Patrick Timpel1, Fernando Henpin Yue Cesena2, Christiane da Silva Costa3, Matheus Dorigatti Soldatelli4, Emanuel Gois5, Eduardo Castrillon6, Lina Johana Jaime Díaz7, Gabriela M Repetto8, Fanah Hagos9, Raul E Castillo Yermenos10, Kevin Pacheco-Barrios11, Wafaa Musallam12, Zilda Braid13, Nesreen Khidir14, Marcela Romo Guardado15, Roberta Muriel Longo Roepke16. 1. Prevention and Care of Diabetes Mellitus, Department of Medicine III, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Fetscherstrasse 74, Dresden 01307, Germany. 2. Hospital Israelita Albert Einstein, São Paulo, SP, Brazil. 3. Brazilian Health Regulatory Agency, Anvisa, Brazil. 4. Department of Radiology, Hospital das Clínicas de Porto Alegre, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. 5. Department of Surgery, State University of Londrina, Brazil; Pontifical University of Parana, Brazil. 6. Departamento de Clínicas Médicas, Pontificia Universidad Javeriana de Cali, Cali, Colombia. 7. Clínica Universidad de la Sabana, Bogotá, Colombia. 8. Center for Genetics and Genomics, Facultad de Medicina, Clínica Alemana Universidad del Desarrollo, Santiago, Chile. 9. Department of Palliative and Hospice Care Liaison for CD at Emerson Hospital, Concord, MA, USA. 10. Centro de Investigaciones Biomédicas y Clínicas 'Dr Sergio Bencosme' (CINBIOCLI), Santiago de Los Caballeros, República Dominicana. 11. Neuroscience and Behavior Laboratory, Universidad Peruana Cayetano Heredia, Lima, Peru. 12. Family Medicine Specialist, Primary Health Care Corporation, Doha, Qatar. 13. Departament of Pediatrics, Ribeirão Preto Medical School - University of São Paulo, Ribeirão Preto, São Paulo, SP, Brazil. 14. Bariatric and Metabolic Surgery, Hamad Medical Corporation, Doha, Qatar. 15. Mental Health Hospital of Tijuana, Tijuana, Mexico. 16. Disciplina de Emergencias Clínicas, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil.
Abstract
BACKGROUND: Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. METHOD: The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. DISCUSSION: The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement.
BACKGROUND: Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. METHOD: The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. DISCUSSION: The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in line with the Consolidated Standards of Reporting Trials statement.
Entities:
Keywords:
adolescents; clinical trial; gamification; obesity; overweight; smartphone application; study protocol; weight loss
Authors: Cynthia L Ogden; Margaret D Carroll; Hannah G Lawman; Cheryl D Fryar; Deanna Kruszon-Moran; Brian K Kit; Katherine M Flegal Journal: JAMA Date: 2016-06-07 Impact factor: 56.272
Authors: Olga van der Baan-Slootweg; Marc A Benninga; Anita Beelen; Job van der Palen; Christine Tamminga-Smeulders; Jan G P Tijssen; Wim M C van Aalderen Journal: JAMA Pediatr Date: 2014-09 Impact factor: 16.193
Authors: Robert I Berkowitz; Marsha D Marcus; Barbara J Anderson; Linda Delahanty; Nisha Grover; Andrea Kriska; Lori Laffel; Amy Syme; Elizabeth Venditti; Dorothy J Van Buren; Denise E Wilfley; Patrice Yasuda; Kathryn Hirst Journal: Pediatr Diabetes Date: 2017-06-30 Impact factor: 4.866
Authors: Melissa A Kalarchian; Michele D Levine; Silva A Arslanian; Linda J Ewing; Patricia R Houck; Yu Cheng; Rebecca M Ringham; Carrie A Sheets; Marsha D Marcus Journal: Pediatrics Date: 2009-09-28 Impact factor: 7.124
Authors: Mercedes de Onis; Adelheid W Onyango; Elaine Borghi; Amani Siyam; Chizuru Nishida; Jonathan Siekmann Journal: Bull World Health Organ Date: 2007-09 Impact factor: 9.408
Authors: Maged N Kamel Boulos; Shauna Gammon; Mavis C Dixon; Sandra M MacRury; Michael J Fergusson; Francisco Miranda Rodrigues; Telmo Mourinho Baptista; Stephen P Yang Journal: JMIR Serious Games Date: 2015-03-18 Impact factor: 4.143
Authors: Kelly R Theim; Meghan M Sinton; Andrea B Goldschmidt; Dorothy J Van Buren; Angela C Doyle; Brian E Saelens; Richard I Stein; Leonard H Epstein; Denise E Wilfley Journal: Obesity (Silver Spring) Date: 2013-02 Impact factor: 5.002
Authors: Maxi Pia Bretschneider; Jan Klásek; Martina Karbanová; Patrick Timpel; Sandra Herrmann; Peter E H Schwarz Journal: Nutrients Date: 2022-04-26 Impact factor: 6.706
Authors: Shannon B Juengst; Lauren Terhorst; Andrew Nabasny; Tracey Wallace; Jennifer A Weaver; Candice L Osborne; Suzanne Perea Burns; Brittany Wright; Pey-Shan Wen; Chung-Lin Novelle Kew; John Morris Journal: Int J Environ Res Public Health Date: 2021-02-23 Impact factor: 3.390