), stress (P<.001, d=1.81), and quality of life (P<.001, d=1.17). There were no significant differences between treatment conditions regarding symptoms of depression (P=.165, d=0.37), anxiety (P=.41, d=0.22), stress (P=.15, d=0.38), or quality of life (P=.62, d=0.13). There were no significant differences in client rating of the working alliance (P=.53, one-tailed, d=–0.26), therapist ratings of the working alliance (P=.60, one-tailed, d=0.23), or client ratings of satisfaction (P=.77, one-tailed, d=–0.12). Fisher’s Exact P was not significant regarding differences in reliable change from pre- to posttreatment or from pretreatment to follow-up for symptoms of depression (P=.41, P=.26), anxiety (P=.60, P=.99), or quality of life (P=.65, P=.99) but was significant for symptoms of stress in favor of the videoconferencing condition (P=.03, P=.035). Difference between conditions regarding clinically significant change was also not observed from pre- to posttreatment or from pretreatment to follow-up for symptoms of depression (P=.67, P=.30), anxiety (P=.99, P=.99), stress (P=.19, P=.13), or quality of life (P=.99, P=.62).

Conclusions

The findings of this controlled trial indicate that CBT was effective in significantly reducing symptoms of depression, anxiety, and stress and increasing quality of life in both in-person and videoconferencing conditions, with no significant differences being observed between the two.

Trial Registration

Australian New Zealand Clinical Trials Registry ID: ACTRN12609000819224; http://www.anzctr.org.au/ACTRN12609000819224.aspx (Archived by WebCite at http://www.webcitation.org/6Kz5iBMiV).     

Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial

BackgroundHeart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients’ compliance with self-care, although the results are still contradictory.ObjectiveA randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization.MethodsHF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients’ clinical status, use of health care resources, adherence, and user experience from the patients’ and the health care professionals’ perspective were studied.ResultsAdherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients’ clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study.ConclusionsHome telemonitoring did not reduce the number of patients’ HF-related hospital days and did not improve the patients’ clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01759368","term_id":"NCT01759368"}}NCT01759368; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01759368","term_id":"NCT01759368"}}NCT01759368 (Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z).     

Health Coaching Reduces HbA1c in Type 2 Diabetic Patients From a Lower-Socioeconomic Status Community: A Randomized Controlled Trial

BackgroundAdoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus (T2DM) diagnoses. However, adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging, especially for people living in lower-socioeconomic status (SES) communities. Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems.ObjectiveTo evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes.MethodsIn this noninferiority, pragmatic randomized controlled trial (RCT), patients from two primary care health centers in Toronto, Canada, with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c (HbA1c) level of ≥7.3% (56.3 mmol/mol) were randomized to receive 6 months of health coaching with or without mobile phone monitoring support. We hypothesized that both approaches would result in significant HbA1c reductions, although health coaching with mobile phone monitoring would result in significantly larger effects. Participants were evaluated at baseline, 3 months, and 6 months. The primary outcome was the change in HbA1c from baseline to 6 months (difference between and within groups). Other outcomes included weight, waist circumference, body mass index (BMI), satisfaction with life, depression and anxiety (Hospital Anxiety and Depression Scale [HADS]), positive and negative affect (Positive and Negative Affect Schedule [PANAS]), and quality of life (Short Form Health Survey-12 [SF-12]).ResultsA total of 138 patients were randomized and 7 were excluded for a substudy; of the remaining 131, 67 were allocated to the intervention group and 64 to the control group. Primary outcome data were available for 97 participants (74.0%). While both groups reduced their HbA1c levels, there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat (last observation carried forward [LOCF]) (P=.48) or per-protocol (P=.83) principles. However, the intervention group did achieve an accelerated HbA1c reduction, leading to a significant between-group difference at 3 months (P=.03). This difference was reduced at the 6-month follow-up as the control group continued to improve, achieving a reduction of 0.81% (8.9 mmol/mol) (P=.001) compared with a reduction of 0.84% (9.2 mmol/mol)(P=.001) in the intervention group. Intervention group participants also had significant decreases in weight (P=.006) and waist circumference (P=.01) while controls did not. Both groups reported improvements in mood, satisfaction with life, and quality of life.ConclusionsHealth coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES, T2DM population. The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program. Overall, health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02036892","term_id":"NCT02036892"}}NCT02036892; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02036892","term_id":"NCT02036892"}}NCT02036892 (Archived by WebCite at http://www.webcitation.org/6b3cJYJOD)     

