Intellectual Disabilities (F70-F79)IDHEAPPNCT07101523
Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities
A study testing mHealth in people with Intellectual Disabilities (F70-F79) and Down Syndrome (DS), run by University of Seville at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 30 years
- Conditions the study is for
- Intellectual Disabilities (F70-F79), Down Syndrome (DS), Autism Disorder
- What is being tested?
- mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of intellectual disability
- Being able to follow basic instructions
- Age between 4-30 years old
Who cannot join
- presence of severe sensory or motor impairments
- medical conditions that contraindicated moderate physical activity
- unable to access an smartphone during the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Facultad Ciencias de la Educación
Seville, Spain, 41013
Borja Sañudo, PhD, 0034652387090, bsancor@us.es
About this study
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]:
Read more
- 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.
Read the detailed description
Young individuals with intellectual disabilities (ID) often exhibit significant challenges in maintaining healthy lifestyle habits, particularly concerning physical activity and nutrition. Current evidence indicates that individuals with ID participate in significantly lower levels of physical activity compared to their typically developing peers, with a substantial proportion not meeting established physical activity guidelines. A recent literature review highlights that adults with ID often exhibit elevated levels of sedentary behaviour, which is associated with increased prevalence of obesity, multimorbidity, and metabolic syndrome. The review emphasizes that sedentary behaviour may contribute to the poor health commonly observed in this population. In addition to insufficient physical activity, dietary patterns among young people with intellectual disabilities often skew towards processed foods high in sugar and fat, further compounding their overall health risks.
Addressing these unhealthy behaviors is critical, as they significantly impact the overall well-being of young individuals with ID. Various strategies have been developed to manage and improve lifestyle-related health outcomes in this population. Interventions focusing on lifestyle modifications commonly emphasize structured exercise programs and nutritional education, aiming to promote sustainable, positive health behaviors. However, traditional intervention approaches often face significant challenges in effectively engaging young people with ID, limiting their long-term impact.
In recent years, mobile health (mHealth) interventions have emerged as innovative tools that leverage technology to enhance physical activity and nutritional habits among young individuals with ID. These digital solutions have demonstrated efficacy in promoting behaviour change through interactive, user-friendly platforms, offering an especially attractive alternative for populations that often encounter barriers in traditional health intervention contexts. Existing studies indicate that mHealth applications can facilitate behaviour modification by providing tailored feedback, goal-setting functionalities, and motivational elements, such as gamification.
Despite the significant promise of mHealth interventions in promoting healthier behaviors, evidence regarding their efficacy specifically among individuals with ID remains scarce. Most existing studies have focused on the general population, with limited research adapting these technologies to the cognitive, social, and communication needs of individuals with ID. Several barriers may limit the effectiveness and scalability of mHealth solutions in this population, including difficulties with digital literacy, limited accessibility features in current applications, lack of caregiver or support system involvement, and challenges related to sustained engagement over time. Consequently, there is a critical need for rigorously designed studies that not only evaluate the effectiveness of mHealth interventions for young individuals with ID, but also systematically address the unique barriers this population faces in accessing and benefiting from such technological innovations. Additionally, a significant gap persists in research that adequately considers the diverse manifestations of intellectual disability (e.g., such as Down syndrome and other neurodevelopmental conditions), leading to an incomplete understanding of the true potential and limitations of mHealth solutions across the full spectrum of cognitive and functional profiles. To date, there are only a limited number of studies specifically exploring the use of mHealth interventions to promote physical activity among individuals with ID. Various initiatives demonstrate the feasibility of integrating digital tools to promote physical activity among individuals with ID, they also present notable limitations. These include small sample sizes and a focus on specific subgroups, which hinder the generalizability of their findings. Furthermore, many of these studies predominantly involved adult participants, leaving a significant gap in research related to younger populations, where early intervention is crucial for fostering long-term healthy behaviors. In response to these gaps, our study aims to conduct a randomized controlled trial (RCT) to assess the effectiveness of mHealth interventions in improving physical activity and nutrition in young individuals with ID. By addressing the unique barriers this population faces in engaging with digital health solutions, our research seeks to provide a more comprehensive and inclusive understanding of how mHealth interventions can positively impact health outcomes during this critical developmental stage. Through this approach, we aim to identify effective strategies for promoting sustainable behavior change in young individuals with ID.
Methods Study Design 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.
