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Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

ABSTRACT: To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI???25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P?=?0.003), but not at 12 and 24 months.Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.

SUBMITTER: Svetkey LP

PROVIDER: S-EPMC4636032 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

Svetkey Laura P LP Batch Bryan C BC Lin Pao-Hwa PH Intille Stephen S SS Corsino Leonor L Tyson Crystal C CC Bosworth Hayden B HB Grambow Steven C SC Voils Corrine C Loria Catherine C Gallis John A JA Schwager Jenifer J Bennett Gary G GG

Obesity (Silver Spring, Md.) 20151101 11

<h4>Objective</h4>To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.<h4>Methods</h4>Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.<h4>Resu ...[more]

PMID: 26530929

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Project description:BACKGROUND:Providing financial incentives has gained popularity as a strategy to promote weight loss, but questions remain about how best to utilize them. A promising mobile health strategy provides users with near-real-time financial incentives based on both the process of weight loss (behavioral modification) and actual weight loss. To maximize the impact of this strategy, a methodology is needed to close the gap between the desired behavior and the financial incentive. Leveraging mobile health tools-such as mobile phone apps, cellular body weight scales that transmit data to physicians and researchers, and text messaging for instructions and encouragement-has the potential to close this gap. OBJECTIVE:This study aimed to describe the development of an innovative technology-based solution and lessons learned from a feasibility trial-Log2Lose-that encouraged individuals to lose weight by providing near-real-time financial incentives for weight loss and/or dietary self-monitoring. METHODS:We recruited participants (N=96) with a body mass index greater than or equal to 30 kg/m2 for a 24-week weight loss trial. Participants received a behavioral intervention of biweekly, in-person group sessions and were instructed to log a minimum number of daily calories in MyFitnessPal and to step on the BodyTrace cellular scale at least twice per week. In a 2×2 design, participants were randomized into 4 groups to receive financial incentives for the following: (group 1) weekly weight loss and dietary self-monitoring, (group 2) dietary self-monitoring only, (group 3) weekly weight loss only, or (group 4) no financial incentives. Diet and weight data from the devices were obtained through application programming interfaces. Each week, we applied algorithms to participants' data to determine whether they qualified for a monetary incentive (groups 1-3). A text message notified these participants of whether they met weight loss and/or self-monitoring requirements to earn an incentive and the amount they earned or would have earned. The money was uploaded to a debit card. RESULTS:Our custom-engineered software platform analyzed data from multiple sources, collated and processed the data to send appropriate text messages automatically, and informed study staff of the appropriate incentives. We present lessons learned from the development of the software system and challenges encountered with technology, data transmission, and participants (eg, lost connections or delayed communication). CONCLUSIONS:With consistent and constant validation checks and a robust beta test run, the process of analyzing data and determining eligibility for weekly incentives can be mostly automated. We were able to accomplish this project within an academic health system, which required significant security and privacy safeguards. Our success demonstrates how this methodology of automated feedback loops can provide health interventions via mobile technology. TRIAL REGISTRATION:ClinicalTrials.gov NCT02691260; https://clinicaltrials.gov/ct2/show/NCT02691260.

Project description:BackgroundYouth homelessness is a substantial issue, and many youths experiencing homelessness have mental health issues as both a cause and consequence of homelessness. These youths face many barriers to receiving traditional mental health services, and as a result, only a few youths experiencing homelessness receive any form of mental health care.ObjectiveThis project aimed to develop and determine the feasibility and acceptability of engaging young adults (ie, individuals aged 18-24 years) experiencing homelessness in a remotely delivered mental health intervention. This intervention provided brief emotional support and coping skills, drawing from cognitive behavioral principles as an introduction into psychosocial support. The intervention was piloted in a homeless shelter network.MethodsA total of 35 young adults experiencing homelessness participated in a single-arm feasibility pilot trial. Participants received a mobile phone, a service and data plan, and 1 month of support from a coach consisting of up to 3 brief phone sessions, text messaging, and mobile mental health apps. We evaluated feasibility by looking at completion of sessions as well as the overall program and acceptability with satisfaction ratings. We also collected clinical symptoms at baseline and the end of the 1-month support period. We used validity items to identify participants who might be responding inappropriately and thus only report satisfaction ratings and clinical outcomes from valid responses.ResultsMost participants (20/35, 57%) completed all 3 of their phone sessions, with an average of 2.09 sessions (SD 1.22) completed by each participant. Participants sent an average of 15.06 text messages (SD 12.62) and received an average of 19.34 messages (SD 12.70). We found higher rates of satisfaction among the participants with valid responses, with 100% (23/23) of such participants indicating that they would recommend participation to someone else and 52% (12/23) reporting that they were very or extremely satisfied with their participation. We found very little change from pre- to posttreatment on measures of depression (d=0.27), post-traumatic stress disorder (d=0.17), and emotion regulation (d=0.10).ConclusionsThis study demonstrated that it was feasible to engage homeless young adults in mental health services in this technology-based intervention with high rates of satisfaction. We did not find changes in clinical outcomes; however, we had a small sample size and a brief intervention. Technology might be an important avenue to reach young adults experiencing homelessness, but additional work could explore proper interventions to deliver with such a platform.Trial registrationClinicalTrials.gov NCT03620682; https://clinicaltrials.gov/ct2/show/NCT03620682.