An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

BackgroundDepression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain.ObjectiveOur aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression.MethodsMulticenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken.ResultsThere was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings.ConclusionsAn Internet-based intervention for depression combined with iTAU conferred a benefit over iTAU alone in the Spanish primary health care system.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01611818","term_id":"NCT01611818"}}NCT01611818; https://register.clinicaltrials.gov/prs/app/action/SelectProtocol? selectaction=Edit&uid=U0001NPQ&ts=2&cx=gctdh2&sid=S0003KJ6 (Archived by WebCite at http://www.webcitation.org/6jbsUvUDz)     

Using Videogame Apps to Assess Gains in Adolescents’ Substance Use Knowledge: New Opportunities for Evaluating Intervention Exposure and Content Mastery

BackgroundVideogame interventions are becoming increasingly popular as a means to engage people in behavioral interventions; however, strategies for examining data from such interventions have not been developed.ObjectiveThe objective of this study was to describe how a technology-based intervention can yield meaningful, objective evidence of intervention exposure within a behavioral intervention. This study demonstrates the analysis of automatic log files, created by software from a videogame intervention, that catalog game play and, as proof of concept, the association of these data with changes in substance use knowledge as documented with standardized assessments.MethodsWe analyzed 3- and 6-month follow-up data from 166 participants enrolled in a randomized controlled trial evaluating a videogame intervention, PlayForward: Elm City Stories (PlayForward). PlayForward is a videogame developed as a risk reduction and prevention program targeting HIV risk behaviors (substance use and sex) in young minority adolescents. Log files were analyzed to extract the total amount of time spent playing the videogame intervention and the total number of game levels completed and beaten by each player.ResultsCompleting and beating more of the game levels, and not total game play time, was related to higher substance use knowledge scores at the 3- (P=.001) and 6-month (P=.001) follow-ups.ConclusionsOur findings highlight the potential contributions a videogame intervention can make to the study of health behavior change. Specifically, the use of objective data collected during game play can address challenges in traditional human-delivered behavioral interventions.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01666496","term_id":"NCT01666496"}}NCT01666496; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01666496","term_id":"NCT01666496"}}NCT01666496 (Archived by WebCite at http://www.webcitation.org/6cV9fxsOg)     

A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial

Background

Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers’ needs for information about the patient’s status or how the caregiver can help.

Objective

We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach.

Methods

We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a “CarePartner” outside their household. Patients randomized to “standard mHealth” (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients’ responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to “mHealth+CP” (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient’s status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments.

Results

Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05). Among patients with more depressive symptoms at enrollment, those randomized to mHealth+CP were more likely than standard mHealth patients to report excellent or very good general health during weekly IVR calls.

Conclusions

Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients’ medication adherence and caregiver communication. mHealth+CP may also decrease patients’ risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms. Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical, infrequent retrospective surveys.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00555360","term_id":"NCT00555360"}}NCT00555360; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00555360","term_id":"NCT00555360"}}NCT00555360 (Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B).     

Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

BackgroundType 2 diabetes mellitus is a worldwide challenge. Practice guidelines promote structured self-monitoring of blood glucose (SMBG) for informing health care providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change. Paired glucose testing—pairs of glucose results obtained before and after a meal or physical activity—is a method of structured SMBG. However, frequent access to glucose data to interpret values and recommend actions is challenging. A complete feedback loop—data collection and interpretation combined with feedback to modify treatment—has been associated with improved outcomes, yet there remains limited integration of SMBG feedback in diabetes management. Incorporating telehealth remote monitoring and asynchronous electronic health record (EHR) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management—employ the complete feedback loop to improve outcomes.ObjectiveThe purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A_1c)—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test.MethodsA 2-group randomized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits. Participants were aged 30-70 years, not using insulin with A_1c levels between 7.5% and 10.9% (58-96 mmol/mol). The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly. CDEs called participants monthly to discuss paired glucose testing trends and treatment changes. Separate mixed-effects models were used to analyze data.ResultsParticipants (N=90) were primarily white (64%, 56/87), mean age 58 (SD 11) years, mean body mass index 34.1 (SD 6.7) kg/m2, with diabetes for mean 8.2 (SD 5.4) years, and a mean A_1c of 8.3% (SD 1.1; 67 mmol/mol). Both groups lowered A_1c with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months (SE 0.08, t₁₅₉=–2.87, P=.005). Change in medication (SE 0.21, t₁₅₇=–3.37, P=.009) was significantly associated with lower A_1c level. The treatment group significantly improved on the SDSCA subscales carbohydrate spacing (P=.04), monitoring glucose (P=.001), and foot care (P=.02).ConclusionsAn eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A_1c levels compared to usual care.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01715649","term_id":"NCT01715649"}}NCT01715649; https://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01715649","term_id":"NCT01715649"}}NCT01715649 (Archived by WebCite at http://www.webcitation.org/6ZinLl8D0).     

