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.
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.
T1D and normal weight (BMI between the 10th and 85th percentile), or
T1D and overweight/obesity (BMI ≥85th percentile), or
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.
Single group
Adhera Caring Digital Program-Obesity (ACDP-O)
BehavioralThe 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
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.
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.
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.
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.
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.
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).
Participant Engagement
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)
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.
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