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Effects of a Collective Family-Based Mobile Health Intervention Called "SMARTFAMILY" on Promoting Physical Activity and Healthy Eating: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Numerous smartphone apps are targeting physical activity and healthy eating, but empirical evidence on their effectiveness for initialization and maintenance of behavior change, especially in children and adolescents, is still limited. OBJECTIVE:The aim of this study was to conceptualize a theory-based and evidence-based mHealth intervention called SMARTFAMILY (SF) that targets physical activity and healthy eating in a collective family-based setting. Subsequently, the app will be refined and re-evaluated to analyze additional effects of just-in-time adaptive interventions (JITAIs) and gamification features. METHODS:A smartphone app based on behavior change theories and behavior change techniques was developed and implemented and will be evaluated with family members individually and cooperatively (SF trial). Existing evidence and gained results were used to refine and will be used to re-evaluate the app (SF2.0 trial). Both trials are cluster randomized controlled trials with 3 measurement occasions. The intervention group uses the app for 3 consecutive weeks, whereas the control group receives no treatment. Baseline measurements (T0) and postintervention measurements (T1) include physical activity (ie, self-reported and accelerometry) and healthy eating measurements (ie, self-reported fruit and vegetable intake) as the primary outcomes. The secondary outcomes (ie, self-reported) are intrinsic motivation, behavior-specific self-efficacy, and the family health climate, complemented by an intentional measure in SF2.0. Four weeks following T1, a follow-up assessment (T2) is completed by the participants, consisting of all questionnaire items to assess the stability of the intervention effects. Mixed-method analysis of covariance will be used to calculate the primary intervention effects (ie, physical activity, fruit and vegetable intake) while controlling for covariates, including family health climate, behavior-specific self-efficacy, and intrinsic motivation. RESULTS:This study is funded by the German Federal Ministry of Education and Research and ethically approved by the Karlsruhe Institute of Technology. For both trials, it is hypothesized that the apps will positively influence physical activity and healthy eating in the whole family. Furthermore, SF2.0 is expected to produce stronger effects (ie, higher effect sizes) compared to SF. SF app development and piloting are completed. Data acquisition for the SF trial is terminated and discontinued due to the COVID-19 pandemic. SF2.0 app development and piloting are completed, while data acquisition is ongoing. Participant recruitment for the SF 2.0 trial started in February 2020. The results for SF are expected to be published in mid-2021, and the results of SF2.0 are expected to be published in mid-2022. CONCLUSIONS:In this study, it is hypothesized that targeting the whole family will facilitate behavior change at the individual level and the family level, as the implemented strategies address changes in daily family life. Furthermore, subsequent app development (SF2.0) with supplementary addition of motivation-enhancing features and a JITAI approach is expected to enhance positive intervention effects. TRIAL REGISTRATION:German Clinical Trials Register DRKS00010415; https://tinyurl.com/yyo87yyu. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/20534.

SUBMITTER: Wunsch K

PROVIDER: S-EPMC7688389 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Effects of a Collective Family-Based Mobile Health Intervention Called "SMARTFAMILY" on Promoting Physical Activity and Healthy Eating: Protocol for a Randomized Controlled Trial.

Wunsch Kathrin K Eckert Tobias T Fiedler Janis J Cleven Laura L Niermann Christina C Reiterer Harald H Renner Britta B Woll Alexander A

JMIR research protocols 20201111 11

<h4>Background</h4>Numerous smartphone apps are targeting physical activity and healthy eating, but empirical evidence on their effectiveness for initialization and maintenance of behavior change, especially in children and adolescents, is still limited.<h4>Objective</h4>The aim of this study was to conceptualize a theory-based and evidence-based mHealth intervention called SMARTFAMILY (SF) that targets physical activity and healthy eating in a collective family-based setting. Subsequently, the ...[more]