Effects of a Web-Based Personalized Intervention on Physical Activity in European Adults: A Randomized Controlled Trial

BackgroundThe high prevalence of physical inactivity worldwide calls for innovative and more effective ways to promote physical activity (PA). There are limited objective data on the effectiveness of Web-based personalized feedback on increasing PA in adults.ObjectiveIt is hypothesized that providing personalized advice based on PA measured objectively alongside diet, phenotype, or genotype information would lead to larger and more sustained changes in PA, compared with nonpersonalized advice.MethodsA total of 1607 adults in seven European countries were randomized to either a control group (nonpersonalized advice, Level 0, L0) or to one of three personalized groups receiving personalized advice via the Internet based on current PA plus diet (Level 1, L1), PA plus diet and phenotype (Level 2, L2), or PA plus diet, phenotype, and genotype (Level 3, L3). PA was measured for 6 months using triaxial accelerometers, and self-reported using the Baecke questionnaire. Outcomes were objective and self-reported PA after 3 and 6 months.ResultsWhile 1270 participants (85.81% of 1480 actual starters) completed the 6-month trial, 1233 (83.31%) self-reported PA at both baseline and month 6, but only 730 (49.32%) had sufficient objective PA data at both time points. For the total cohort after 6 months, a greater improvement in self-reported total PA (P=.02) and PA during leisure (nonsport) (P=.03) was observed in personalized groups compared with the control group. For individuals advised to increase PA, we also observed greater improvements in those two self-reported indices (P=.006 and P=.008, respectively) with increased personalization of the advice (L2 and L3 vs L1). However, there were no significant differences in accelerometer results between personalized and control groups, and no significant effect of adding phenotypic or genotypic information to the tailored feedback at month 3 or 6. After 6 months, there were small but significant improvements in the objectively measured physical activity level (P<.05), moderate PA (P<.01), and sedentary time (P<.001) for individuals advised to increase PA, but these changes were similar across all groups.ConclusionsDifferent levels of personalization produced similar small changes in objective PA. We found no evidence that personalized advice is more effective than conventional “one size fits all” guidelines to promote changes in PA in our Web-based intervention when PA was measured objectively. Based on self-reports, PA increased to a greater extent with more personalized advice. Thus, it is crucial to measure PA objectively in any PA intervention study.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01530139","term_id":"NCT01530139"}}NCT01530139; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01530139","term_id":"NCT01530139"}}NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz)     

A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

Background

Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact.

Objective

This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration.

Methods

A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes).

Results

At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P<.001), and less comfort with other men’s inappropriate behaviors (P<.001).

Conclusions

Our results support the efficacy of RealConsent. Due to its Web-based format, RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence.

Trial Registration

Clinicaltrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01903876","term_id":"NCT01903876"}}NCT01903876; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01903876","term_id":"NCT01903876"}}NCT01903876 (Archived by WebCite at http://www.webcitation.org/6S1PXxWKt).     

A Text Messaging-Based Smoking Cessation Program for Adult Smokers: Randomized Controlled Trial

BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content “paths” based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ² ₁=1.4, P=.24; R²=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ² ₁=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ² ₁=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ² ₁=0.12, P=.73), or missing 5 or more program messages (χ² ₁=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00912795","term_id":"NCT00912795"}}NCT00912795 http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00912795","term_id":"NCT00912795"}}NCT00912795 (Archived by WebCite at http://www.webcitation.org/6Ch1cIA8l).     

Telemonitoring and Mobile Phone-Based Health Coaching Among Finnish Diabetic and Heart Disease Patients: Randomized Controlled Trial

Background

There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases.

Objective

The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program, which was supported by a remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or the clinical measures of type 2 diabetes and heart disease patients.

