Clinical trial NCT06048757: Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: mHealth
Resistance exercise
Insulin sensitivity
Glycemic control
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
name: Universidad Pública de Navarra
First posted: 2023-09-21
Enrollment: 62
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in daily insulin dose requirement
timeFrame: Baseline, 12 and 24 weeks
Secondary outcomes:
measure: Change in glycated hemoglobin
timeFrame: Baseline and 24 weeks
measure: Number of participants with good glycemic control
timeFrame: Baseline and 24 weeks
measure: Change in time in range
timeFrame: Baseline and 24 weeks
measure: Change in time below range
timeFrame: Baseline and 24 weeks
measure: Change in time above range
timeFrame: Baseline and 24 weeks
measure: Change in glycemic variability
timeFrame: Baseline and 24 weeks
measure: Change in compliance with 24-hour movement behaviors
timeFrame: Baseline and 24 weeks
measure: Change in physical activity
timeFrame: Baseline, 12 and 24 weeks
measure: Change in self-reported physical activity
timeFrame: Baseline and 24 weeks
measure: Change in sedentary behaviors
timeFrame: Baseline and 24 weeks
measure: Change in sleep duration
timeFrame: Baseline and 24 weeks
measure: Change in sleep quality
timeFrame: Baseline and 24 weeks
measure: Change in blood pressure
timeFrame: Baseline and 24 weeks
measure: Change in cardio-ankle vascular index (CAVI)
timeFrame: Baseline and 24 weeks
measure: Change in pulse wave velocity
timeFrame: Baseline and 24 weeks
measure: Change in heart rate variability
timeFrame: Baseline and 24 weeks
measure: Change in disordered eating
timeFrame: Baseline and 24 weeks
measure: Change in Health-Related Quality of Life in the context of a chronic illness
timeFrame: Baseline and 24 weeks
measure: Change in Health-Related Quality of Life
timeFrame: Baseline and 24 weeks
measure: Change in subjective well-being
timeFrame: Baseline and 24 weeks
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and 24 weeks
measure: Change in isometric strength
timeFrame: Baseline, 12 and 24 weeks
measure: Change in lower limb muscle dynamic strength
timeFrame: Baseline and 24 weeks
measure: Change in upper limb muscle dynamic strength
timeFrame: Baseline and 24 weeks
measure: Change in lower limb muscle power strength
timeFrame: Baseline and 24 weeks
measure: Change in upper limb muscle power strength
timeFrame: Baseline and 24 weeks
measure: Change in self-reported physical fitness
timeFrame: Baseline and 24 weeks
measure: Adherence to the Mediterranean Diet
timeFrame: Baseline and 24 weeks
measure: Change in dietary behavior
timeFrame: Baseline and 24 weeks
measure: Change in body mass index
timeFrame: Baseline, 12 and 24 weeks
measure: Change in fat mass (percentage)
timeFrame: Baseline, 12 and 24 weeks
measure: Change in fat mass (in kilograms)
timeFrame: Baseline, 12 and 24 weeks
measure: Change in lean mass
timeFrame: Baseline, 12 and 24 weeks
measure: Change in subcutaneos adiposity
timeFrame: Baseline, 12 and 24 weeks
measure: Change in visceral adiposity
timeFrame: Baseline, 12 and 24 weeks
measure: Change in bone mineral content
timeFrame: Baseline, 12 and 24 weeks
measure: Change in bone mineral density
timeFrame: Baseline, 12 and 24 weeks
measure: Change in blood lipids levels
timeFrame: Baseline and 24 weeks
measure: Change in fasting glucose
timeFrame: Baseline and 24 weeks
measure: Changes in liver enzymes
timeFrame: Baseline and 24 weeks
measure: Change in inadvertent hypoglycemia
timeFrame: Baseline and 24 weeks
measure: App usability
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Fundación Miguel Servet/ Navarrabiomed
state: Navarra
city: Pamplona
country: Spain
facility: Paediatric Endocrinology Unit at Hospital Universitario de Navarra
state: Navarra
Study officials:
affiliation: Fundación Miguel Servet - Navarrabiomed
name: Antonio García-Hermoso, PhD
role: PRINCIPAL_INVESTIGATOR
References: