Asthma Acute, Asthma (Diagnosis), Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, T1D, Type 1 Diabetes
Conditions
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
Brief 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. 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.
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.
Interventions
BEHAVIORALAdhera Caring Digital Program-Obesity (ACDP-O)
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
Sponsors
Adhera Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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). * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the ACDP-O Intervention | Baseline to Day 90 | 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. |
| Acceptability of the ACDP-O Intervention | Day 90 | Participant and caregiver satisfaction with the intervention. Acceptability will be assessed using post-intervention satisfaction surveys based on a 5-point Likert scale. |
| Change in Mental Well-being (DASS-21) | Baseline and Day 90 | 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. |
| Change in Family Well-being | Baseline and Day 90 | 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. |
| Change in Quality of Life (Distress) | Baseline and Day 90 | 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. |
| Change Quality of Life (KIDSCREEN-10) | Baseline and Day 90 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control (T1D Cohorts) | Baseline and Day 90 | Change in self-reported HbA1c. Difference between baseline and post-intervention HbA1c values among participants with Type 1 Diabetes. |
| Change in Hypoglycemia Awareness (T1D Cohorts) | Baseline and Day 90 | 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). |
| Participant Engagement | Day 1 to Day 90 | Frequency of application use and intervention adherence. Measured through platform usage logs and completion of assigned activities. |
| Change in diabetes-related well-being (Diabetes cohort) | Baseline and Day 90 | 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. |
Countries
Spain
Contacts
CONTACTLuis Fernández Luque, PhD
Outcome results
None listed