- Being tested
- mHealth
- Keywords
- Intellectual Disabilities, Physical Activity, Sedentary Behavior, mHealth, Health Behavior Change, Health Promotion, Lifestyle Intervention
- Medical subject headings
- Intellectual Disability, Down Syndrome, Autistic Disorder, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthBehavioural
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:
- Increasing physical activity (e.g., "Walk an additional 1,000 steps today");
- Reducing sedentary behavior (e.g., "Stand up and move for at least 5 minut
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step count
was recorded as a proxy for general physical activity volume. This variable captured the total number of steps taken each day
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
light activity
Periods of low-intensity movement such as slow walking or light household tasks,
Measured: From enrollment to the end of treatment at 8 weeks
Sitting time
Total duration per day spent seated, used as a direct indicator of sedentary behavior
Measured: From enrollment to the end of treatment at 8 weeks
Total sleep time
Sum of all sleep periods in a given night
Measured: From enrollment to the end of treatment at 8 weeks
Children's Physical Activity Questionnaire (CPAQ)
To assess self-reported physical activity and sedentary behavior, the Children's Physical Activity Questionnaire (CPAQ) was administered to participants with the support of caregivers or facilitators when necessary. The CPAQ is a semi-structured, interviewer-administered instrument designed to evaluate the typical weekly frequency and duration of different activity types over the previous 7 days. Although originally developed for children, the CPAQ has been successfully adapted and validated in populations with intellectual and developmental disabilities due to its straightforward language and structure (McQueen et al., 2024).
Measured: From enrollment to the end of treatment at 8 weeks
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) A widely used instrument that assesses sleep quality over a one-month interval. It consists of 19 items grouped into 7 components: a) Subjective sleep quality, b) Sleep latency (time to fall asleep), c) Sleep duration, d) Habitual sleep efficiency, e) Sleep disturbances, f) Use of sleep medication, g) Daytime dysfunction. Each component is scored from 0 to 3, and the sum yields a global score (0-21), with higher scores indicating poorer sleep quality. A global score >5 is considered indicative of poor sleep.
Measured: From enrollment to the end of treatment at 8 weeks
health-related quality of life (HRQoL)
To assess health-related quality of life (HRQoL) in individuals with intellectual disabilities, the study employed the Quality of Life Inventory - Intellectual Disability (QI-Disability). This is a validated, condition-specific instrument designed to capture the multidimensional nature of quality of life in individuals with cognitive impairments, including those with mild to severe intellectual disability (Downs et al., 2019). The QI-Disability evaluates six core domains of HRQoL: a) Physical Health, b) Negative Emotions, c) Positive Emotions, d) Social Participation, e) Interpersonal Relationships and f) Independence. Each item is rated on a 4-point Likert scale ranging from "never" to "always," with higher scores indicating a more favorable quality of life in the respective domain. The QI-Disability has shown robust psychometric properties, including high internal consistency and construct validity, in populations with intellectual disabilities (Downs et al., 2019). Importantly, it
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Disabilities (F70-F79)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Principal investigator, Borja Sañudo, University of Seville
- Investigators
- Borja Sañudo, PhD, Principal investigator, University pof Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101523
- Sponsor's protocol ID
- IDHEAPP_101134252
- Acronym
- IDHEAPP
- Status last verified
- Jan 2025
- First submitted
- 28 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) that will be shared include de-identified data related to primary and secondary outcomes, such as measures of physical activity (e.g., step counts, activity duration), sleep duration, and nutrition-related behaviors. Only IPD used in the results publication will be shared. No personally identifiable information will be included. Data will be shared in accordance with applicable ethical approvals and data protection regulations. Due to the vulnerability of the study population, access to the IPD will be limited to qualified researchers upon reasonable request and subject to a data sharing agreement that ensures confidentiality and appropriate data use.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT07101523
- Acronym / sponsor ID
- IDHEAPP / IDHEAPP_101134252
- Keywords
- Intellectual Disabilities, Physical Activity, Sedentary Behavior, mHealth, Health Behavior Change, Health Promotion, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Young individuals with intellectual disabilities (ID) often exhibit significant challenges in maintaining healthy lifestyle habits, particularly concerning physical activity and nutrition. Current evidence indicates that individuals with ID participate in significantly lower levels of physical activity compared to their typically developing peers, with a substantial proportion not meeting established physical activity guidelines. A recent literature review highlights that adults with ID often exhibit elevated levels of sedentary behaviour, which is associated with increased prevalence of obesity, multimorbidity, and metabolic syndrome. The review emphasizes that sedentary behaviour may contribute to the poor health commonly observed in this population. In addition to insufficient physical activity, dietary patterns among young people with intellectual disabilities often skew towards processed foods high in sugar and fat, further compounding their overall health risks.
Addressing these unhealthy behaviors is critical, as they significantly impact the overall well-being of young individuals with ID. Various strategies have been developed to manage and improve lifestyle-related health outcomes in this population. Interventions focusing on lifestyle modifications commonly emphasize structured exercise programs and nutritional education, aiming to promote sustainable, positive health behaviors. However, traditional intervention approaches often face significant challenges in effectively engaging young people with ID, limiting their long-term impact.