Methods

A randomized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District. Patients were recruited by sending invitations to randomly selected patients using the electronic health records system. Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), and steps (heart disease patients) once per week. The primary outcome was HRQL measured by the Short Form (36) Health Survey (SF-36) and glycosylated hemoglobin (HbA1c) among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels.

Results

A total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients’ unfamiliarity with mobile phones—of the 41 dropouts, 85% (11/13) of the heart disease patients and 88% (14/16) of the diabetes patients were familiar with mobile phones, whereas the corresponding percentages were 97.1% (231/238) and 98.6% (208/211), respectively, among the rest of the patients (P=.02 and P=.004). Withdrawal was also associated with heart disease patients’ comorbidities—40% (8/20) of the dropouts had at least one comorbidity, whereas the corresponding percentage was 18.9% (47/249) among the rest of the patients (P=.02). The intervention showed no statistically significant benefits over the current practice with regard to health-related quality of life—heart disease patients: beta=0.730 (P=.36) for the physical component score and beta=-0.608 (P=.62) for the mental component score; diabetes patients: beta=0.875 (P=.85) for the physical component score and beta=-0.770 (P=.52) for the mental component score. There was a significant difference in waist circumference in the type 2 diabetes group (beta=-1.711, P=.01). There were no differences in any other outcome variables.

Conclusions

A health coaching program supported with telemonitoring did not improve heart disease patients'' or diabetes patients'' quality of life or their clinical condition. There were indications that the intervention had a differential effect on heart patients and diabetes patients. Diabetes patients may be more prone to benefit from this kind of intervention. This should not be neglected when developing new ways for self-management of chronic diseases.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01310491","term_id":"NCT01310491"}}NCT01310491; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01310491","term_id":"NCT01310491"}}NCT01310491 (Archived by WebCite at http://www.webcitation.org/6Z8l5FwAM).     

Overcoming Addictions,a Web-Based Application,and SMART Recovery,an Online and In-Person Mutual Help Group for Problem Drinkers,Part 1: Three-Month Outcomes of a Randomized Controlled Trial

Background

Overcoming Addictions (OA) is an abstinence-oriented, cognitive behavioral, Web application based on the program of SMART Recovery. SMART Recovery is an organization that has adapted empirically supported treatment strategies for use in a mutual help framework with in-person meetings, online meetings, a forum, and other resources.

Objective

To evaluate the effectiveness of OA and SMART Recovery (SR) with problem drinkers who were new to SMART Recovery. Our experimental hypotheses were: (1) all groups will reduce their drinking and alcohol/drug-related consequences at follow-up compared to their baseline levels, (2) the OA condition will reduce their drinking and alcohol/drug-related consequences more than the control group (SR), and (3) the OA+SR condition will reduce their drinking and alcohol/drug-related consequences more than the control group (SR only).

Methods

We recruited 189 heavy problem drinkers primarily through SMART Recovery’s website and in-person meetings throughout the United States. We randomly assigned participants to (1) OA alone, (2) OA+attend SMART Recovery (SR) meetings (OA+SR), or (3) attend SR only. Baseline and follow-ups were conducted via GoToMeeting sessions with a Research Assistant (RA) and the study participant. We interviewed significant others to corroborate the participant’s self-report. Primary outcome measures included percent days abstinent (PDA), mean drinks per drinking day (DDD), and alcohol/drug-related consequences.

Results

The intent-to-treat analysis of the 3-month outcomes supported the first hypothesis but not the others. Participants in all groups significantly increased their percent days abstinent from 44% to 72% (P<.001), decreased their mean drinks per drinking day from 8.0 to 4.6 (P<.001), and decreased their alcohol/drug-related problems (P<.001). Actual use relationships were found for the OA groups, between SR online meetings and improvement in PDA (r=.261, P=.033). In addition in the OA groups, the number of total sessions of support (including SR & other meetings, counselor visits) was significantly related to PDA (r=.306, P=012) and amount of improvement in alcohol-related problems (r=.305, P=.012). In the SR only group, the number of face-to-face meetings was significantly related to all three dependent variables, and predicted increased PDA (r=.358, P=.003), fewer mean DDD (r=-.250, P=.039), and fewer alcohol-related problems (r=-.244, P=.045), as well as to the amount of improvement in all three of these variables. Six-month follow-ups have been completed, and the results are currently being analyzed.