Project description:One-third of US adults, 86 million people, have prediabetes. Two-thirds of adults are overweight or obese and at risk for diabetes. Effective and affordable interventions are needed that can reach these 86 million, and others at high risk, to reduce their progression to diagnosed diabetes.The aim was to evaluate the effectiveness of a fully automated algorithm-driven behavioral intervention for diabetes prevention, Alive-PD, delivered via the Web, Internet, mobile phone, and automated phone calls.Alive-PD provided tailored behavioral support for improvements in physical activity, eating habits, and factors such as weight loss, stress, and sleep. Weekly emails suggested small-step goals and linked to an individual Web page with tools for tracking, coaching, social support through virtual teams, competition, and health information. A mobile phone app and automated phone calls provided further support. The trial randomly assigned 339 persons to the Alive-PD intervention (n=163) or a 6-month wait-list usual-care control group (n=176). Participants were eligible if either fasting glucose or glycated hemoglobin A1c (HbA1c) was in the prediabetic range. Primary outcome measures were changes in fasting glucose and HbA1c at 6 months. Secondary outcome measures included clinic-measured changes in body weight, body mass index (BMI), waist circumference, triglyceride/high-density lipoprotein cholesterol (TG/HDL) ratio, and Framingham diabetes risk score. Analysis was by intention-to-treat.Participants' mean age was 55 (SD 8.9) years, mean BMI was 31.2 (SD 4.4) kg/m(2), and 68.7% (233/339) were male. Mean fasting glucose was in the prediabetic range (mean 109.9, SD 8.4 mg/dL), whereas the mean HbA1c was 5.6% (SD 0.3), in the normal range. In intention-to-treat analyses, Alive-PD participants achieved significantly greater reductions than controls in fasting glucose (mean -7.36 mg/dL, 95% CI -7.85 to -6.87 vs mean -2.19, 95% CI -2.64 to -1.73, P<.001), HbA1c (mean -0.26%, 95% CI -0.27 to -0.24 vs mean -0.18%, 95% CI -0.19 to -0.16, P<.001), and body weight (mean -3.26 kg, 95% CI -3.26 to -3.25 vs mean -1.26 kg, 95% CI -1.27 to -1.26, P<.001). Reductions in BMI, waist circumference, and TG/HDL were also significantly greater in Alive-PD participants than in the control group. At 6 months, the Alive-PD group reduced their Framingham 8-year diabetes risk from 16% to 11%, significantly more than the control group (P<.001). Participation and retention was good; intervention participants interacted with the program a median of 17 (IQR 14) of 24 weeks and 71.1% (116/163) were still interacting with the program in month 6.Alive-PD improved glycemic control, body weight, BMI, waist circumference, TG/HDL ratio, and diabetes risk. As a fully automated system, the program has high potential for scalability and could potentially reach many of the 86 million US adults who have prediabetes as well as other at-risk groups.Clinicaltrials.gov NCT01479062; https://clinicaltrials.gov/ct2/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6bt4V20NR).

Project description:BackgroundFeedback for participants' self-monitoring is a crucial and costly component of technology-based weight loss interventions. Detailed examination of interventionist time when reviewing and providing feedback for online self-monitoring data is lacking.ObjectiveThe aim of this study was to longitudinally examine the time counselors spent providing feedback on participant self-monitoring data (ie, diet, physical activity, weight) in a 12-month technology-based weight loss intervention. We hypothesized that counselors would compose feedback for participants more quickly over time.MethodsThe time the lay counselors (N=10) spent reviewing self-monitoring records and providing feedback to participants via email was longitudinally examined for all counselors across the three years of study implementation. Descriptives were observed for counselor feedback duration across counselors by 12 annual quarters (ie, 3-month periods). Differences in overall duration times by each consecutive annual quarter were analyzed using Wilcoxon-Mann-Whitney tests.ResultsThere was a decrease in counselor feedback duration from the first to second quarter (mean 53 to 46 minutes; P<.001), and from the second to third (mean 46 to 30 minutes; P<.001). A trend suggested a decrease from the third to fourth quarter (mean 30 to 26 minutes; P=.053), but no changes were found in subsequent quarters. Consistent with the hypothesis, counselors may be increasing their efficiency in providing feedback; across 12 months, counselors spent less time reviewing participant self-monitoring and composing feedback (decreasing from mean 53 to 26 minutes).ConclusionsCounselors used increasingly less time to review online self-monitoring data and compose feedback after the initial 9 months of study implementation. Results inform counselor costs for future technology-based behavioral weight loss interventions. For example, regardless of increasing counselor efficiency, 25-30 minutes per feedback message is a high cost for interventions. One possibility for reducing costs would be generating computer-automated feedback.Trial registrationClinicalTrials.gov NCT02063178; https://clinicaltrials.gov/ct2/show/NCT02063178.