PMID: 33174849

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Project description:BackgroundSleep is instrumental for growth and development in children, making it critical to establish healthy sleep habits from the earliest years of life. Many kindergarteners (3-6 years) in China have inadequate and poor sleep, necessitating targeted interventions. This research protocol details the "Healthy Sleep" intervention that was designed to promote healthy sleep among kindergarteners in China.MethodsThe "Healthy Sleep" intervention will be family-based and will support parents as change agents. The development of the intervention is based on evidence regarding correlates of sleep in young children and guided by Bandura's social cognitive theory. A 12-month randomised controlled trial will be conducted to examine the efficacy of the intervention for promoting healthy sleep in Chinese kindergarteners and the intervention's effects on child development outcomes. A targeted sample of 160 kindergarteners and their parents will be recruited through social media. The intervention group (n = 80) will receive monthly webinars for one year that include multiple intervention components - including educational training, goal setting and planning, as well as follow-up support sessions. The control group (n = 80) will receive videos of the recorded educational sessions after the study end. For primary outcomes, child sleep behaviours will be examined using the Child Sleep Health Questionnaire. For secondary outcomes, communication, fine motor, gross motor, personal-social, and problem-solving development will be examined using the Ages and Stages Questionnaire; executive functions will be examined using the Head, Toes, Knees, and Shoulders Revised tasks. Potential intervention mediators and covariates will be measured using a parental questionnaire. Mixed models will be conducted.DiscussionThis intervention targets sleep behaviours among kindergarteners in China. It has the potential to inform programs to support parents in helping their child establish healthy sleep habits from the earliest years of life. The study will provide high-quality experimental evidence on sleep behaviours in relation to development outcomes in kindergarteners. This evidence will inform family-based strategies to optimise early childhood development and inform national and international updates of the sleep recommendations for young children.Trial registrationThe trial was registered prospectively at Chinese Clinical Trial Registry (ID: ChiCTR2300072105) on 2 June 2023.

Project description:BackgroundIn Lebanon, childhood obesity doubled during the past decade. Preventive measures should start early in life and Schools are considered an important environment to promote energy balance health behaviours. School-based programmes promoting healthy lifestyles are lacking. The purpose of this study was to evaluate the feasibility and effectiveness of a multicomponent school-based intervention to promote healthy eating and physical activity (and prevent obesity) with school children aged 9-11 years in Lebanon.MethodsThe intervention was developed based on the constructs of the Social Cognitive Theory and adapted to the culture of Lebanese and Arab populations. It consisted of three components: class curriculum, family involvement and food service. Eight schools were purposively selected from two communities of different socioeconomic status (SES) in Beirut and, within each school type, were matched on SES, religious sect profile, and then randomly assigned to either the intervention or control group. Anthropometric measurements and questionnaires on determinants of behavioural change, eating and physical activity habits were completed by the students in both groups at baseline and post intervention. Focus group interviews were conducted in intervention schools at the end of the study. Challenges encountered during the programme implementation were also identified, since Lebanon is considered a country with political unrest and no similar research projects were conducted in the area.ResultsStudents in the intervention group reported purchasing and consuming less chips and sweetened drinks post-intervention compared with controls (86% & 88% less respectively p < 0.001). Knowledge and self-efficacy scores increased for the intervention (+2.8 & +1.7 points respectively p < 0.001) but not for the control group. There was no difference in physical activity and screen time habits and no changes in BMI between groups at post intervention. Interview data from focus groups showed that the programme was generally well accepted. Limitations for better outcomes include the length of the programme and the school environment.Conclusion"Health-E-PALS" intervention is a promising innovative, theory-based, culturally sensitive intervention to promote healthy eating habits and physical activity in Lebanese school children with a potential to be scaled up, replicated and sustained.

Project description:BackgroundPeople of low socioeconomic position (SEP) are disproportionately affected by type 2 diabetes (T2D), partly due to unhealthy eating patterns that contribute to inadequate disease self-management and prognosis. Digital technologies have the potential to provide a suitable medium to facilitate diabetes education, support self-management, and address some of the barriers to healthy eating, such as lack of nutritional knowledge or shopping or cooking skills, in this target group.ObjectiveThis study aims to test the feasibility, appeal, and potential effectiveness of EatSmart, a 12-week, evidence-based, theoretically grounded, fully automated web-based and mobile-delivered healthy eating behavior change program to help disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management.MethodsEatSmart is a mixed methods (quantitative and qualitative) pre-post design pilot study. Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years will be recruited. Participants will complete self-reported baseline assessments of their basic demographic and clinical data, dietary intake, dietary self-efficacy, and barriers to healthy eating. They will be provided with login access to the EatSmart web program, which includes six progressive skill-based modules covering healthy eating planning; smart food budgeting and shopping; time-saving meal strategies, healthy cooking methods, modifying recipes; and a final reinforcement and summary module. Over the 3-month intervention, participants will also receive 3 text messages weekly, encouraging them to review goals, continue to engage with different components of the EatSmart web program, and eat healthily. Participants will undertake follow-up assessments directly following the intervention 3 months post baseline and again after a 6-month postintervention follow-up period (9 months post baseline). Feasibility will be evaluated using the number of participants recruited and retained and objective indicators of engagement with the website. Program appeal and potential effects on primary and secondary outcomes will be assessed via the same surveys used at baseline, with additional questions asking about experience with and perceptions of the program. In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal.ResultsThe EatSmart website has been developed, and all participants have viewed the modules as of May 2020. Results are expected to be submitted for publication in December 2020.ConclusionsThis study will provide data to address the currently limited evidence regarding whether disadvantaged populations with T2D may benefit from digitally delivered behavior change programs that facilitate eating healthily on a budget.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12619001111167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001111167.International registered report identifier (irrid)DERR1-10.2196/19488.