Conclusions

These results support our first experimental hypothesis but not the second or third. All groups significantly increased their PDA and decreased both their mean DDD and their alcohol-related problems, which indicates that both interventions being investigated were equally effective in helping people recover from their problem drinking.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01389297","term_id":"NCT01389297"}}NCT01389297; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01389297","term_id":"NCT01389297"}}NCT01389297 (Archived by WebCite at http://www.webcitation.org/6Hh5JC7Yw).     

Comparing Effects in Regular Practice of E-Communication and Web-Based Self-Management Support Among Breast Cancer Patients: Preliminary Results From a Randomized Controlled Trial

BackgroundWhile Web-based interventions have been shown to assist a wide range of patients successfully in managing their illness, few studies have examined the relative contribution of different Web-based components to improve outcomes. Further efficacy trials are needed to test the effects of Web support when offered as a part of routine care.ObjectiveOur aim was to compare in regular care the effects of (1) an Internet-based patient provider communication service (IPPC), (2) WebChoice, a Web-based illness management system for breast cancer patients (IPPC included), and (3) usual care on symptom distress, anxiety, depression, (primary outcomes), and self-efficacy (secondary outcome). This study reports preliminary findings from 6 months’ follow-up data in a 12-month trial.MethodsWe recruited 167 patients recently diagnosed with breast cancer and undergoing treatment from three Norwegian hospitals. The nurse-administered IPPC allowed patients to send secure e-messages to and receive e-messages from health care personnel at the hospital where they were treated. In addition to the IPPC, WebChoice contains components for symptom monitoring, tailored information and self-management support, a diary, and communication with other patients. A total of 20 care providers (11 nurses, 6 physicians, and 3 social workers) were trained to answer questions from patients. Outcomes were measured with questionnaires at study entry and at study months 2, 4, and 6. Linear mixed models for repeated measures were fitted to compare effects on outcomes over time.ResultsPatients were randomly assigned to the WebChoice group (n=64), the IPPC group (n=45), or the usual care group (n=58). Response rates to questionnaires were 73.7% (123/167) at 2 months, 65.9 (110/167) at 4 months, and 62.3% (104/167) at 6 months. Attrition was similar in all study groups. Among those with access to WebChoice, 64% (41/64) logged on more than once and 39% (25/64) sent e-messages to care providers. In the IPPC group, 40% (18/45) sent e-messages. Linear mixed models analyses revealed that the WebChoice group reported significantly lower symptom distress (mean difference 0.16, 95% CI 0.06-0.25, P=.001), anxiety (mean difference 0.79, 95% CI 0.09-1.49, P=.03), and depression (mean difference 0.79, 95% CI 0.09-1.49, P=.03) compared with the usual care group. The IPPC group reported significant lower depression scores compared with the usual care group (mean difference 0.69, 95% CI 0.05-1.32, P=.03), but no differences were observed for symptom distress or anxiety. No significant differences in self-efficacy were found among the study groups.ConclusionsIn spite of practice variations and moderate use of the interventions, our results suggest that offering Web support as part of regular care can be a powerful tool to help patients manage their illness. Our finding that a nurse-administered IPPC alone can significantly reduce depression is particularly promising. However, the multicomponent intervention WebChoice had additional positive effects.

Trial Registration

Clinicaltrials.gov:{"type":"clinical-trial","attrs":{"text":"NCT00971009","term_id":"NCT00971009"}}NCT00971009; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT00971009","term_id":"NCT00971009"}}NCT00971009 (Archived by WebCite at http://www.webcitation.org/6USKezP0Y).     

