Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial

Background

The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale.

Objective

Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant.

Methods

A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test.

Results

Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike.

Conclusions

The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02229409","term_id":"NCT02229409"}}NCT02229409, https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02229409","term_id":"NCT02229409"}}NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe)     

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).     

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).     

Daily Text Messaging for Weight Control Among Racial and Ethnic Minority Women: Randomized Controlled Pilot Study

Background

Daily self-monitoring of diet and physical activity behaviors is a strong predictor of weight loss success. Text messaging holds promise as a viable self-monitoring modality, particularly among racial/ethnic minority populations.

Objective

This pilot study evaluated the feasibility of a text messaging intervention for weight loss among predominantly black women.

Methods

Fifty obese women were randomized to either a 6-month intervention using a fully automated system that included daily text messages for self-monitoring tailored behavioral goals (eg, 10,000 steps per day, no sugary drinks) along with brief feedback and tips (n=26) or to an education control arm (n=24). Weight was objectively measured at baseline and at 6 months. Adherence was defined as the proportion of text messages received in response to self-monitoring prompts.

Results

The average daily text messaging adherence rate was 49% (SD 27.9) with 85% (22/26) texting self-monitored behavioral goals 2 or more days per week. Approximately 70% (16/23) strongly agreed that daily texting was easy and helpful and 76% (16/21) felt the frequency of texting was appropriate. At 6 months, the intervention arm lost a mean of 1.27 kg (SD 6.51), and the control arm gained a mean of 1.14 kg (SD 2.53; mean difference –2.41 kg, 95% CI –5.22 to 0.39; P=.09). There was a trend toward greater text messaging adherence being associated with greater percent weight loss (r=–.36; P=.08), but this did not reach statistical significance. There was no significant association between goal attainment and text messaging adherence and no significant predictors of adherence.

Conclusions

Given the increasing penetration of mobile devices, text messaging may be a useful self-monitoring tool for weight control, particularly among populations most in need of intervention.

Trial Registration

Clinicaltrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT00939081","term_id":"NCT00939081"}}NCT00939081; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT00939081","term_id":"NCT00939081"}}NCT00939081 (Archived by WebCite at http://www.webcitation.org/6KiIIcnk1).     

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 Patients’ Opinions on the Hospital Discharge Process Collected With a Self-Reported Questionnaire Completed Via the Internet or Through a Telephone Survey: An Ancillary Study of the SENTIPAT Randomized Controlled Trial

Background

Hospital discharge, a critical stage in the hospital-to-home transition of patient care, is a complex process with potential dysfunctions having an impact on patients’ health on their return home. No study has yet reported the feasibility and usefulness of an information system that would directly collect and transmit, via the Internet, volunteer patients’ opinions on their satisfaction concerning the organization of hospital discharge.

Objective

Our primary objective was to compare patients’ opinions on the discharge process collected with 2 different methods: self-questionnaire completed on a dedicated website versus a telephone interview. The secondary goal was to estimate patient satisfaction.

Methods

We created a questionnaire to examine hospital discharge according to 3 dimensions: discharge logistics organization, preplanned posthospital continuity-of-care organization, and patients’ impressions at the time of discharge. A satisfaction score (between 0 and 1) for each of those dimensions and an associated total score were calculated. Taking advantage of the randomized SENTIPAT trial that questioned patients recruited at hospital discharge about the evolution of their health after returning home and randomly assigned them to complete a self-questionnaire directly online or during a telephone interview, we conducted an ancillary study comparing satisfaction with the organization of hospital discharge for these 2 patient groups. The questionnaire was proposed to 1141 patients included in the trial who were hospitalized for ≥2 days, among whom 867 eligible patients had access to the Internet at home and were randomized to the Internet or telephone group.

Results

Of the 1141 patients included, 755 (66.17%) completed the questionnaire. The response rates for the Internet (39.1%, 168/430) and telephone groups (87.2%, 381/437) differed significantly (P<.001), but their total satisfaction scores did not (P=.08) nor did the satisfaction subscores (P=.58 for discharge logistics organization, P=.12 for preplanned posthospital continuity-of-care organization, and P=.35 for patients’ impressions at the time of discharge). The total satisfaction score (median 0.83, IQR 0.72-0.92) indicated the patients’ high satisfaction.