Project description:BACKGROUND:Technological interventions such as mobile apps, Web-based social networks, and wearable trackers have the potential to influence physical activity; yet, only a few studies have examined the efficacy of an intervention bundle combining these different technologies. OBJECTIVE:This study aimed to pilot test an intervention composed of a social networking mobile app, connected with a wearable tracker, and investigate its efficacy in improving physical activity, as well as explore participant engagement and the usability of the app. METHODS:This was a pre-post quasi-experimental study with 1 arm, where participants were subjected to the intervention for a 6-month period. The primary outcome measure was the difference in daily step count between baseline and 6 months. Secondary outcome measures included engagement with the intervention and system usability. Descriptive and inferential statistical tests were conducted; posthoc subgroup analyses were carried out for participants with different levels of steps at baseline, app usage, and social features usage. RESULTS:A total of 55 participants were enrolled in the study; the mean age was 23.6 years and 28 (51%) were female. There was a nonstatistically significant increase in the average daily step count between baseline and 6 months (mean change=14.5 steps/day, P=.98, 95% CI -1136.5 to 1107.5). Subgroup analysis comparing the higher and lower physical activity groups at baseline showed that the latter had a statistically significantly higher increase in their daily step count (group difference in mean change from baseline to 6 months=3025 steps per day, P=.008, 95% CI 837.9-5211.8). At 6 months, the retention rate was 82% (45/55); app usage decreased over time. The mean system usability score was 60.1 (SD 19.2). CONCLUSIONS:This study showed the preliminary efficacy of a mobile social networking intervention, integrated with a wearable tracker to promote physical activity, particularly for less physically active subgroups of the population. Future research should explore how to address challenges faced by physically inactive people to provide tailored advices. In addition, users' perspectives should be explored to shed light on factors that might influence their engagement with the intervention.

Project description:BackgroundPrevention of childhood obesity is a key approach to the primary prevention of noncommunicable diseases. Several models, based on the population health approach and aligned with ecological models, are used to design childhood obesity prevention programs around the world.ObjectiveThis study aims to introduce the design and evaluation plan of "Iran Healthy Start (IHS)/Aghazi Salem, Koodake Irani"-the customized Iranian version of Canadian Healthy Start/Départ Santé health promotion program-which is now being developed in Mashhad University of Medical Sciences (Mashhad, Iran) and focuses on improving physical activity and healthy eating among preschool children.MethodsWe will evaluate the intervention using a pilot randomized controlled design. The components of intervention include customized Decoda Web-based resources for children, an implementation guide for educators and managers, training and monitoring, communication and knowledge exchange, building partnership, and parent engagement. Outcomes include changes in anthropometry, physical activity level, nutritional risk status and dietary intake, and quality of life.ResultsThe project is funded by Mashhad University of Medical Sciences. The intervention was completed by the end of March 2018, and the analysis is currently under way. The first results of the IHS intervention program are expected to be submitted for publication in December 2018.ConclusionsThe double burden of malnutrition in early years children is a major health concern in developing countries. This justifies the need for health promotion programs that are specifically designed to target both overnutrition and undernutrition prevention. If the efficacy approved, the IHS could potentially be a comprehensive health promotion program for young children whose lifestyle behaviors can be improved toward a healthy future life in a nutrition transition setting.Trial registrationInternational Clinical Trials Registry Platform IRCT2016041927475N1; https://en.irct.ir/trial/22497.International registered report identifier (irrid)RR1-10.2196/11329.

