Frontiers in endocrinology · 2026
Scale-up of the Diactive-1 mHealth program integrating tailored resistance training as an educational strategy for self-management in children and adolescents with type 1 diabetes: protocol for an 11-hospital multicenter randomized controlled trial.
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Sánchez-Arlegui Amaia, Muñoz-Pardeza Jacinto, Hormazábal-Aguayo Ignacio, Abio-Abero Sonia, Bertholt-Zuber María Laura, Alonso-Rubio Pablo, Burillo-Sánchez Elisabet, Chueca-Guindulain María J, Cifuentes-Zamalloa Claudia, Congost-Marín Sofía, Díez-López Ignacio, Ferrer-Lozano Marta, García-Navas Patricia, González-García Lara Gloria, Huidobro-Fernández Belén, Lalaguna-Mallada Paula, Llorente-Cereza María Teresa, Maeso-Mendez Sandra, Riaño-Galán Isolina, Ruiz-Del Campo María, Salcedo Fresneda Oihane, Vara-Callau Marta, Vela-Desojo Amaia, Ezzatvar Yasmin, García-Hermoso Antonio
Аннотация
INTRODUCTION: Physical activity is strongly recommended for youth with type 1 diabetes, yet many children and adolescents do not meet current exercise guidelines, partly because of fear of hypoglycemia. Resistance training may offer metabolic and musculoskeletal benefits, but its implementation in routine pediatric diabetes care remains limited. Diactive-1 is an mHealth program designed to deliver tailored resistance-training sessions combined with glucose-management educational support. This multicenter trial aims to evaluate the effectiveness of Diactive-1 (v2.0) in improving hangrip strength in children and adolescents with type 1 diabetes.
METHODS: This study is a 12-week, parallel-group, multicenter randomized controlled trial conducted across 11 Spanish pediatric endocrinology units. The target sample size is 158 children and adolescents aged 10-18 years with type 1 diabetes, with 79 participants allocated to each group. Participants will be randomized to either the Diactive-1 intervention or usual clinical care. The intervention group will use the Diactive-1 (v2.0) app, which provides individualized resistance-training programs, glucose-related educational prompts, safety thresholds for exercise, and engagement strategies such as gamification. The primary outcome will be the change in age- and sex-standardized handgrip strength z-score from baseline to 12 weeks. Secondary outcomes will include glycemic stability, insulin requirements, cardiometabolic markers, physical literacy, quality of life, psychological well-being, app usability, and intervention engagement. Analyses will follow the intention-to-treat principle using mixed-effects models.
EXPECTED OUTCOMES AND DISCUSSION: This trial will assess whether a scalable mHealth-supported resistance-training program can improve muscular strength and support diabetes self-management in routine pediatric care. By testing Diactive-1 across multiple hospitals and real-world settings, the study will provide evidence on the external validity, feasibility, and potential clinical integration of digitally supported exercise education for youth with type 1 diabetes.
ETHICS AND DISSEMINATION: Ethical approval was granted by the Research Ethics Committee for Medicinal Products of the Government of Navarra. Written informed consent will be obtained from parents or legal guardians, with age-appropriate assent from minors. Findings will be disseminated through scientific conferences, peer-reviewed publications, and summaries shared with participating families.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT07290868, identifier NCT07290868.
METHODS: This study is a 12-week, parallel-group, multicenter randomized controlled trial conducted across 11 Spanish pediatric endocrinology units. The target sample size is 158 children and adolescents aged 10-18 years with type 1 diabetes, with 79 participants allocated to each group. Participants will be randomized to either the Diactive-1 intervention or usual clinical care. The intervention group will use the Diactive-1 (v2.0) app, which provides individualized resistance-training programs, glucose-related educational prompts, safety thresholds for exercise, and engagement strategies such as gamification. The primary outcome will be the change in age- and sex-standardized handgrip strength z-score from baseline to 12 weeks. Secondary outcomes will include glycemic stability, insulin requirements, cardiometabolic markers, physical literacy, quality of life, psychological well-being, app usability, and intervention engagement. Analyses will follow the intention-to-treat principle using mixed-effects models.
EXPECTED OUTCOMES AND DISCUSSION: This trial will assess whether a scalable mHealth-supported resistance-training program can improve muscular strength and support diabetes self-management in routine pediatric care. By testing Diactive-1 across multiple hospitals and real-world settings, the study will provide evidence on the external validity, feasibility, and potential clinical integration of digitally supported exercise education for youth with type 1 diabetes.
ETHICS AND DISSEMINATION: Ethical approval was granted by the Research Ethics Committee for Medicinal Products of the Government of Navarra. Written informed consent will be obtained from parents or legal guardians, with age-appropriate assent from minors. Findings will be disseminated through scientific conferences, peer-reviewed publications, and summaries shared with participating families.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT07290868, identifier NCT07290868.