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Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyle behaviors (e.g., diet, physical activity, and sedentary behaviors). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has been presented as a viable alternative to in-person interventions for behavior change, especially with teens. PURPOSE:The primary aim of this study is to test the efficacy of Aim2Be, a gamified app based on behavior change theory with health coaching to improve weight outcomes (i.e., decrease in standardized body mass index (zBMI)) and lifestyle behaviors (i.e., improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among children 10- to 17-years old with overweight or obesity versus their peers randomized into a waitlist control condition. The secondary aims of this study are to 1) test whether supplementing the Aim2Be program with health coaching increases adherence and 2) examine the mediators and moderators of adherence to the Aim2Be intervention. METHODS:We will employ a randomized controlled trial design and recruit 200 child and parent dyads to participate in the study (2019-2020). Participants will be recruited from Canadian pediatric weight management clinics and through online advertisements. Child participants must be between the ages of 10 and 17?years, have overweight or obesity, be able to read English at least at a grade 5 level, and have a mobile phone or home computer with internet access. Following baseline data collection, participants will be randomized into intervention and waitlist control groups. Intervention participants will receive access to Aim2Be, with access to health coaching. After having their data collected for 3 months, the control group will gain access to Aim2Be, with no access to health coaching. Participants will control their frequency and duration of app usage to promote autonomy. DISCUSSION:Findings from this study will determine the efficacy of using Aim2Be in improving child weight outcomes and lifestyle behaviors and guide future mHealth interventions for pediatric weight management. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03651284. Registered 29 August 2018.

SUBMITTER: Masse LC

PROVIDER: S-EPMC6998843 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial.

Mâsse Louise C LC Vlaar Janae J Macdonald Janice J Bradbury Jennifer J Warshawski Tom T Buckler E Jean EJ Hamilton Jill J Ho Josephine J Buchholz Annick A Morrison Katherine M KM Ball Geoff D C GDC

Trials 20200203 1

<h4>Background</h4>The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyle behaviors (e.g., diet, physical activity, and sedentary behaviors). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has been presented as a viable a ...[more]

PMID: 32014057

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Project description:BackgroundThe World Federation of Obesity warns that the main health problem of the next decade will be childhood obesity. It is known that factors such as gestational obesity produce profound effects on fetal programming and are strong predictors of overweight and obesity in children. Therefore, establishing healthy eating behaviors during pregnancy is the key to the primary prevention of the intergenerational transmission of obesity. Mobile health (mHealth) programs are potentially more effective than face-to-face interventions, especially during a public health emergency such as the COVID-19 outbreak.ObjectiveThis study aims to evaluate the effectiveness of an mHealth intervention to reduce excessive weight gain in pregnant women who attend family health care centers.MethodsThe design of the intervention corresponds to a classic randomized clinical trial. The participants are pregnant women in the first trimester of pregnancy who live in urban and semiurban areas. Before starting the intervention, a survey will be applied to identify the barriers and facilitators perceived by pregnant women to adopt healthy eating behaviors. The dietary intake will be estimated in the same way. The intervention will last for 12 weeks and consists of sending messages through a multimedia messaging service with food education, addressing the 3 domains of learning (cognitive, affective, and psychomotor). Descriptive statistics will be used to analyze the demographic, socioeconomic, and obstetric characteristics of the respondents. The analysis strategy follows the intention-to-treat principle. Logistic regression analysis will be used to compare the intervention with routine care on maternal pregnancy outcome and perinatal outcome.ResultsThe recruitment of study participants began in May 2022 and will end in May 2023. Results include the effectiveness of the intervention in reducing the incidence of excessive gestational weight gain. We also will examine the maternal-fetal outcome as well as the barriers and facilitators that influence the weight gain of pregnant women.ConclusionsData from this effectiveness trial will determine whether mami-educ successfully reduces rates of excessive weight gain during pregnancy. If successful, the findings of this study will generate knowledge to design and implement personalized prevention strategies for gestational obesity that can be included in routine primary care.Trial registrationClinicalTrials.gov NCT05114174; https://clinicaltrials.gov/ct2/show/NCT05114174.International registered report identifier (irrid)DERR1-10.2196/44456.

