Type 1 DiabetesDASH-ObesityNCT07638345
DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions
A study testing Adhera Caring Digital Program-Obesity (ACDP-O) in people with Type 1 Diabetes and T1D, run by Adhera Health, Inc. at 1 site in Spain.
Trial summary
This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with overweight/obesity and chronic conditions, including type 1 diabetes (T1D) and asthma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, T1D, Obesity & Overweight
- What is being tested?
- Adhera Caring Digital Program-Obesity (ACDP-O)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2025to Sep 2026
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult caregiver (aged 18 years or older) of an adolescent or young adult aged 12 to 21 years diagnosed with Type 1 Diabetes (T1D) or asthma.
- The caregiver is actively involved in the management of the adolescent's or young adult's condition.
- The adolescent or young adult must meet one of the following criteria:
- T1D and normal weight (BMI between the 10th and 85th percentile), or
- T1D and overweight/obesity (BMI ≥85th percentile), or
- Asthma and overweight/obesity (BMI ≥85th percentile).
Show all 10Show fewer
- Willingness to participate in the Adhera Caring Digital Program-Obesity (ACDP-O).
- Access to a smartphone or internet-enabled device compatible with the study application.
- Willingness to provide self-reported information regarding the adolescent's or young adult's health status, including disease-related and anthropometric measures.
- For caregivers of participants with T1D, willingness to share continuous glucose monitoring (CGM) information.
Who cannot join
- Severe psychiatric or cognitive conditions that would interfere with participation in the digital intervention.
- Current participation in another obesity- or chronic disease-related digital health intervention study.
- Inability or unwillingness to comply with study procedures.
- Refusal or inability to provide informed consent.
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
Adhera Health (Virtual Participation)
Seville
Sara Belón, +1 (831) 345-5357, studies@adherahealth.com
About this study
Official title: US-based Clinical Sub-study of DASH-Obesity: Explainable AI for Family-Centric Transdiagnostic Personalized Weight Control Across Multiple Conditions
This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with overweight/obesity and chronic conditions, including type 1 diabetes (T1D) and asthma. The intervention combines personalized educational content, wearable-device monitoring, psychometric assessments, and explainable artificial intelligence (AI) to improve mental well-being, quality of life, and adherence to healthy lifestyle behaviors. A total of 280 families will participate in a 3-month intervention with remote monitoring and follow-up assessments.
Read the detailed description
The DASH-Obesity clinical sub-study investigates the feasibility, acceptability, and preliminary effectiveness of the Adhera Caring Digital Program for Obesity (ACDP-O) among families of adolescents and young adults affected by overweight/obesity and chronic conditions.
The intervention utilizes a mobile digital health platform that integrates educational content, behavioral support, psychometric monitoring, wearable-generated digital biomarkers, and explainable AI-based analytics. Participants include adolescents and young adults with overweight/obesity and type 1 diabetes, overweight/obesity and asthma, and a comparison cohort of participants with type 1 diabetes and normal weight.
The study follows a prospective, single-arm, pre-post basket trial design. Participants will complete baseline assessments, engage with the intervention for 90 days, and complete post-intervention and follow-up assessments. Outcomes include feasibility, acceptability, mental well-being, quality of life, caregiver burden, usability, engagement, and disease-specific clinical measures.