Project description:BackgroundCardiac rehabilitation (CR) is an exercise-based program prescribed after cardiac events associated with improved physical, mental, and social functioning; however, many patients return to a sedentary lifestyle leading to deteriorating functional capacity after discharge from CR. Physical activity (PA) is critical to avoid recurrence of cardiac events and mortality and maintain functional capacity. Leveraging mobile health (mHealth) strategies to increase adherence to PA is a promising approach. Based on the social cognitive theory, we sought to determine whether mHealth strategies (Movn mobile app for self-monitoring, supportive push-through messages, and wearable activity tracker) would improve PA and functional capacity over 2 months.ObjectiveThe objectives of this pilot randomized controlled trial were to examine preliminary effects of an mHealth intervention on group differences in PA and functional capacity and group differences in depression and self-efficacy to maintain exercise after CR.MethodsDuring the final week of outpatient CR, patients were randomized 1:1 to the intervention group or usual care. The intervention group downloaded the Movn mobile app, received supportive push-through messages on motivation and educational messages related to cardiovascular disease (CVD) management 3 times per week, and wore a Charge 2 (Fitbit Inc) activity tracker to track step counts. Participants in the usual care group wore a pedometer and recorded their daily steps in a diary. Data from the 6-minute walk test (6MWT) and self-reported questionnaires were collected at baseline and 2 months.ResultsWe recruited 60 patients from 2 CR sites at a community hospital in Northern California. The mean age was 68.0 (SD 9.3) years, and 23% (14/60) were female; retention rate was 85% (51/60). Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02). There was no difference between groups for the 6MWT, depression, or self-efficacy to maintain exercise.ConclusionsThis intervention addresses a major public health initiative to examine the potential for mobile health strategies to promote PA in patients with CVD. Our technology-based pilot mHealth intervention provides promising results on a pragmatic and contemporary approach to promote PA by increasing daily step counts after completing CR.Trial registrationClinicalTrials.gov NCT03446313; https://clinicaltrials.gov/ct2/show/NCT03446313.

Project description:BACKGROUND:Regular participation in moderate-to-vigorous physical activity (MVPA) is important to manage obesity. Physical education (PE) is considered to play an important role in promoting lifelong participation in physical activity (PA) because it provides an existing network where cost-effective interventions can be implemented to produce sustainable change in health behavior. However, the association between compulsory school PA (e.g., PE lessons) and body composition levels has received mixed support in the literature. Therefore, the present study aimed to investigate whether a school-based intervention targeting salient PA benefits and barriers grounded on the theory of planned behavior would promote young people's participation in MVPA during leisure time and reduce body mass index (BMI) of overweight students. METHODS/DESIGN:A total of 171 students from 3 secondary schools in Singapore underwent the control condition followed by the intervention condition. Both the conditions consisted of PE lessons twice per week over 4 weeks. In the control condition, PE teachers encouraged students to participate in PA during leisure time without providing persuasive message. While in the intervention condition, PE teachers delivered persuasive messages that targeted the salient benefits and barriers associated with PA to the students at the last 5 to 10 min of each PE lesson. PA levels over a week were measured objectively with wrist-mounted GENEActiv Original accelerometers and subjectively with self-reporting questionnaires three times (Baseline, Post 1, and Post 2) in each condition. Student's self-reported PA level was measured using the Leisure-Time Physical Activity Participation Questionnaire and the International Physical Activity Questionnaire, and their attitudes, intentions, subjective norms and perceived behavior control towards leisure-time PA were measured with a questionnaire based on the theory of planned behavior. Furthermore, students' intention, determination and willingness to engage in leisure-time PA were compared with the other activity (e.g., doing homework, shopping). DISCUSSION:This study will provide the evidence on the effectiveness of a cost-effective school-based intervention on reducing BMI of overweight students through promoting sustained participation in leisure-time PA. It will also address methodological issues on the gaps between objective and subjective measures of PA. TRIAL REGISTRATION:This trial is registered with the ISRCTN registry (ISRCTN73786157, 26/10/2017, retrospectively registered).

Dataset Information

Effects of a Collective Family-Based Mobile Health Intervention Called "SMARTFAMILY" on Promoting Physical Activity and Healthy Eating: Protocol for a Randomized Controlled Trial.

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Effects of a Collective Family-Based Mobile Health Intervention Called "SMARTFAMILY" on Promoting Physical Activity and Healthy Eating: Protocol for a Randomized Controlled Trial.

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