Conclusions

The direct transmission of personal health data via the Internet requires patients’ active participation and those planning surveys in the domain explored in this study should anticipate a lower response rate than that issued from a similar survey conducted by telephone interviews. Nevertheless, collecting patients’ opinions on their hospital discharge via the Internet proved operational; study results indicate that conducting such surveys via the Internet yields similar estimates to those obtained via a telephone survey. The results support the establishment of a permanent dedicated website that could also be used to obtain users’ opinions on other aspects of their hospital stay and follow-up.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01769261","term_id":"NCT01769261"}}NCT01769261; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01769261","term_id":"NCT01769261"}}NCT01769261 (Archived by WebCite at http://www.webcitation.org/6ZDF5bdQb).     

A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder

Background

Internet-based cognitive behavior therapy (CBT) has been shown to be a promising method to disseminate cognitive behavior therapy for social anxiety disorder (SAD). Several trials have demonstrated that Internet-based CBT can be effective for SAD in the shorter term. However, the long-term effects of Internet-based CBT for SAD are less well known.

Objective

Our objective was to investigate the effect of Internet-based CBT for SAD 5 years after completed treatment.

Method

We conducted a 5-year follow-up study of 80 persons with SAD who had undergone Internet-based CBT. The assessment comprised a diagnostic interview and self-report questionnaires. The main outcome measure was the Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR). Additional measures of social anxiety were the Social Interaction Anxiety Scale (SIAS) and the Social Phobia Scale (SPS). Attrition rates were low: 89% (71/80) of the participants completed the diagnostic interview and 80% (64/80) responded to the questionnaires.

Results

Mixed-effect models analysis showed a significant effect of time on the three social anxiety measures, LSAS-SR, SIAS, and SPS (F _{3,98 -102} = 16.05 - 29.20, P < .001) indicating improvement. From baseline to 5-year follow-up, participants’ mean scores on the LSAS-SR were reduced from 71.3 (95% confidence interval [CI] 66.1-76.5) to 40.3 (95% CI 35.2 - 45.3). The effect sizes of the LSAS-SR were large (Cohen’s d range 1.30 - 1.40, 95% CI 0.77 - 1.90). Improvements gained at the 1-year follow-up were sustained 5 years after completed treatment.

Conclusions

Internet-based CBT for SAD is a treatment that can result in large and enduring effects.

Trial registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01145690","term_id":"NCT01145690"}}NCT01145690; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01145690","term_id":"NCT01145690"}}NCT01145690 (Archived by WebCite at http://www.webcitation.org/5ygRxDLfK)     

Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial

Background

Previous studies on Internet-based treatment with minimal therapist guidance have shown promising results for several specific diagnoses.

Objective

To (1) investigate the effects of a tailored, therapist-guided, Internet-based treatment for individuals with reoccurring panic attacks, and (2) to examine whether people in different age groups (18–30 years and 31–45 years) would respond differently to the treatment.

Methods

We recruited 149 participants from an online list of individuals having expressed an interest in Internet treatment. Screening consisted of online questionnaires followed by a telephone interview. A total of 57 participants were included after a semistructured diagnostic interview, and they were randomly assigned to an 8-week treatment program (n = 29) or to a control condition (n = 28). Treatment consisted of individually prescribed cognitive behavior therapy text modules in conjunction with online therapist guidance. The control group consisted of people on a waitlist who later received treatment.

Results

All dependent measures improved significantly immediately following treatment and at the 12-month follow-up. The between-group effect size on the primary outcome measure, the Panic Disorder Severity Scale, was d = 1.41 (95% confidence interval 0.81–1.95) at posttreatment. The within-group effect size from pretreatment to 12-month follow-up was d = 1.66 (95% confidence interval 1.14–2.35). Age group had no effect, suggesting that age did not influence the outcome.

Conclusions

Tailoring an Internet-based treatment can be a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms. Younger adults benefit as much as adults over 30 years and up to 45 years of age.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01296321","term_id":"NCT01296321"}}NCT01296321; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01296321","term_id":"NCT01296321"}}NCT01296321 (Archived by WebCite at http://www.webcitation.org/65wddsqlL)     

Effectiveness of a Web-Based,Computer-Tailored,Pedometer-Based Physical Activity Intervention for Adults: A Cluster Randomized Controlled Trial

Background

Computer-tailored physical activity (PA) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level. However, personalized advice is mostly provided based on subjectively measured PA, which is not very accurate and might result in the delivery of advice that is not credible or effective. Therefore, an innovative computer-tailored PA advice was developed, based on objectively pedometer-measured PA.

