Finding the Patient's Voice Diabetes Prevention Programs
Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
調査の概要
詳細な説明
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:
- helping youth/families understand the importance of prevention,
- on-going interest and participation, and
- differing personal beliefs.
Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Indiana
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Carmel、Indiana、アメリカ、46032
- Riley Children's Specialties
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Indianapolis、Indiana、アメリカ、46202
- Indiana University School of Medicine
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Indianapolis、Indiana、アメリカ、46202
- Riley Children's Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
At least two of the following risk factors:
- Have been diagnosed with prediabetes;
- Have a family history of T2DM in first- and second-degree relatives;
- Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
- Have conditions associated with insulin resistance; and/or
- Have had gestational diabetes or were exposed to gestational diabetes in utero.
- A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).
Exclusion Criteria:
1. Type 2 diagnosis
研究計画
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：防止
- 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 |
|---|---|
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実験的：Intervention
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study.
It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
|
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study.
It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
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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 |
時間枠 |
|---|---|
|
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
時間枠：12 months
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hemoglobin A1C
時間枠：12 months
|
12 months
|
|
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Physical activity
時間枠：12 months
|
self-report
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12 months
|
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Quality of life
時間枠：12 months
|
Pediatric Quality of Life Inventory
|
12 months
|
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Intervention group session attendance
時間枠：12 months
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12 months
|
|
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Dietary records
時間枠：12 months
|
Semi-quantitative food frequency questionniare
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12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Tamara Hannon, MD、Indiana University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。