Project description:Preventive and educational programs directed to former elite athletes in the areas of healthy living are required. This is particularly relevant as obesity and health-related problems are observed in retired athletes, especially in those whose current levels of physical activity are below the recommendations. During their sports career, elite athletes are supported by a multidisciplinary team; upon retirement, no support is provided for the transition to a different lifestyle. So far, no program has been implemented to promote sustained healthy lifestyle behaviors in the post-career transition and evidence is lacking for such an intervention. Firstly, we aim to determine if Champ4life, a 1-year lifestyle intervention targeting inactive former athletes with overweight and obesity, is effective for reducing total and abdominal fat. Secondly, our purpose is to assess the effectiveness of the intervention on the levels of physical activity and sedentary behavior, resting energy expenditure, cardio-metabolic markers, physical fitness, energy balance components, eating self-regulation markers, and quality of life over 12 months. Champ4life is an evidence- and theory-based program using a randomized control trial design (intervention vs. control group) that will be conducted on 94 inactive former elite athletes with overweight and obesity. The first four months of the Champ4Life program include a nutritional appointment and 12 weekly, 90-min sessions. Classroom sessions seek to provide participants with key information and a toolbox of behavior change techniques to initiate and sustain long-term lifestyle changes. Participants will undergo baseline, 4-month, and 12-month measurements of body composition (primary outcomes), resting energy expenditure, physical fitness, metabolic markers, energy balance related-markers, and quality of life (secondary outcome). This trial will provide evidence on the effectiveness of the Champ4life program, a pioneer lifestyle intervention for retired athletes, offering tools for sustained changes in physical activity, sedentary behavior and diet, aiming to improve body composition and overall health-related markers.

Project description:BackgroundPregnant patients with overweight or obesity are at high risk for perinatal complications. Excess gestational weight gain (GWG) further exacerbates this risk. Mobile health (mHealth) lifestyle interventions that leverage technology to facilitate self-monitoring and provide just-in-time feedback may motivate behavior change to reduce excess GWG, reduce intervention costs, and increase scalability by improving access.ObjectiveThis study aimed to test the acceptability and feasibility of a pilot mHealth lifestyle intervention for pregnant patients with overweight or obesity to promote moderate intensity physical activity (PA), encourage guideline-concordant GWG, and inform the design of a larger pragmatic cluster randomized controlled trial.MethodsWe conducted a mixed methods acceptability and feasibility randomized controlled trial among pregnant patients with a prepregnancy BMI of 25 to 40 kg/m2. Patients with singletons at 8 to 15 weeks of gestation who were aged ≥21 years and had Wi-Fi access were recruited via email from 2 clinics within Kaiser Permanente Northern California and randomized to receive usual prenatal care or an mHealth lifestyle intervention. Participants in the intervention arm received wireless scales, access to an intervention website, activity trackers to receive automated feedback on weight gain and activity goals, and monthly calls from a lifestyle coach. Surveys and focus groups with intervention participants assessed intervention satisfaction and ways to improve the intervention. PA outcomes were self-assessed using the Pregnancy Physical Activity Questionnaire, and GWG was assessed using electronic health record data for both arms.ResultsOverall, 33 patients were randomly assigned to the intervention arm, and 35 patients were randomly assigned to the usual care arm. All participants in the intervention arm weighed themselves at least once a week, compared with 20% (7/35) of the participants in the usual care arm. Participants in the intervention arm wore the activity tracker 6.4 days per week and weighed themselves 5.3 times per week, and 88% (29/33) of them rated the program "good to excellent." Focus groups found that participants desired more nutrition-related support to help them manage GWG and would have preferred an app instead of a website. Participants in the intervention arm had a 23.46 metabolic equivalent of task hours greater change in total PA per week and a 247.2-minute greater change in moderate intensity PA per week in unadjusted models, but these effects were attenuated in adjusted models (change in total PA: 15.55 metabolic equivalent of task hours per week; change in moderate intensity PA: 199.6 minutes per week). We found no difference in total GWG (mean difference 1.14 kg) compared with usual care.ConclusionsThe pilot mHealth lifestyle intervention was feasible, highly acceptable, and promoted self-monitoring. Refined interventions are needed to effectively affect PA and GWG among pregnant patients with overweight or obesity.Trial registrationClinicalTrials.gov NCT03936283; https://clinicaltrials.gov/ct2/show/NCT03936283.

Project description:BackgroundCancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors do not reach the recommended physical activity levels and have overweight. This has implications for both physical and psychological health, including an increased risk of subsequent and secondary cancers. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology in improving health outcomes in cancer survivors with overweight or obesity.ObjectiveThis study aims to investigate whether a personalized mHealth behavior change intervention improves physical and psychological health outcomes in cancer survivors with overweight or obesity.MethodsA sample of 123 cancer survivors (BMI≥25 kg/m2) was randomly assigned to the standard care control (n=61) or intervention (n=62) condition. Group allocation was unblinded. The intervention group attended a 4-hour tailored lifestyle education and information session with physiotherapists, a dietician, and a clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through SMS text messaging contact with the research team). Direct measures of physical activity were collected using a Fitbit accelerometer. Data on anthropometric, functional exercise capacity, dietary behavior, and psychological measures were collected at face-to-face assessments in a single hospital site at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up).ResultsThe rate of attrition was 21% (13/61) for the control condition and 14% (9/62) for the intervention condition. Using intent-to-treat analysis, significant reductions in BMI (F2,242=4.149; P=.02; ηp2=0.033) and waist circumference (F2,242=3.342; P=.04; ηp2=0.027) were observed in the intervention group. Over the 24-week study, BMI was reduced by 0.52 in the intervention condition, relative to a nonsignificant reduction of 0.11 in the control arm. Waist circumference was reduced by 3.02 cm in the intervention condition relative to 1.82 cm in the control condition. Physical activity level was significantly higher in the intervention group on 8 of the 12 weeks of the intervention phase and on 5 of the 12 weeks of the follow-up period, accounting for up to 2500 additional steps per day (mean 2032, SD 270).ConclusionsThe results demonstrate that for cancer survivors with a BMI≥25 kg/m2, lifestyle education and personalized goal setting using mobile technology can yield significant changes in clinically relevant health indicators. Further research is needed to elucidate the mechanisms of behavior change and explore the capacity for mHealth interventions to improve broader health and well-being outcomes in the growing population of cancer survivors.Trial registrationISRCTN Registry ISRCTN18676721; https://www.isrctn.com/ISRCTN18676721.International registered report identifier (irrid)RR2-10.2196/13214.

