Cardiovascular Health Effects of Internet-Based Encouragements to Do Daily Workplace Stair-Walks: Randomized Controlled Trial

Background

Although the hazardous health effects of a sedentary lifestyle are well known, many adults struggle with regular physical activity. Simple and efficient encouragements for increased physical activity are needed.

Objective

To determine the effect on cardiovascular health of email-based encouragements to do daily stair-walks at work together with colleagues among adults in sedentary occupations.

Methods

A single-blind randomized controlled trial was performed at a large administrative company in Copenhagen, Denmark. Participants were 160 office workers (125 women, 35 men; mean age 42 years, SD 10; sitting 89.5% of work time). At baseline, aerobic fitness was 37 mL/min/kg (SD 9), mean blood pressure was 118/79 mmHg (SD 14/9), and mean body mass index (BMI) was 23 kg/m² (SD 4). Participants were randomly assigned (2:1 ratio) to an email group receiving weekly email-based encouragements to walk the stairs for 10 minutes a day or to a control group receiving weekly reminders to continue their usual physical activities. The primary outcome was the change from baseline to 10-week follow-up in aerobic fitness determined from a maximal cycle test. The examiner was blinded to group allocation.

Results

Adherence to the email encouragements was fairly high with 82.7% of the participants performing at least 3 sessions of 10-minute stair-walks per week (mean 3.3, SD 1.3). Mean heart rate reached 167 beats/min (SD 10) during stair-walks. In the intention-to-treat analysis, aerobic fitness increased 1.45 mL/min/kg (95% CI 0.64-2.27) at 10-week follow-up in the email group compared with the control group. In participants with low aerobic fitness at baseline (n=56), aerobic fitness increased 1.89 mL/min/kg (95% CI 0.53-3.24), and systolic and diastolic blood pressure decreased 4.81 mmHg (95% CI 0.47-9.16) and 2.67 mmHg (95% CI 0.01-5.32), respectively, in the email group compared with the control group. Body weight decreased in the email group of those with low aerobic fitness compared with the control group, but this was not statistically significant.

Conclusions

Simple and inexpensive email-based encouragements to do daily stair-walks together with colleagues at work improves cardiovascular health among adults in sedentary occupations. There exists an enormous potential to prevent the hazardous health effects of a sedentary lifestyle through the use of email-based encouragements to do short bouts of physical activity at the workplace.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01293253","term_id":"NCT01293253"}}NCT01293253; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01293253","term_id":"NCT01293253"}}NCT01293253 (Archived by WebCite at http://www.webcitation.org/6HWG2jw68).     

Surviving and Thriving With Cancer Using a Web-Based Health Behavior Change Intervention: Randomized Controlled Trial

Background

Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors.

Objective

The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors.

Methods

Participants (n=352) were recruited from oncology clinics, a tumor registry, as well as through online mechanisms, such as Facebook and the Association of Cancer Online Resources (ACOR). Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment. Participants were randomly assigned to the Web-based program or a delayed-treatment control condition.

Results

In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls. There were no significant changes in fruit and vegetable consumption or other outcomes.

Conclusions

The Web-based intervention impacted insomnia and exercise; however, a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Thus, the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited. Future work is discussed, with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit, such as in regard to social networking.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00962494","term_id":"NCT00962494"}}NCT00962494; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00962494","term_id":"NCT00962494"}}NCT00962494 (Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q).     

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).     

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)     

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).     

Web-Enhanced Tobacco Tactics With Telephone Support Versus 1-800-QUIT-NOW Telephone Line Intervention for Operating Engineers: Randomized Controlled Trial

Background

Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups.

Objective

The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced “Tobacco Tactics” intervention targeting operating engineers (heavy equipment operators) compared to the “1-800-QUIT-NOW” telephone line.

Methods

Operating engineers (N=145) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy (NRT) or to the 1-800-QUIT-NOW telephone line, which provided an equal number of phone calls and NRT. The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up. The outcomes were compared using chi-square tests, t tests, generalized mixed models, and logistic regression models.

Results

The average age was 42 years and most were male (115/145, 79.3%) and white (125/145, 86.2%). Using an intent-to-treat analysis, the Tobacco Tactics website group showed significantly higher quit rates (18/67, 27%) than the 1-800-QUIT NOW group (6/78, 8%) at 30-day follow-up (P=.003), but this difference was no longer significant at 6-month follow-up. There were significantly more positive changes in harm reduction measures (quit attempts, number of cigarettes smoked per day, and nicotine dependence) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group. Compared to participants in the 1-800-QUIT NOW group, significantly more of those in the Tobacco Tactics website group participated in the interventions, received phone calls and NRT, and found the intervention helpful.

Conclusions

The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention. Longer counseling sessions may be needed to improve 6-month cessation rates.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01124110","term_id":"NCT01124110"}}NCT01124110; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01124110","term_id":"NCT01124110"}}NCT01124110 (Archived by WebCite at http://www.webcitation.org/6TfKN5iNL).     

Mobile-Web App to Self-Manage Low Back Pain: Randomized Controlled Trial

Background

Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines.