- Conditions
- Type 1 Diabetes, T1D, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Asthma Acute, Asthma (Diagnosis)
- Being tested
- Adhera Caring Digital Program-Obesity (ACDP-O)
- Keywords
- Pediatric Obesity, Type 1 Diabetes, Asthma, Overweight, Digital Health, Artificial Intelligence, Explainable AI, Caregiver Burden, Quality of Life, Mental Well-being, Wearable Devices, Family-Centered Care
- Medical subject headings
- Diabetes Mellitus, Type 1, Obesity, Overweight, Asthma, Disease, Pediatric Obesity, Caregiver Burden, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhera Caring Digital Program-Obesity (ACDP-O)Behavioural
The Adhera Caring Digital Program-Obesity (ACDP-O) is a mobile-based digital health intervention that provides personalized educational content, cognitive behavioral approach-based support, psychometric monitoring, wearable-device integration, remote monitoring, and explainable artificial intelligence tools. The intervention is designed to support weight management, healthy lifestyle behaviors, mental well-being, quality of life, and family engagement in adolescents and young adults with obesity and chronic conditions
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Adhera Caring Digital Program-Obesity (ACDP-O) | Experimental | Participants receive the Adhera Caring Digital Program-Obesity (ACDP-O), a family-centered digital health intervention delivered through a mobile application for 3 months. The intervention includes personalized educational content, psychometric assessments, wearable-device integration, remote monitoring, behavioral support, and explainable AI-driven feedback to support weight management, mental well-being, and quality of life among adolescents and young adults with type 1 diabetes or asthma and their caregivers. Receives: Behavioral: Adhera Caring Digital Program-Obesity (ACDP-O) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the ACDP-O Intervention
Participant completion rate of the 3-month digital intervention. Feasibility will be assessed as the proportion of enrolled participants who complete the intervention and final study assessments.
Measured: Baseline to Day 90
Acceptability of the ACDP-O Intervention
Participant and caregiver satisfaction with the intervention. Acceptability will be assessed using post-intervention satisfaction surveys based on a 5-point Likert scale.
Measured: Day 90
Change in Mental Well-being (DASS-21)
Change in Depression Anxiety Stress Scales (DASS-21) scores. The DASS-21 is a 21-item self-report questionnaire assessing symptoms of depression, anxiety, and stress. Total scores range from 0 to 63, with higher scores indicating greater psychological distress. The outcome is the change from baseline to Day 90.
Measured: Baseline and Day 90
Change in Family Well-being
Change in Computer Adaptive Testing (CAT)-based family well-being scores. Family well-being assessed through adaptive psychometric assessments derived from validated mental health questionnaires.
Measured: Baseline and Day 90
Change in Quality of Life (Distress)
Change in Distress Thermometer Score The Distress Thermometer is a single-item measure of psychological distress scored from 0 (no distress) to 10 (extreme distress). Higher scores indicate greater distress. The outcome is the change from baseline to Day 90.
Measured: Baseline and Day 90
Change Quality of Life (KIDSCREEN-10)
The KIDSCREEN-10 Index is a validated measure of health-related quality of life in children and adolescents. Raw scores are converted to a standardized T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate better health-related quality of life and a better outcome. The outcome measure is the change in KIDSCREEN-10 Index score from baseline to Day 90.
Measured: Baseline and Day 90
Secondary outcomes (4)
Change in Glycemic Control (T1D Cohorts)
Change in self-reported HbA1c. Difference between baseline and post-intervention HbA1c values among participants with Type 1 Diabetes.
Measured: Baseline and Day 90
Change in Hypoglycemia Awareness (T1D Cohorts)
Change in Clarke Hypoglycemia Awareness Scale score. The Clarke Hypoglycemia Awareness Scale is an 8-item questionnaire used to assess impaired awareness of hypoglycemia in individuals with diabetes. Total scores range from 0 to 7, with higher scores indicating worse hypoglycemia awareness (greater impairment in recognizing hypoglycemic episodes).
Measured: Baseline and Day 90
Participant Engagement
Frequency of application use and intervention adherence. Measured through platform usage logs and completion of assigned activities.
Measured: Day 1 to Day 90
Change in diabetes-related well-being (Diabetes cohort)
The INSPIRE Questionnaire for Parents of Youth with Type 1 Diabetes assesses parent perceptions of positive psychological and behavioral outcomes associated with diabetes management technologies and care. Scores are transformed to a 0 to 100 scale, with higher scores indicating more positive perceptions and experiences and a better outcome. The outcome measure is the change in total score from baseline to Day 90.
Measured: Baseline and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start30 Oct 2025
- Primary completion27 Mar 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group assignment study in which all participants receive the ACDP-O digital intervention. Outcomes are evaluated using a pre-post design over a 3-month intervention period, with comparisons conducted across predefined disease and weight-status cohorts.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adhera Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638345
- Sponsor's protocol ID
- DASH-Obesity
- Acronym
- DASH-Obesity
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No