Effectiveness of the Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1) on Insulin Requirements: Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Fundacion Miguel Servet
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Change in daily insulin dose requirement
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
This project involves a two-arm randomized controlled trial (RCT) designed to assess the feasibility, acceptability, and preliminary efficacy of a mobile application aimed at prescribing resistance training for children and adolescents with type 1 diabetes (Diactive-1). The program will span 24 weeks, with a minimum weekly frequency of 3 sessions. The researchers aim to recruit 52 participants but will enroll additional participants to account for potential withdrawals and ensure compliance with the desired sample size. The primary objective of the study is to evaluate the impact of the Diactive-1 mobile application on insulin requirements in children and adolescents with Type 1 Diabetes. Additionally, the researchers will investigate the effects of the Diactive-1 program on secondary parameters such as glycemic control, cardiometabolic indicators, physical fitness, and daily physical activity, among others. The hypothesis posits that personalized training through a mobile application, primarily focusing on muscular strength, will effectively reduce the daily insulin dosage in children and adolescents with type 1 diabetes.
Detailed Description
The primary objective of this study is to evaluate the effectiveness of the Diactive-1 mobile application, which offers personalized resistance training, in reducing daily insulin requirements among children and adolescents with type 1 diabetes. To achieve this objective, researchers will conduct a 24 weeks randomized controlled trial involving at least 52 participants diagnosed with type 1 diabetes. The study will consist of two groups: an experimental group utilizing the Diactive-1 application and a control group receiving standard treatment. Participant allocation to either group will be determined through central randomization. The Diactive-1 intervention encompasses several key features, including: (i) tailoring exercises based on initial physical fitness levels; (ii) adjusting the previous exercise to the glucose level measured through an interstitial glucose monitor or entered manually before the training session; (iii) monitoring heart rate during exercise; (iv) providing the flexibility to train with or without equipment, individually or with a partner; (v) dispensing diabetes management advice before and after each training session; and (vi) adapting training progressions based on session adherence. A face-to-face session will be conducted before commencing the intervention to ensure that participants are familiar with the fundamental movements, thus reducing the risk of potential muscle injuries.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 8-18 years old
- •At least 6 months post-diagnosis for type 1 diabetes
- •Ability to complete measures and intervention program in Spanish
- •Access to broadband or cellular internet
- •Patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.
Exclusion Criteria
- •Any comorbidity limiting the capacity to participate in physical activity or inadequate understanding of the Spanish language.
- •Participants will be excluded if they don't have access to the internet, lack a smartphone or tablet, or are unable to use the application.
Outcomes
Primary Outcomes
Change in daily insulin dose requirement
Time Frame: Baseline, 12 and 24 weeks
The daily insulin dose requirements will be measured in units per kilogram of body weight. Assessment will rely on participant-reported data from insulin pumps or injection logs, gathered for 9 days prior to the intervention, at 12 weeks, and after the intervention.
Secondary Outcomes
- Change in time in range(Baseline and 24 weeks)
- Change in sedentary behaviors(Baseline and 24 weeks)
- Change in cardio-ankle vascular index (CAVI)(Baseline and 24 weeks)
- Change in pulse wave velocity(Baseline and 24 weeks)
- Change in glycated hemoglobin(Baseline and 24 weeks)
- Number of participants with good glycemic control(Baseline and 24 weeks)
- Change in compliance with 24-hour movement behaviors(Baseline and 24 weeks)
- Change in self-reported physical activity(Baseline and 24 weeks)
- Change in isometric strength(Baseline, 12 and 24 weeks)
- Adherence to the Mediterranean Diet(Baseline and 24 weeks)
- Change in body mass index(Baseline, 12 and 24 weeks)
- Change in blood pressure(Baseline and 24 weeks)
- Change in heart rate variability(Baseline and 24 weeks)
- Change in disordered eating(Baseline and 24 weeks)
- Change in Health-Related Quality of Life in the context of a chronic illness(Baseline and 24 weeks)
- Change in lower limb muscle dynamic strength(Baseline and 24 weeks)
- Change in lower limb muscle power strength(Baseline and 24 weeks)
- Change in glycemic variability(Baseline and 24 weeks)
- Change in sleep quality(Baseline and 24 weeks)
- Change in Health-Related Quality of Life(Baseline and 24 weeks)
- Change in upper limb muscle power strength(Baseline and 24 weeks)
- Change in dietary behavior(Baseline and 24 weeks)
- Change in time below range(Baseline and 24 weeks)
- Change in time above range(Baseline and 24 weeks)
- Change in physical activity(Baseline, 12 and 24 weeks)
- Change in sleep duration(Baseline and 24 weeks)
- Change in cardiorespiratory fitness(Baseline and 24 weeks)
- Change in self-reported physical fitness(Baseline and 24 weeks)
- Change in visceral adiposity(Baseline, 12 and 24 weeks)
- Change in subjective well-being(Baseline and 24 weeks)
- Change in upper limb muscle dynamic strength(Baseline and 24 weeks)
- Change in lean mass(Baseline, 12 and 24 weeks)
- Change in bone mineral density(Baseline, 12 and 24 weeks)
- Change in blood lipids levels(Baseline and 24 weeks)
- Change in fat mass (percentage)(Baseline, 12 and 24 weeks)
- App usability(24 weeks)
- Change in fasting glucose(Baseline and 24 weeks)
- Change in fat mass (in kilograms)(Baseline, 12 and 24 weeks)
- Change in subcutaneos adiposity(Baseline, 12 and 24 weeks)
- Change in bone mineral content(Baseline, 12 and 24 weeks)
- Changes in liver enzymes(Baseline and 24 weeks)
- Change in inadvertent hypoglycemia(Baseline and 24 weeks)