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DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions (DASH-Obesity)

2026년 6월 19일 업데이트: Adhera Health, Inc.

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

280

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 스페인
      • Seville, 스페인
        • 모병
        • Adhera Health (Virtual Participation)
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Experimental: Adhera Caring Digital Program-Obesity (ACDP-O)
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.
행동: Adhera 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of the ACDP-O Intervention
기간: 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.
Baseline to Day 90
Acceptability of the ACDP-O Intervention
기간: 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.
Day 90
Change in Family Well-being
기간: 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.
Baseline and Day 90
Change in Quality of Life (Distress)
기간: 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.
Baseline and Day 90
Change in Mental Well-being (DASS-21)
기간: 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.
Baseline and Day 90
Change Quality of Life (KIDSCREEN-10)
기간: 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.
Baseline and Day 90

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Glycemic Control (T1D Cohorts)
기간: Baseline and Day 90
Change in self-reported HbA1c. Difference between baseline and post-intervention HbA1c values among participants with Type 1 Diabetes.
Baseline and Day 90
Participant Engagement
기간: Day 1 to Day 90
Frequency of application use and intervention adherence. Measured through platform usage logs and completion of assigned activities.
Day 1 to Day 90
Change in Hypoglycemia Awareness (T1D Cohorts)
기간: 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
Change in diabetes-related well-being (Diabetes cohort)
기간: 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.
Baseline and Day 90

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Adhera Health, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 10월 30일

기본 완료 (실제)

2026년 3월 27일

연구 완료 (추정된)

2026년 9월 1일

연구 등록 날짜

최초 제출

2026년 6월 5일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 19일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DASH-Obesity

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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