Objective

The study aim was to evaluate the effectiveness of a computer-tailored, pedometer-based PA intervention in working adults.

Methods

Participants (≥18 years) were recruited between May and December 2012 from eight Flemish workplaces. These workplaces were allocated randomly to an intervention or control group. Intervention group participants (n=137) received (1) a booklet with information on how to increase their steps, (2) a non-blinded pedometer, and (3) an Internet link to request computer-tailored step advice. Control group participants (n=137) did not receive any of the intervention components. Self-reported and pedometer-based PA were assessed at baseline (T0), and 1 month (T1) and 3 months (T2) months post baseline. Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample (ie, adults not reaching 10,000 steps a day at baseline).

Results

The recruitment process resulted in 274 respondents (response rate of 15.1%) who agreed to participate, of whom 190 (69.3%) belonged to the at-risk sample. Between T0 and T1 (1-month post baseline), significant intervention effects were found for participants’ daily step counts in both the total sample (P=.004) and the at-risk sample (P=.001). In the at-risk sample, the intervention effects showed a daily step count increase of 1056 steps in the intervention group, compared to a decrease of 258 steps in the control group. Comparison of participants’ self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants’ daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant.

Conclusions

A computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy).     

Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial

Background

Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program.

Objective

The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability.

Methods

A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points.

Results

Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant.

Conclusions

Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00694018","term_id":"NCT00694018"}}NCT00694018; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00694018","term_id":"NCT00694018"}}NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).     

Adherence to Self-Monitoring via Interactive Voice Response Technology in an eHealth Intervention Targeting Weight Gain Prevention Among Black Women: Randomized Controlled Trial

Background

eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity.

Objective

This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention.

Methods

The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call.

Results

Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ≥80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =−.22; P=.04) and participants with an IVR completion rate ≥80% had significantly greater weight loss compared to those with an IVR completion rate <80% (−1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference −0.94 kg, 95% CI −1.64 to −0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring.

Conclusions

Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00938535","term_id":"NCT00938535"}}NCT00938535; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00938535","term_id":"NCT00938535"}}NCT00938535 (Archived by WebCite at http://www.webcitation.org/6P1FFNJRs).     

Effects of a Web-Based Patient Activation Intervention to Overcome Clinical Inertia on Blood Pressure Control: Cluster Randomized Controlled Trial

Background

Only approximately half of patients with hypertension have their blood pressure controlled, due in large part to the tendency of primary care providers (PCPs) not to intensify treatment when blood pressure values are elevated.

Objective

This study tested the effect of an intervention designed to help patients ask questions at the point of care to encourage PCPs to appropriately intensify blood pressure treatment.

Methods

PCPs and their patients with hypertension (N=500) were recruited by letter and randomized into 2 study groups: (1) intervention condition in which patients used a fully automated website each month to receive tailored messages suggesting questions to ask their PCP to improve blood pressure control, and (2) control condition in which a similar tool suggested questions to ask about preventive services (eg, cancer screening). The Web-based tool was designed to be used during each of the 12 study months and before scheduled visits with PCPs. The primary outcome was the percentage of patients in both conditions with controlled blood pressure.

Results

Of 500 enrolled patients (intervention condition: n=282; control condition: n=218), 418 (83.6%) completed the 12-month follow-up visit. At baseline, 289 (61.5%) of participants had controlled blood pressure. Most (411/500, 82.2%) participants used the intervention during at least 6 of 12 months and 222 (62.5%) reported asking questions directly from the Web-based tool. There were no group differences in asking about medication intensification and there were no differences in blood pressure control after 12 months between the intervention condition (201/282, 71.3%) and control condition (143/218, 65.6%; P=.27) groups. More intervention condition participants discussed having a creatinine test (92, 52.6% vs 49, 35.5%; P=.02) and urine protein test (81, 44.8% vs 21, 14.6%; P<.001), but no group differences were observed in the rate of testing. The control condition participants reported more frequent discussions about tetanus and pneumonia vaccines and reported more tetanus (30, 13.8% vs 15, 5.3%; P=.02) and pneumonia (25, 11.5% vs 16, 5.7%; P=.02) vaccinations after 12 months.