Project description:BACKGROUND:To date, few mobile health (mHealth) interventions aimed at changing lifestyle behaviors have measured long term effectiveness. At the 6-month follow-up the MINISTOP trial found a statistically significant intervention effect for a composite score comprised of fat mass index (FMI) as well as dietary and physical activity variables; however, no intervention effect was observed for FMI. Therefore, the aim of this study was to investigate if the MINISTOP intervention 12-months after baseline measurements: (i) improved FMI and (ii) had a maintained effect on a composite score comprised of FMI and dietary and physical activity variables. METHODS:A two-arm parallel randomized controlled trial was conducted in 315 healthy 4.5 year old children between January 2014 and October 2015. Parents' of the participating children either received the MINISTOP intervention or a basic pamphlet on dietary and physical activity behaviors (control group). After 6 months, participants did not have access to the intervention content and were measured again 6 months later (i.e. the 12-month follow-up). The Wilcoxon rank-sum test was then used to examine differences between the groups. RESULTS:At the 12-month follow-up, no statistically significant difference was observed between the intervention and control groups for FMI (p?=?0.57) and no maintained effect for the change in composite score was observed (mean?±?standard deviation for the intervention and control group: +?0.53?±?1.49 units and?+?0.35?±?1.27 units respectively, p?=?0.25 between groups). CONCLUSIONS:The intervention effect observed at the 6-month follow-up on the composite score was not maintained at the 12-month follow-up, with no effect on FMI being observed at either follow-up. Future studies using mHealth are needed to investigate how changes in obesity related markers in young children can be maintained over longer time periods. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02021786 ; 20 Dec 2013).

Project description:BackgroundHigh gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain.ObjectiveThe primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity.MethodsThe Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain.ResultsRecruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018.ConclusionsThis is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application.Registered report identifierRR1-10.2196/9220.

Project description:BackgroundMany children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice.Methods and designThis paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured.DiscussionTwenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.

Project description:BACKGROUND:Young sexual minority men in the United States have a high incidence rate of HIV infection. Early intervention among this group, that is timed to precede or coincide with sexual initiation, is of critical importance to prevent HIV infection. Despite this, there are very few published randomized controlled efficacy trials testing interventions to reduce sexual vulnerability for HIV acquisition among racially/ethnically diverse, very young, sexual minority men (aged ≤18 years). This paper describes the design of a mobile app-based intervention trial to reduce sexual risk for HIV acquisition and promote health protection in this group. METHODS:This study is a randomized controlled trial of an mHealth-based HIV prevention intervention, MyPEEPS Mobile, among diverse sexual minority cisgender young men, aged 13-18 years. The mobile intervention was adapted from a prior group-based intervention curriculum with evidence of efficacy, designed to be specific to the risk contexts and realities of young sexual minority men, and to include psychoeducational and skill-building components with interactive games and activities. Participants are recruited locally within four regional hubs (Birmingham, AL, Chicago, IL, New York City, NY, Seattle, WA) and nationwide via the Internet, enrolled in-person or remotely (via videoconference), and randomized (1:1) to either the MyPEEPS Mobile intervention or delayed intervention condition. Post-hoc stratification by age, race/ethnicity, and urban/suburban vs. rural statuses is used to ensure diversity in the sample. The primary outcomes are number of male anal sex partners and frequency of sexual acts with male partners (with and without condoms), sex under the influence of substances, and uptake of pre-and post-exposure prophylaxis, as well as testing for HIV and other sexually transmitted infections at 3-, 6- and 9-month follow-up. DISCUSSION:Behavioral interventions for very young sexual minority men are needed to prevent sexual risk early in their sexual development and maturation. This study will provide evidence to determine feasibility and efficacy of a mobile app-based HIV prevention intervention to reduce sexual risk among this very young group. TRIAL REGISTRATION:ClinicalTrials.gov number, NCT03167606, registered May 30, 2017.

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Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial.

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Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial.

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