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Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial.
Trials. 2020 Feb 03; 21(1):132.T

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.

Authors+Show Affiliations

BC Children's Hospital Research Institute, School of Population and Public Health, University of British Columbia, F508 - 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada. lmasse@bcchr.ubc.ca.BC Children's Hospital Research Institute, School of Population and Public Health, University of British Columbia, F508 - 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.Childhood Obesity Foundation, Robert HN Ho Research Centre, 771A - 2635 Laurel Street, VGH Hospital Campus, Vancouver, BC, V5 1M9, Canada.Childhood Obesity Foundation, Robert HN Ho Research Centre, 771A - 2635 Laurel Street, VGH Hospital Campus, Vancouver, BC, V5 1M9, Canada.Childhood Obesity Foundation, Robert HN Ho Research Centre, 771A - 2635 Laurel Street, VGH Hospital Campus, Vancouver, BC, V5 1M9, Canada.BC Children's Hospital Research Institute, School of Population and Public Health, University of British Columbia, F508 - 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.Division of Endocrinology, Department of Paediatrics, University of Toronto, The Hospital for Sick Children, 555 University Avenue, Toronto, ON,, M5G 1X8, Canada.Cumming School of Medicine, Department of Pediatrics, University of Calgary, Calgary, AB, T2N 4N1, Canada.Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON, K1H 8L1, Canada.Department of Pediatrics, Centre for Metabolism, Obesity and Diabetes Research, 1280 Main Street W., HSC-3A, Hamilton, ON, L8S 4K1,, Canada.Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, T6G 1C9, Canada.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

32014057

Citation

Mâsse, Louise C., et al. "Aim2Be mHealth Intervention for Children With Overweight and Obesity: Study Protocol for a Randomized Controlled Trial." Trials, vol. 21, no. 1, 2020, p. 132.
Mâsse LC, Vlaar J, Macdonald J, et al. Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. Trials. 2020;21(1):132.
Mâsse, L. C., Vlaar, J., Macdonald, J., Bradbury, J., Warshawski, T., Buckler, E. J., Hamilton, J., Ho, J., Buchholz, A., Morrison, K. M., & Ball, G. D. C. (2020). Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. Trials, 21(1), 132. https://doi.org/10.1186/s13063-020-4080-2
Mâsse LC, et al. Aim2Be mHealth Intervention for Children With Overweight and Obesity: Study Protocol for a Randomized Controlled Trial. Trials. 2020 Feb 3;21(1):132. PubMed PMID: 32014057.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial. AU - Mâsse,Louise C, AU - Vlaar,Janae, AU - Macdonald,Janice, AU - Bradbury,Jennifer, AU - Warshawski,Tom, AU - Buckler,E Jean, AU - Hamilton,Jill, AU - Ho,Josephine, AU - Buchholz,Annick, AU - Morrison,Katherine M, AU - Ball,Geoff D C, Y1 - 2020/02/03/ PY - 2019/09/05/received PY - 2020/01/16/accepted PY - 2020/2/5/entrez PY - 2020/2/6/pubmed PY - 2020/11/25/medline KW - Childhood obesity, Gamification, mHealth, Behavior change, Lifestyle intervention SP - 132 EP - 132 JF - Trials JO - Trials VL - 21 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/32014057/Aim2Be_mHealth_intervention_for_children_with_overweight_and_obesity:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4080-2 DB - PRIME DP - Unbound Medicine ER -