In recent years, mobile health (mHealth) interventions have emerged as innovative tools that leverage technology to enhance physical activity and nutritional habits among young individuals with ID. These digital solutions have demonstrated efficacy in promoting behaviour change through interactive, user-friendly platforms, offering an especially attractive alternative for populations that often encounter barriers in traditional health intervention contexts. Existing studies indicate that mHealth applications can facilitate behaviour modification by providing tailored feedback, goal-setting functionalities, and motivational elements, such as gamification.
Despite the significant promise of mHealth interventions in promoting healthier behaviors, evidence regarding their efficacy specifically among individuals with ID remains scarce. Most existing studies have focused on the general population, with limited research adapting these technologies to the cognitive, social, and communication needs of individuals with ID. Several barriers may limit the effectiveness and scalability of mHealth solutions in this population, including difficulties with digital literacy, limited accessibility features in current applications, lack of caregiver or support system involvement, and challenges related to sustained engagement over time. Consequently, there is a critical need for rigorously designed studies that not only evaluate the effectiveness of mHealth interventions for young individuals with ID, but also systematically address the unique barriers this population faces in accessing and benefiting from such technological innovations. Additionally, a significant gap persists in research that adequately considers the diverse manifestations of intellectual disability (e.g., such as Down syndrome and other neurodevelopmental conditions), leading to an incomplete understanding of the true potential and limitations of mHealth solutions across the full spectrum of cognitive and functional profiles. To date, there are only a limited number of studies specifically exploring the use of mHealth interventions to promote physical activity among individuals with ID. Various initiatives demonstrate the feasibility of integrating digital tools to promote physical activity among individuals with ID, they also present notable limitations. These include small sample sizes and a focus on specific subgroups, which hinder the generalizability of their findings. Furthermore, many of these studies predominantly involved adult participants, leaving a significant gap in research related to younger populations, where early intervention is crucial for fostering long-term healthy behaviors. In response to these gaps, our study aims to conduct a randomized controlled trial (RCT) to assess the effectiveness of mHealth interventions in improving physical activity and nutrition in young individuals with ID. By addressing the unique barriers this population faces in engaging with digital health solutions, our research seeks to provide a more comprehensive and inclusive understanding of how mHealth interventions can positively impact health outcomes during this critical developmental stage. Through this approach, we aim to identify effective strategies for promoting sustainable behavior change in young individuals with ID.
Methods Study Design 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: mHealthThe 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 |
| 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. |
Who may qualify
- Ages
- 4 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of intellectual disability
- Being able to follow basic instructions
- Age between 4-30 years old
Key exclusion criteria (3 listed)
- presence of severe sensory or motor impairments
- medical conditions that contraindicated moderate physical activity
- unable to access an smartphone during the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthThe 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 | Behavioural | Lifestyle intervention |
Primary outcome
Daily step count
Time frame: From enrollment to the end of treatment at 8 weeks
was recorded as a proxy for general physical activity volume. This variable captured the total number of steps taken each day
6 secondary outcomes
light activity
Time frame: From enrollment to the end of treatment at 8 weeks
Sitting time
Time frame: From enrollment to the end of treatment at 8 weeks
Total sleep time
Time frame: From enrollment to the end of treatment at 8 weeks
Children's Physical Activity Questionnaire (CPAQ)
Time frame: From enrollment to the end of treatment at 8 weeks
Sleep quality
Time frame: From enrollment to the end of treatment at 8 weeks
health-related quality of life (HRQoL)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) that will be shared include de-identified data related to primary and secondary outcomes, such as measures of physical activity (e.g., step counts, activity duration), sleep duration, and nutrition-related behaviors. Only IPD used in the results publication will be shared. No personally identifiable information will be included. Data will be shared in accordance with applicable ethical approvals and data protection regulations. Due to the vulnerability of the study population, access to the IPD will be limited to qualified researchers upon reasonable request and subject to a data sharing agreement that ensures confidentiality and appropriate data use.
Related trials for Intellectual Disabilities (F70-F79)
RecruitingObservational study
Falls In Spanish People With Intellectual Disabilities: Risk Factors And Predictive Equation. Falls.Di Study
Falls, Intellectual Disabilities (F70-F79)
Recruiting
Smart Inhaler and Remote Asthma Management in Adolescents With Intellectual and Developmental Disabilities
Asthma in Children, Intellectual Disabilities (F70-F79)
Not yet recruiting
A Single-Arm Interventional Trial of Pepper- Robot Delivered Cancer Education for Adults With Intellectual Disability
Cancer Awareness and Prevention Education, Breast Cancer Awareness
Not yet recruiting
Emotion Processing and Regulation in People With Intellectual Disability
Intellectual Disabilities (F70-F79), Autism Spectrum Disorder
Recruiting
Optimizing Dimensions of Reinforcement
Intellectual Disabilities (F70-F79), Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Borja Sañudo, PhD principal investigator
University pof Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Intellectual Disabilities (F70-F79) and Down Syndrome (DS), run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Borja Sañudo, PhD (+34652387090, bsancor@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily step count (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.