Conclusions

The use of an interactive website designed to overcome clinical inertia for hypertension care did not lead to improvements in blood pressure control. Participant adherence to the intervention was high. The control intervention led to positive changes in the use of preventive services (eg, tetanus immunization) and the intervention condition led to more discussions of hypertension-relevant tests (eg, serum creatinine and urine protein). By providing patients with individually tailored questions to ask during PCP visits, this study demonstrated that participants were likely to discuss the questions with PCPs. These discussions did not, however, lead to improvements in blood pressure control.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00377208","term_id":"NCT00377208"}}NCT00377208; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00377208","term_id":"NCT00377208"}}NCT00377208 (Archived by WebCite at http://www.webcitation.org/6IqWiPLon).     

Development of a Twitter-Based Intervention for Smoking Cessation that Encourages High-Quality Social Media Interactions via Automessages

Background

The medical field seeks to use social media to deliver health interventions, for example, to provide low-cost, self-directed, online self-help groups. However, engagement in online groups is often low and the informational content may be poor.

Objective

The specific study aims were to explore if sending automessages to online self-help groups encouraged engagement and to see if overall or specific types of engagement related to abstinence.

Methods

We conducted a Stage I Early Therapy Development Trial of a novel social media intervention for smoking cessation called Tweet2Quit that was delivered online over closed, 20-person quit-smoking groups on Twitter in 100 days. Social media such as Twitter traditionally involves non-directed peer-to-peer exchanges, but our hybrid social media intervention sought to increase and direct such exchanges by sending out two types of autocommunications daily: (1) an “automessage” that encouraged group discussion on an evidence-based cessation-related or community-building topic, and (2) individualized “autofeedback” to each participant on their past 24-hour tweeting. The intervention was purposefully designed without an expert group facilitator and with full automation to ensure low cost, easy implementation, and broad scalability. This purely Web-based trial examined two online quit-smoking groups with 20 members each. Participants were adult smokers who were interested in quitting and were recruited using Google AdWords. Participants’ tweets were counted and content coded, distinguishing between responses to the intervention’s automessages and spontaneous tweets. In addition, smoking abstinence was assessed at 7 days, 30 days, and 60 days post quit date. Statistical models assessed how tweeting related to abstinence.

Results

Combining the two groups, 78% (31/40) of the members sent at least one tweet; and on average, each member sent 72 tweets during the 100-day period. The automessage-suggested discussion topics and participants’ responses to those daily automessages were related in terms of their content (r=.75, P=.012). Responses to automessages contributed 22.78% (653/2867) of the total tweets; 77.22% (2214/2867) were spontaneous. Overall tweeting related only marginally to abstinence (OR 1.03, P=.086). However, specific tweet content related to abstinence including tweets about setting of a quit date or use of nicotine patches (OR 1.52, P=.024), countering of roadblocks to quitting (OR 1.76, P=.008) and expressions of confidence about quitting (OR 1.71, SE 0.42, P=.032). Questionable, that is, non-evidence-based, information about quitting did not relate to abstinence (OR 1.12, P=.278).

Conclusions

A hybrid social media intervention that combines traditional online social support with daily automessages appears to hold promise for smoking cessation. This hybrid approach capitalizes on social media’s spontaneous real-time peer-to-peer exchanges but supplements this with daily automessages that group members respond to, bolstering and sustaining the social network and directing the information content. Highly engaging, this approach should be studied further.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01602536","term_id":"NCT01602536"}}NCT01602536; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01602536","term_id":"NCT01602536"}}NCT01602536 (Archived by WebCite at http://www.webcitation.org/6WGbt0o1K)     

A Text Message–Based Intervention for Weight Loss: Randomized Controlled Trial

Background

To our knowledge, no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS (Short Message Service: text) and MMS (Multimedia Message Service: small picture) messages transmitted via mobile phones.

Objective

This paper describes the development and evaluation of a text message–based intervention designed to help individuals lose or maintain weight over 4 months.

Methods

The study was a randomized controlled trial, with participants being exposed to one of the following two conditions, lasting 16 weeks: (1) receipt of monthly printed materials about weight control; (2) an intervention that included personalized SMS and MMS messages sent two to five times daily, printed materials, and brief monthly phone calls from a health counselor. The primary outcome was weight at the end of the intervention. A mixed-model repeated-measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period. Analysis of covariance (ANCOVA) models examined weight change between baseline and 4 months after adjusting for baseline weight, sex, and age.

Results

A total of 75 overweight men and women were randomized into one of the two groups, and 65 signed the consent form, completed the baseline questionnaire, and were included in the analysis. At the end of 4 months, the intervention group (n = 33) lost more weight than the comparison group (−1.97 kg difference, 95% CI −0.34 to −3.60 kg, P = .02) after adjusting for sex and age. Intervention participants’ adjusted average weight loss was 2.88 kg (3.16%). At the end of the study, 22 of 24 (92%) intervention participants stated that they would recommend the intervention for weight control to friends and family.

Conclusions

Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00415870","term_id":"NCT00415870"}}NCT00415870; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00415870","term_id":"NCT00415870"}}NCT00415870 (Archived by WebCite at http://www.webcitation.org/5dnolbkFt)     

Leveraging Text Messaging and Mobile Technology to Support Pediatric Obesity-Related Behavior Change: A Qualitative Study Using Parent Focus Groups and Interviews

Background

Text messaging (short message service, SMS) is a widely accessible and potentially cost-effective medium for encouraging behavior change. Few studies have examined text messaging interventions to influence child health behaviors or explored parental perceptions of mobile technologies to support behavior change among children.

Objective

Our aim was to examine parental acceptability and preferences for text messaging to support pediatric obesity-related behavior change.

Methods

We conducted focus groups and follow-up interviews with parents of overweight and obese children, aged 6-12 years, seen for “well-child” care in eastern Massachusetts. A professional moderator used a semistructured discussion guide and sample text messages to catalyze group discussions. Seven participants then received 3 weeks of text messages before a follow-up one-on-one telephone interview. All focus groups and interviews were recorded and transcribed verbatim. Using a framework analysis approach, we systematically coded and analyzed group and interview data to identify salient and convergent themes.

Results

We reached thematic saturation after five focus groups and seven follow-up interviews with a total of 31 parents of diverse race/ethnicity and education levels. Parents were generally enthusiastic about receiving text messages to support healthy behaviors for their children and preferred them to paper or email communication because they are brief and difficult to ignore. Participants anticipated high responsiveness to messaging endorsed by their child’s doctor and indicated they would appreciate messages 2-3 times/week or more as long as content remains relevant. Suggestions for maintaining message relevance included providing specific strategies for implementation and personalizing information. Most felt the negative features of text messaging (eg, limited message size) could be overcome by providing links within messages to other media including email or websites.

Conclusions

Text messaging is a promising medium for supporting pediatric obesity-related behavior change. Parent perspectives could assist in the design of text-based interventions.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01565161","term_id":"NCT01565161"}}NCT01565161; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01565161","term_id":"NCT01565161"}}NCT01565161 (Archived by WebCite at http://www.webcitation.org/6LSaqFyPP).     

Exposure to a Patient-Centered,Web-Based Intervention for Managing Cancer Symptom and Quality of Life Issues: Impact on Symptom Distress

Background

Effective eHealth interventions can benefit a large number of patients with content intended to support self-care and management of both chronic and acute conditions. Even though usage statistics are easily logged in most eHealth interventions, usage or exposure has rarely been reported in trials, let alone studied in relationship to effectiveness.

Objective

The intent of the study was to evaluate use of a fully automated, Web-based program, the Electronic Self Report Assessment-Cancer (ESRA-C), and how delivery and total use of the intervention may have affected cancer symptom distress.

Methods

Patients at two cancer centers used ESRA-C to self-report symptom and quality of life (SxQOL) issues during therapy. Participants were randomized to ESRA-C assessment only (control) or the ESRA-C intervention delivered via the Internet to patients’ homes or to a tablet at the clinic. The intervention enabled participants to self-monitor SxQOL and receive self-care education and customized coaching on how to report concerns to clinicians. Overall and voluntary intervention use were defined as having ≥2 exposures, and one non-prompted exposure to the intervention, respectively. Factors associated with intervention use were explored with Fisher’s exact test. Propensity score matching was used to select a sample of control participants similar to intervention participants who used the intervention. Analysis of covariance (ANCOVA) was used to compare change in Symptom Distress Scale (SDS-15) scores from pre-treatment to end-of-study by groups in the matched sample.

Results

Radiation oncology participants used the intervention, overall and voluntarily, more than medical oncology and transplant participants. Participants who were working and had more than a high school education voluntarily used the intervention more. The SDS-15 score was reduced by an estimated 1.53 points (P=.01) in the intervention group users compared to the matched control group.

