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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhera Caring Digital Program-Obesity (ACDP-O) | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 90 |
| Change in Hypoglycemia Awareness (T1D Cohorts) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Fernández Luque, PhD | Contact | +1 (831) 345-5357 | luis@adherahealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adhera Health (Virtual Participation) | Recruiting | Seville | Spain |
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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.
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| 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).
| Baseline and Day 90 |
| Participant Engagement | Frequency of application use and intervention adherence. Measured through platform usage logs and completion of assigned activities. | 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. | Baseline and Day 90 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009765 | Obesity |
| D050177 | Overweight |
| D001249 | Asthma |
| D004194 | Disease |
| D063766 | Pediatric Obesity |
| D000084802 | Caregiver Burden |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D010335 | Pathologic Processes |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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