It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial

BackgroundPhysical inactivity is a major public health problem. The It’s LiFe! monitoring and feedback tool embedded in the Self-Management Support Program (SSP) is an attempt to stimulate physical activity in people with chronic obstructive pulmonary disease or type 2 diabetes treated in primary care.ObjectiveOur aim was to evaluate whether the SSP combined with the use of the monitoring and feedback tool leads to more physical activity compared to usual care and to evaluate the additional effect of using this tool on top of the SSP.MethodsThis was a three-armed cluster randomised controlled trial. Twenty four family practices were randomly assigned to one of three groups in which participants received the tool + SSP (group 1), the SSP (group 2), or care as usual (group 3). The primary outcome measure was minutes of physical activity per day. The secondary outcomes were general and exercise self-efficacy and quality of life. Outcomes were measured at baseline after the intervention (4-6 months), and 3 months thereafter.ResultsThe group that received the entire intervention (tool + SSP) showed more physical activity directly after the intervention than Group 3 (mean difference 11.73, 95% CI 6.21-17.25; P<.001), and Group 2 (mean difference 7.86, 95% CI 2.18-13.54; P=.003). Three months after the intervention, this effect was still present and significant (compared to Group 3: mean difference 10.59, 95% CI 4.94-16.25; P<.001; compared to Group 2: mean difference 9.41, 95% CI 3.70-15.11; P<.001). There was no significant difference in effect between Groups 2 and 3 on both time points. There was no interaction effect for disease type.ConclusionsThe combination of counseling with the tool proved an effective way to stimulate physical activity. Counseling without the tool was not effective. Future research about the cost-effectiveness and application under more tailored conditions and in other target groups is recommended.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT01867970","term_id":"NCT01867970"}}NCT01867970, https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01867970","term_id":"NCT01867970"}}NCT01867970 (archived by WebCite at http://www.webcitation.org/6a2qR5BSr).     

Know Your Audience: Predictors of Success for a Patient-Centered Texting App to Augment Linkage to HIV Care in Rural Uganda

BackgroundDespite investments in infrastructure and evidence for high acceptability, few mHealth interventions have been implemented in sub-Saharan Africa.ObjectiveWe sought to (1) identify predictors of uptake of an mHealth application for a low-literacy population of people living with HIV (PLWH) in rural Uganda and (2) evaluate the efficacy of various short message service (SMS) text message formats to optimize the balance between confidentiality and accessibility.MethodsThe trial evaluated the efficacy of a SMS text messaging app to notify PLWH of their laboratory results and request return to care for those with abnormal test results. Participants with a normal laboratory result received a single SMS text message indicating results were normal. Participants with an abnormal test result were randomized to 1 of 3 message formats designed to evaluate trade-offs between clarity and privacy: (1) an SMS text message that stated results were abnormal and requested return to clinic (“direct”), (2) the same message protected by a 4-digit PIN code (“PIN”), and (3) the message “ABCDEFG” explained at enrollment to indicate abnormal results (“coded”). Outcomes of interest were (1) self-reported receipt of the SMS text message, (2) accurate identification of the message, and (3) return to care within 7 days (for abnormal results) or on the date of the scheduled appointment (for normal results). We fit regression models for each outcome with the following explanatory variables: sociodemographic characteristics, CD4 count result, ability to read a complete sentence, ability to access a test message on enrollment, and format of SMS text message.ResultsSeventy-two percent (234/385) of participants successfully receiving a message, 87.6% (219/250) correctly identified the message format, and 60.8% (234/385) returned to clinic at the requested time. Among participants with abnormal tests results (138/385, 35.8%), the strongest predictors of reported message receipt were the ability to read a complete sentence and a demonstrated ability to access a test message on enrollment. Participants with an abnormal result who could read a complete sentence were also more likely to accurately identify the message format (AOR 4.54, 95% CI 1.42-14.47, P=.01) and return to clinic appropriately (AOR 3.81, 95% CI 1.61-9.03, P=.002). Those who were sent a PIN-protected message were less likely to identify the message (AOR 0.11, 95% CI 0.03-0.44, P=.002) or return within 7 days (AOR 0.26, 95% CI 0.10-0.66, P=.005). Gender, age, and socioeconomic characteristics did not predict any outcomes and there were no differences in outcomes between those receiving direct or coded messages.ConclusionsConfirmed literacy at the time of enrollment was a robust predictor of SMS text message receipt, identification, and appropriate response for PLWH in rural Uganda. PIN-protected messages reduced odds of clinic return, but coded messages were as effective as direct messages and might augment privacy.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT 01579214","term_id":"NCT01579214"}}NCT 01579214; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01579214","term_id":"NCT01579214"}}NCT01579214 (Archived by WebCite at http://www.webcitation.org/6Ww8R4sKq).     

