Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities

NCT07101523 | Recruiting

• 1 other identifier: IDHEAPP_101134252
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

IDHEApp will implement various educational technology tools and work with the families, teachers and caregivers to increase physical activity (PA) and improve healthy eating. Due to the current COVID-19 pandemic restrictions, the use of innovative digital technology can contribute not just to distance learning but also to support families and students in remote. However, both healthy habits and technologies are insufficiently addressed in the population with IDD. These needs are in line with the following objectives of the Erasmus+ programme: a) Inclusion and diversity in all fields of education, training, youth and sport; b) Addressing digital transformation through development of digital readiness, resilience and capacity, and c) Encouraging the participation in sport and physical activity. Educators will find innovative possibilities and the right instruments that will enable them to fulfil their potential through innovative online education \& learning \& training skills module for lifestyle promotion and others available on the app. Furthermore, mentors and others health professionals (e.g., nursing etc.) will be equipped with knowledge and skills on how to use the app to teach practical skills for PA enhancement in an evidence-based way. Consequently, this project will contribute to \[specific objectives - SO\]: \- Raise awareness of the importance of healthy and active living among young Europeans with intellectual disabilities. Different workshops and bigger events (i.e., international conference), together with the involvement of numerous participants from the institutions of this consortium will be ensured. Further, a sensitized community will participate through the social networks and the website itself, in the proposed activities. \- Provide digital resources and tools to the partner entities of the exchange to improve lifestyle of young people with intellectual disabilities. Best Practices to provide high quality, inclusive digital health education with the best educational technology tools and methodology. A website, a mobile app and different electronic guidelines will be delivered. \- Analyze the current state of use and acceptance of technologies as support in the management of health in adolescent with intellectual disabilities.

Conditions

Intellectual Disabilities (F70-F79); Down Syndrome (DS); Autism Disorder

Keywords

Intellectual Disabilities; Physical Activity; Sedentary Behavior; mHealth; Health Behavior Change; Health Promotion; Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• Daily step count

  was recorded as a proxy for general physical activity volume. This variable captured the total number of steps taken each day

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

• light activity

  From enrollment to the end of treatment at 8 weeks

• Sitting time

  From enrollment to the end of treatment at 8 weeks

• Total sleep time

  From enrollment to the end of treatment at 8 weeks

• Children's Physical Activity Questionnaire (CPAQ)

  From enrollment to the end of treatment at 8 weeks

• Sleep quality

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

The intervention was carried out over a period of 8 consecutive weeks and was delivered through a mobile application specifically developed for this project, called IDHEApp, which incorporated gamification elements to enhance user engagement and motivation. Participants in the experimental group received a structured mHealth-based program aimed at promoting healthier behaviors in three primary domains: physical activity, sedentary behavior reduction, and dietary improvement. Objective data on physical activity and sedentary behavior were collected using a smartwatch device (Fitbit Versa 3), which was worn by all participants in both the experimental and control groups throughout the study. However, only participants in the experimental group received a daily personalized behavioral challenge targeting one of the following domains: 1. Increasing physical activity (e.g., "Walk an additional 1,000 steps today"); 2. Reducing sedentary behavior (e.g., "Stand up and move for at least 5 minu

Behavioral: mHealth

Control

NO INTERVENTION

The control group, in contrast, received no intervention and continued with their usual routines without additional support or monitoring beyond the baseline and post-intervention assessments.

Interventions

mHealth BEHAVIORAL

The intervention was carried out over a period of 8 consecutive weeks and was delivered through a mobile application specifically developed for this project, called IDHEApp, which incorporated gamification elements to enhance user engagement and motivation. Participants in the experimental group received a structured mHealth-based program aimed at promoting healthier behaviors in three primary domains: physical activity, sedentary behavior reduction, and dietary improvement. Objective data on physical activity and sedentary behavior were collected using a smartwatch device (Fitbit Versa 3), which was worn by all participants in both the experimental and control groups throughout the study. However, only participants in the experimental group received a daily personalized behavioral challenge targeting one of the following domains: 1. Increasing physical activity (e.g., "Walk an additional 1,000 steps today"); 2. Reducing sedentary behavior (e.g., "Stand up and move for at least 5 minut

Lifestyle intervention

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of intellectual disability
• Being able to follow basic instructions
• Age between 4-30 years old

You may not qualify if:

• presence of severe sensory or motor impairments
• medical conditions that contraindicated moderate physical activity
• unable to access an smartphone during the intervention

Sponsors & Collaborators

• University of Seville: lead
• University of Technology Munich: collaborator

Study Sites (1)

Facultad Ciencias de la Educación

Seville, Spain, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Intellectual Disability; Down Syndrome; Autistic Disorder; Motor Activity; Sedentary Behavior

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Borja Sañudo, PhD

  University pof Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Borja Sañudo, PhD

CONTACT

+34652387090; bsancor@us.es

Borja Sañudo, PhD

CONTACT

0034652387090; bsancor@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the behavioral mHealth intervention, participants and intervention facilitators could not be blinded to group allocation. However, outcome assessors and data analysts were masked to group assignments to minimize potential bias in data collection and analysis. Additionally, caregivers and teachers involved in routine support were not informed of specific hypotheses or group distinctions to reduce influence on participant behavior.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study followed a multicenter, randomized controlled trial (RCT) design and was conducted in two European cities: Rome (Italy) and Rijeka (Croatia). Participants were stratified by site and randomly assigned to either an experimental group, which received a gamified mHealth-based intervention aimed at improving physical activity and eating habits, or to a control group, which continued with their usual routines without intervention. In Rome, the sample included only individuals with Down syndrome, while in Rijeka the participants had mild to moderate intellectual disabilities without comorbid Down syndrome. Randomization was carried out using a computer-generated sequence, and the allocation was concealed until the moment of assignment. All procedures complied with the ethical standards of the institutional research committees and adhered to the Helsinki Declaration. Informed consent was obtained from participants or their legal representatives.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data (IPD) will be made available beginning 6 months after publication of the primary results and will remain available for a period of 5 years following publication.
• Access Criteria: Access to the de-identified individual participant data (IPD) will be granted to qualified researchers affiliated with academic or non-profit institutions for the purpose of secondary analyses related to intellectual disabilities, mHealth interventions, or health promotion. Requests must include a detailed research proposal, ethical approval or exemption, and a signed data use agreement. All requests will be reviewed by the study steering committee to ensure appropriate use and compliance with data protection regulations.

Locations

ES (1)