Conclusions

The intended effects of a Web-based, patient-centered intervention on cancer symptom distress were modified by intervention use frequency. Clinical and personal demographics influenced voluntary use.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00852852","term_id":"NCT00852852"}}NCT00852852; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00852852","term_id":"NCT00852852"}}NCT00852852 (Archived by WebCite at http://www.webcitation.org/6YwAfwWl7).     

A Web-Based Psychoeducational Program for Informal Caregivers of Patients With Alzheimer’s Disease: A Pilot Randomized Controlled Trial

Background

Although several face-to-face programs are dedicated to informal caregivers of persons with dementia, they are not always accessible to overburdened or isolated caregivers. Based on a face-to-face intervention program, we adapted and designed a Web-based fully automated psychoeducational program (called Diapason) inspired by a cognitive approach.

Objective

This study aimed to evaluate through a pilot unblinded randomized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer’s disease (PWAD) based on a mixed methods research design.

Methods

We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris, France. They either received the Web-based intervention and usual care for 3 months (experimental group, n=25) or only usual care (control group, n=24). Caregivers’ perceived stress (PSS-14, primary outcome), self-efficacy, burden, perceived health status, and depression (secondary outcomes) were measured during 3 face-to-face on-site visits: at baseline, at the end of the program (month 3), and after follow-up (month 6). Additionally, semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis.

Results

Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups (P=.98). The experimental group significantly improved their knowledge of the illness (d=.79, P=.008) from baseline to month 3. Of the 25 participants allocated to the experimental group, 17 (71%) finished the protocol and entirely viewed at least 10 of 12 online sessions. On average, participants used the website 19.72 times (SD 12.88) and were connected for 262.20 minutes (SD 270.74). The results of the satisfaction questionnaire showed that most participants considered the program to be useful (95%, 19/20), clear (100%, 20/20), and comprehensive (85%, 17/20). Significant correlations were found between relationship and caregivers’ program opinion (P=.01). Thus, positive opinions were provided by husbands and sons (3/3), whereas qualified opinions were primarily reported by daughters (8/11). Female spouses expressed negative (2/3) or neutral opinions (1/3). Caregivers expected more dynamic content and further interaction with staff and peers.

Conclusions

In this study, quantitative results were inconclusive owing to small sample size. Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers. Caregivers did not rule out their interest in this kind of intervention provided that it met their needs. More dynamic, personalized, and social interventions are desirable. Our recruitment issues pointed out the necessity of in-depth studies about caregivers’ help-seeking behaviors and readiness factors.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01430286","term_id":"NCT01430286"}}NCT01430286; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01430286","term_id":"NCT01430286"}}NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).     

Interpreting the outcomes of automated internet-based randomized trials: example of an International Smoking Cessation Study

Background

Smoking is one of the largest contributors to the global burden of disease. Internet interventions have been shown to reduce smoking rates successfully. However, improved methods of evaluating effectiveness need to be developed for large-scale Internet intervention trials.

Objective

To illustrate a method to interpret outcomes of large-scale, fully automated, worldwide Internet intervention trials.

Methods

A fully automated, international, Internet-based smoking cessation randomized controlled trial was conducted in Spanish and English, with 16,430 smokers from 165 countries. The randomized controlled trial replicated a published efficacy trial in which, to reduce follow-up attrition, 1000 smokers were followed up by phone if they did not provide online follow-up data.

Results

The 7-day self-reported abstinence rates ranged from 36.18% (2239/6189) at 1 month to 41.34% (1361/3292) at 12 months based on observed data. Given high rates of attrition in this fully automated trial, when participants unreachable at follow-up were presumed to be smoking, the abstinence rates ranged from 13.63% (2239/16.430) at 1 month to 8.28% (1361/16,430) at 12 months. We address the problem of interpreting results with high follow-up attrition rates and propose a solution based on a smaller study with intensive phone follow-up.

Conclusions

Internet-based smoking cessation interventions can help large numbers of smokers quit. Large-scale international outcome studies can be successfully implemented using automated Internet sites. Interpretation of the studies’ results can be aided by extrapolating from results obtained from subsamples that are followed up by phone or similar cohort maintenance methods.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00721786","term_id":"NCT00721786"}}NCT00721786; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00721786","term_id":"NCT00721786"}}NCT00721786 (Archived by WebCite at http://www.webcitation.org/63mhoXYPw)