The Impact of a Web-Based App (eBalance) in Promoting Healthy Lifestyles: Randomized Controlled Trial

BackgroundThe use of Web-based apps to promote a healthy lifestyle is increasing, although most of these programs were not assessed using suitable epidemiological methods. We evaluated the effectiveness of a newly developed Web-based app in promoting a healthy lifestyle and educating adults on such lifestyles. We also analyzed predictors for success in acquiring and maintaining a healthy lifestyle.ObjectiveOur aim was to compare people receiving a new Web-based app with people who got an introductory lecture alone on healthy lifestyle, weight change, nutritional knowledge, and physical activity, and to identify predictors of success for maintaining a healthy lifestyle.MethodsSubjects were recruited from the community and were randomized into intervention and control groups. The intervention subjects received access to the app without any face-to-face support; the control subjects continued their standard lifestyle. Measurements were taken by the researcher at baseline and after 14 weeks and included weight and waist circumference. Nutritional knowledge, diet quality, and physical activity duration were obtained using online questionnaires. The new Web-based app was developed based on current US Department of Agriculture and Israel Ministry of Health recommendations for healthy lifestyle. The app provides tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity.ResultsOut of 99 subjects who were randomized into app and control groups, 85 participants (86%) completed the study, 56 in the intervention and 29 in the control group. The mean age was 47.9 (SD 12.3) years, and mean Body Mass Index was 26.2 (SD 3.9). Among the intervention group only, frequency of app use was 2.7 (SD 1.9) days/week. The mean change in physical activity was 63 (SD 20.8) minutes in the app group and -30 (SD 27.5) minutes in the control group (P=.02). The mean weight change was -1.44 (SD 0.4) kg in the app group and -0.128 (SD 0.36) kg in the control group (P=.03). Knowledge score increased significantly in the app group, 76 (SD 7.5) to 79 (SD 8.7) at the end of the study (P=.04) compared with the control group. Diet quality score also increased significantly at the end of the study, from 67 (SD 9.8) to 71 (SD 7.6; P<.001) in contrast to the control group. Success score (represents the success in maintaining healthy lifestyle) was higher among the app group (68%) compared with 36% in the control group (P<.001). The app frequency of use was significantly related to a higher success score (P<.001).ConclusionsWe showed a positive impact of a newly developed Web-based app on lifestyle indicators during an intervention of 14 weeks. These results are promising in the app’s potential to promote a healthy lifestyle, although larger and longer duration studies are needed to achieve more definitive conclusions.

Trial Registration

Clinicaltrial.gov number: {"type":"clinical-trial","attrs":{"text":"NCT01913496","term_id":"NCT01913496"}}NCT01913496; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01913496","term_id":"NCT01913496"}}NCT01913496 (Archived by WebCite at http://www.webcitation.org/6WSTUEPuJ).     

Associations of Internet Website Use With Weight Change in a Long-term Weight Loss Maintenance Program

Background

The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss.

Objective

This paper presents a secondary analysis of the subset of participants in the Internet arm and focuses on website use patterns and features associated with long-term weight maintenance.

Methods

Adults at risk for cardiovascular disease (CVD) who lost at least 4 kilograms in an initial 20-week group-based, behavioral weight-loss program were trained to use an interactive website for weight loss maintenance. Of the 348 participants, 37% were male and 38% were African American. Mean weight loss was 8.6 kilograms. Participants were encouraged to log in at least weekly and enter a current weight for the 30-month study period. The website contained features that encouraged setting short-term goals, creating action plans, and reinforcing self-management habits. The website also included motivational modules, daily tips, and tailored messages. Based on log-in and weight-entry frequency, we divided participants into three website use categories: consistent, some, and minimal.

Results

Participants in the consistent user group (n = 212) were more likely to be older (P = .002), other than African American (P = .02), and more educated (P = .01). While there was no significant difference between website use categories in the amount of Phase I change in body weight (P = .45) or income (P = .78), minimal website users (n = 75) were significantly more likely to have attended fewer Phase I sessions (P = .001) and had a higher initial body mass index (BMI) (P < .001). After adjusting for baseline characteristics including initial BMI, variables most associated with less weight regain included: number of log-ins (P = .001), minutes on the website (P < .001), number of weight entries (P = .002), number of exercise entries (P < .001), and sessions with additional use of website features after weight entry (P = .002).

Conclusion

Participants defined as consistent website users of an interactive behavioral website designed to promote maintenance of weight loss were more successful at maintaining long-term weight loss.

Trial Registration

{"type":"clinical-trial","attrs":{"text":"NCT00054925","term_id":"NCT00054925"}}NCT00054925; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00054925","term_id":"NCT00054925"}}NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue)     

Interactive Sections of an Internet-Based Intervention Increase Empowerment of Chronic Back Pain Patients: Randomized Controlled Trial

Background

Chronic back pain (CBP) represents a significant public health problem. As one of the most common causes of disability and sick leave, there is a need to develop cost-effective ways, such as Internet-based interventions, to help empower patients to manage their disease. Research has provided evidence for the effectiveness of Internet-based interventions in many fields, but it has paid little attention to the reasons why they are effective.