Objective

This study evaluated the efficacy of a mobile-Web intervention called “FitBack” to help users implement self-tailored strategies to manage and prevent NLBP occurrences.

Methods

A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments.

Results

Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain.

Conclusions

This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users’ preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01950091","term_id":"NCT01950091"}}NCT01950091; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01950091","term_id":"NCT01950091"}}NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77).     

MomMoodBooster Web-Based Intervention for Postpartum Depression: Feasibility Trial Results

Background

Postpartum depression (PPD)—the most common complication of childbirth—is a significant and prevalent public health problem that severely disrupts family interactions and can result in serious lasting consequences to the health of women and the healthy development of infants. These consequences increase in severity when left untreated; most women with PPD do not obtain help due to a range of logistical and attitudinal barriers.

Objective

This pilot study was designed to test the feasibility, acceptability, and potential efficacy of an innovative and interactive guided Web-based intervention for postpartum depression, MomMoodBooster (MMB).

Methods

A sample of 53 women who satisfied eligibility criteria (<9 months postpartum, ≥18 years of age, home Internet access and use of personal email, Edinburgh Postnatal Depression Survey score of 12-20 or Patient Health Questionnaire score from 10-19) were invited to use the MMB program. Assessments occurred at screening/pretest, posttest (3 months following enrollment), and at 6 months follow-up.

Results

All six sessions of the program were completed by 87% (46/53) of participants. Participants were engaged with the program: visit days (mean 15.2, SD 8.7), number of visits (mean 20.1, SD 12.2), total duration of visits in hours (mean 5.1, SD 1.3), and number of sessions viewed out of six (mean 5.6, SD 1.3) all support high usage. Posttest data were collected from 89% of participants (47/53) and 6-month follow-up data were collected from 87% of participants (46/53). At pretest, 55% (29/53) of participants met PHQ-9 criteria for minor or major depression. At posttest, 90% (26/29) no longer met criteria.

Conclusions

These findings support the expanded use and additional testing of the MMB program, including its implementation in a range of clinical and public health settings.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00942721","term_id":"NCT00942721"}}NCT00942721; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00942721","term_id":"NCT00942721"}}NCT00942721 (Archived by WebCite at http://www.webcitation.org/6KjYDvYkQ).     

Partnership for Health-2, A Web-Based Versus Print Smoking Cessation Intervention for Childhood and Young Adult Cancer Survivors: Randomized Comparative Effectiveness Study

Background

Smoking among cancer survivors increases the risk of late effects and second cancers. This article reports on Partnership for Health-2 (PFH-2)—an effort to develop an effective and scalable version of Partnership for Health (PFH), which was a previously tested peer-delivered telephone counseling program that doubled smoking cessation rates among childhood cancer survivors who smoke.

Objective

This paper presents results from a randomized controlled trial evaluating the effectiveness of PFH-2 in targeted and tailored Web-based versus print formats. The overall goal was to determine whether the intervention outcomes in these self-guided scalable formats approximate what was found in a more intensive telephone counseling program.

Methods

This study was a randomized controlled trial with a 15-month follow-up that included 374 smokers who were survivors of childhood or young adult cancers, recruited from five survivorship clinics. Participants were randomly assigned to a Web-based or print format of the PFH intervention; all had access to free pharmacotherapy. The website was designed to provide new content at each log-on, and a peer counselor moderated a forum/chat feature. The primary outcome was smoking status at 15 months post randomization.

Results

In total, 58.3% (77/132) of Web participants logged on at least once (mean visits 3.25). Using multiple imputation methods for missing data, there were similar rates of cessation in the two arms (print: 20/128, 15.6%; Web: 33/201, 6.4%), and no differences in quit attempts or readiness to quit. The quit rates were equivalent to those found in our previous telephone counseling intervention. There were high rates of satisfaction with both of the PFH-2 interventions.

Conclusions

The print and Web formats yielded equivalent levels of success to those found with our telephone-delivered intervention and are comparable to other Internet treatment studies. This study provides important options for survivorship programs that may not have resources for interpersonal forms of cessation counseling. Efforts to increase patient use of the interventions may result in higher cessation rates.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00588107","term_id":"NCT00588107"}}NCT00588107; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00588107","term_id":"NCT00588107"}}NCT00588107 (Archived by WebCite at http://www.webcitation.org/6K1gJtFEC).     

Cognitive Function and Sleep Related Breathing Disorders in a Healthy Elderly Population: the Synapse Study

Study Objectives:

Sleep related breathing disorders (SRBD) are risk factors for cognitive dysfunction in middle-aged subjects, but this association has not been observed in the elderly. We assess the impact of SRBD on cognitive performance in a large cohort of healthy elderly subjects.

Design:

Cross-sectional study examining the association between subjective memory test, neuropsychological battery testing and SRBD in the elderly.

Setting:

Community-based sample in home and research clinical settings.

Participants:

827 subjects, 58.5% women, aged 68 y at study entry, participated in the study. All were free of previously diagnosed SRBD, coronary heart disease, and neurological disorders, including stroke and dementia. Clinical interview, neurological assessment, polygraphy, and extensive cognitive testing were conducted for all participants.