Project description:BackgroundThere is large variance in weight loss outcomes of digital behavior change interventions (DBCIs). It has been suggested that different patterns of engagement in the program could be responsible for this variance in outcomes. Previous studies have found that the amount of engagement on DBCIs, such as the number of meals logged or articles read, is positively associated with weight loss.ObjectiveThis retrospective study extends previous research by observing how important weight loss outcomes (high weight loss: 10% or greater body weight loss; moderate weight loss: between 5% to 10%; stable weight: 0 plus or minus 1%) are associated with engagement on a publicly available mobile DBCI (Noom) from 9 to 52 weeks.MethodsEngagement and weight data for eligible participants (N=11,252) were extracted from the Noom database. Engagement measures included the number of articles read, meals logged, steps recorded, messages to coach, exercise logged, weigh-ins, and days with 1 meal logged per week. Weight was self-reported on the program. Multiple linear regressions examined how weight loss outcome (moderate and high vs stable) was associated with each engagement measure across 3 study time periods: 9-16 weeks, 17-32 weeks, and 33-52 weeks.ResultsAt 9-16 weeks, among the 11,252 participants, 2594 (23.05%) had stable weight, 6440 (57.23%) had moderate weight loss, and 2218 (19.71%) had high weight loss. By 33-52 weeks, 525 (18.21%) had stable weight, 1214 (42.11%) had moderate weight loss, and 1144 (39.68%) had high weight loss. Regression results showed that moderate weight loss and high weight loss outcomes were associated with all engagement measures to a significantly greater degree than was stable weight (all P values <.001). These differences held across all time periods with the exception of exercise for the moderate weight loss category at 1 time period of 33-52 weeks. Exercise logging increased from 9 to 52 weeks regardless of the weight loss group.ConclusionsOur results suggest that these clinically important weight loss outcomes are related to the number of articles read, meals logged, steps recorded, messages to coach, exercise logged, weigh-ins, and days with 1 meal logged per week both in the short-term and long-term (ie, 1 year) on Noom. This provides valuable data on engagement patterns over time on a self-directed mobile DBCI, can help inform how interventions tailor recommendations for engagement depending on how much weight individuals have lost, and raises important questions for future research on engagement in DBCIs.

Project description:BACKGROUND:In the United States, approximately one-third of adolescents are now overweight or obese, and one in six is obese. This financial cost and the larger nonfinancial costs of obesity make obesity prevention and management for adolescents imperative for the health of the nation. However, primary care visits are typically brief, and primary care providers may lack adequate resources to help overweight or obese adolescents to manage weight issues. To augment the efficacy of primary care visits for adolescent weight management, mobile phone technology can be used as an adjunct treatment that provides additional opportunities for encouraging improvement in lifestyle, attainment, and maintenance of healthy weight. OBJECTIVE:The purposes of this study were to (1) measure effects of an innovative mobile phone technology-based intervention for overweight and obese adolescents and to (2) examine the intervention's feasibility for use in primary care clinics. METHODS:The mobile phone-based intervention had three components: use of the Fitbit Flex, participation in an online educational program, and receipt of biweekly text messages during the maintenance phase. A randomized controlled study design was utilized. Data regarding anthropometrics (body mass index [BMI] and waist-to-hip ratio), blood pressure, levels of physical and sedentary activity, diet, and self-efficacy regarding physical activity and diet were collected at baseline and at 3 and 6 months after the baseline assessment. RESULTS:A total of 40 adolescents participated in the study. At the 6-month follow-up visit, compared to participants in the control group, the mobile phone-based intervention participants had significant improvement in BMI (z=-4.37, P=.001), diastolic blood pressure (z=-3.23, P=.001), physical activity days per week (z=2.58, P=.01), TV and computer time (z=-3.34, P=.001), servings of fruits and vegetables per day (z=2.74, P=.006), servings of soda and sweetened drinks (z=-3.19, P=.001), physical activity self-efficacy (z=2.75, P=.006), and dietary self-efficacy (z=5.05, P=.001). Medium to large effect sizes were found in these outcome variables. CONCLUSIONS:The use of mobile technologies may offer a practical, reliable adjunct to weight management for overweight and obese adolescents in busy primary care clinics serving adolescents. TRIAL REGISTRATION:Clinicaltrials.gov NCT 01693250; https://clinicaltrials.gov/ct2/show/NCT01693250? term=Adolescent+ obesity+AND+mhealth&rank=5 (Archived by WebCite at ).

Project description:IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men's access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40-69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594-17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

Project description:BACKGROUND:Heavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown. METHODS/DESIGN:We will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (?4 drinks for women; ?5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months. DISCUSSION:This study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change. TRIAL REGISTRATION:Clinicaltrials.gov NCT01688245.

Dataset Information

Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

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Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

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