Objective

This study aims to assess the impact of interactive sections of an Internet-based self-management intervention on patient empowerment, their management of the disease, and, ultimately, health outcomes.

Methods

A total of 51 patients were recruited through their health care providers and randomly assigned to either an experimental group with full access to the Internet-based intervention or a control group that was denied access to the interactive sections and knew nothing thereof. The intervention took 8 weeks. A baseline, a mid-term after 4 weeks, and a final assessment after 8 weeks measured patient empowerment, physical exercise, medication misuse, and pain burden.

Results

All patients completed the study. Overall, the intervention had a moderate effect (F _1.52=2.83, P=.03, η²=0.30, d=0.55). Compared to the control group, the availability of interactive sections significantly increased patient empowerment (midterm assessment: mean difference=+1.2, P=.03, d=0.63; final assessment: mean difference=+0.8, P=.09, d=0.44) and reduced medication misuse (midterm assessment: mean difference=−1.5, P=.04, d=0.28; final assessment: mean difference=−1.6, P=.03, d=−0.55) in the intervention group. Both the frequency of physical exercise and pain burden decreased, but to equal measures in both groups.

Conclusions

Results suggest that interactive sections as part of Internet-based interventions can positively alter patients’ feelings of empowerment and help prevent medication misuse. Detrimental effects were not observed.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02114788","term_id":"NCT02114788"}}NCT02114788; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02114788","term_id":"NCT02114788"}}NCT02114788 (Archived by WebCite at http://www.webcitation.org/6ROXYVoPR).     

An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial

Background

Physical activity (PA) improves many facets of health. Despite this, the majority of American adults are insufficiently active. Adults who visit a physician complaining of chest pain and related cardiovascular symptoms are often referred for further testing. However, when this testing does not reveal an underlying disease or pathology, patients typically receive no additional standard care services. A PA intervention delivered within the clinic setting may be an effective strategy for improving the health of this population at a time when they may be motivated to take preventive action.

Objective

Our aim was to determine the effectiveness of a tailored, computer-based, interactive personal action planning session to initiate PA among a group of sedentary cardiac patients following exercise treadmill testing (ETT).

Methods

This study was part of a larger 2x2 randomized controlled trial to determine the impact of environmental and social-cognitive intervention approaches on the initiation and maintenance of weekly PA for patients post ETT. Participants who were referred to an ETT center but had a negative-test (ie, stress tests results indicated no apparent cardiac issues) were randomized to one of four treatment arms: (1) increased environmental accessibility to PA resources via the provision of a free voucher to a fitness facility in close proximity to their home or workplace (ENV), (2) a tailored social cognitive intervention (SC) using a “5 As”-based (ask, advise, assess, assist, and arrange) personal action planning tool, (3) combined intervention of both ENV and SC approaches (COMBO), or (4) a matched contact nutrition control (CON). Each intervention was delivered using a computer-based interactive session. A general linear model for repeated measures was conducted with change in PA behavior from baseline to 1-month post interactive computer session as the primary outcome.

Results

Sedentary participants (n=452; 34.7% participation rate) without a gym membership (mean age 58.57 years; 59% female, 78% white, 12% black, 11% Hispanic) completed a baseline assessment and an interactive computer session. PA increased across the study sample (F _1,441=30.03, P<.001). However, a time by condition interaction (F _3,441=8.33, P<.001) followed by post hoc analyses indicated that SC participants exhibited a significant increase in weekly PA participation (mean 45.1, SD 10.2) compared to CON (mean -2.5, SD 10.8, P=.004) and ENV (mean 8.3, SD 8.1, P<.05). Additionally, COMBO participants exhibited a significant increase in weekly PA participation (mean 53.4, SD 8.9) compared to CON (P<.001) and ENV (P=.003) participants. There were no significant differences between ENV and CON or between SC and COMBO.

Conclusions

A brief, computer-based, interactive personal action planning session may be an effective tool to initiate PA within a health care setting, in particular as part of the ETT system.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00432133","term_id":"NCT00432133"}}NCT00432133, http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00432133","term_id":"NCT00432133"}}NCT00432133 (Archived by WebCite at http://www.webcitation.org/6aa8X3mw1).