Intervention:

N/A

Measurement and Results:

SRBD (apnea-hypopnea index [AHI] > 15 events/h) was diagnosed in 445 (53%) subjects, 167 (37%) of them with AHI > 30. Minimal daytime sleepiness was found in the group; 9.2% of the population had an Epworth Sleepiness Scale score > 10. No significant association was found between AHI, nocturnal hypoxemia, and cognitive scores. Comparison of mild vs severe cases showed a trend toward lower cognitive scores with AHI > 30, affecting delayed recall and Stroop test.

Conclusions:

The impact of undiagnosed SRBD on cognitive function appeared quite limited in a generally older healthy population, and only slightly affected severe cases. The implication of undiagnosed SRBD on the cognitive impairment in elderly subjects remains hypothetical and needs to be prospectively studied.

Clinical Trial Information:

Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea (SYNAPSE); Registration #{"type":"clinical-trial","attrs":{"text":"NCT 00766584","term_id":"NCT00766584"}}NCT 00766584 (This study is ongoing, but not recruiting participants.); URL - http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00766584","term_id":"NCT00766584"}}NCT00766584?term=NCT+00766584&rank=1

Citation:

Sforza E; Roche F; Thomas-Anterion C; Kerleroux J; Beauchet O; Celle S; Maudoux D; Pichot V; Laurent B; Barthélémy JC. Cognitive function and sleep related breathing disorders in a healthy elderly population: the synapse study. SLEEP 2010;33(4):515-521     

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).     

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)     

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).     

Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

Background

There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown.

Objective

The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention.

Methods

The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no).

Results

At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts.

Conclusions

No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change.

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)     

Sequential Allocation to Balance Prognostic Factors in a Psychiatric Clinical Trial

OBJECTIVE:

This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients.

METHOD:

Aitchison’s compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one.

RESULTS:

We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment.

CONCLUSION:

Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00466609","term_id":"NCT00466609"}}NCT00466609 and {"type":"clinical-trial","attrs":{"text":"NCT00680602","term_id":"NCT00680602"}}NCT00680602.     

Internet delivered support for tobacco control in dental practice: randomized controlled trial

Background

The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized.

Objective

To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings.

Methods

Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention.

Results

Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices’ mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK.

Conclusion

This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit.

Trial Registration

clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00627185","term_id":"NCT00627185"}}NCT00627185; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00627185","term_id":"NCT00627185"}}NCT00627185 (Archived by WebCite at http://www.webcitation.org/5c5Kugvzj)     

Longitudinal Accuracy of Web-Based Self-Reported Weights: Results From the Hopkins POWER Trial

Background

Websites and phone apps are increasingly used to track weights during weight loss interventions, yet the longitudinal accuracy of these self-reported weights is uncertain.

Objective

Our goal was to compare the longitudinal accuracy of self-reported weights entered online during the course of a randomized weight loss trial to measurements taken in the clinic. We aimed to determine if accuracy of self-reported weight is associated with weight loss and to determine the extent of misclassification in achieving 5% weight loss when using self-reported compared to clinic weights.

Methods

This study examined the accuracy of self-reported weights recorded online among intervention participants in the Hopkins Practice-Based Opportunities for Weight Reduction (POWER) trial, a randomized trial examining the effectiveness of two lifestyle-based weight loss interventions compared to a control group among obese adult patients with at least one cardiovascular risk factor. One treatment group was offered telephonic coaching and the other group was offered in-person individual coaching and group sessions. All intervention participants (n=277) received a digital scale and were asked to track their weight weekly on a study website. Research staff used a standard protocol to measure weight in the clinic. Differences (self-reported weight – clinic weight) indicate if self-report under (-) or over (+) estimated clinic weight using the self-reported weight that was closest in time to the clinic weight and was within a window ranging from the day of the clinic visit to 7 days before the 6-month (n=225) and 24-month (n=191) clinic visits. The absolute value of the differences (absolute difference) describes the overall accuracy.

Results

Underestimation of self-reported weights increased significantly from 6 months (mean -0.5kg, SD 1.0kg) to 24 months (mean -1.1kg, SD 2.0kg; P=.002). The average absolute difference also increased from 6 months (mean 0.7kg, SD 0.8kg) to 24 months (mean 1.3, SD 1.8kg; P<.001). Participants who achieved the study weight loss goal at 24 months (based on clinic weights) had lower absolute differences (P=.01) compared to those who did not meet this goal. At 24 months, there was 9% misclassification of weight loss goal success when using self-reported weight compared to clinic weight as an outcome. At 24 months, those with self-reported weights (n=191) had three times the weight loss compared to those (n=73) without self-reported weights (P<.001).

Conclusions

Underestimation of weight increased over time and was associated with less weight loss. In addition to intervention adherence, weight loss programs should emphasize accuracy in self-reporting.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT00783315","term_id":"NCT00783315"}}NCT00783315; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT00783315","term_id":"NCT00783315"}}NCT00783315 (Archived by WebCite at http://www.webcitation.org/6R4gDAK5K).