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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)

2026年6月19日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

280

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • スペイン
      • Seville、スペイン
        • 募集
        • Adhera Health (Virtual Participation)
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility of the ACDP-O Intervention
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Glycemic Control (T1D Cohorts)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Adhera Health, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月30日

一次修了 (実際)

2026年3月27日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年6月5日

QC基準を満たした最初の提出物

2026年6月5日

最初の投稿 (実際)

2026年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • DASH-Obesity

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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