Community-based Adolescent Diabetes Prevention Program
2019年11月20日 更新者：Icahn School of Medicine at Mount Sinai
TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth.
The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.
調査の概要
詳細な説明
Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY.
Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans.
Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk.
Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups.
Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.
研究の種類
介入
入学 (実際)
90
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。
研究場所
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New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
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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
13年～19年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria for pre-diabetes screening:
- Adolescents ages 13-19 years of age
- English speaking
Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:
- attending a school in East Harlem
- attending an after school or recreational activity in East Harlem
- receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
- At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
- No plans to relocate from New York City in the next year
Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test
Exclusion Criteria for pre-diabetes screening:
- <13 or >19 years of age
- Previous diagnosis of diabetes
- BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
- Currently pregnant
- Speaking a language other than English
- On medications that may raise or lower blood sugar
- Plans to relocate from New York City within one year of enrollment-
Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：TEEN HEED
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites.
The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
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Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
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介入なし：Wait List Control
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in body mass index (BMI)
時間枠：Baseline and 3 months
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Change in BMI at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in BMI
時間枠：Baseline and 1 year
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Change in BMI at 1 year as compared to baseline
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Baseline and 1 year
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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 |
|---|---|---|
|
Change in fasting blood glucose levels
時間枠：Baseline and 3 months
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Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in fasting blood glucose levels
時間枠：Baseline and 1 year
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Change in fasting blood glucose levels at 1 year as compared to baseline
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Baseline and 1 year
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Change in post prandial blood glucose level
時間枠：Baseline and 3 months
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Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in post prandial blood glucose level
時間枠：Baseline and 1 year
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Change in post prandial blood glucose level at 1 year as compared to baseline
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Baseline and 1 year
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Change in blood pressure
時間枠：Baseline and 3 months
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Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in blood pressure
時間枠：Baseline and 1 year
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Change in blood pressure at 1 year as compared to baseline
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Baseline and 1 year
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Change in percent body fat
時間枠：Baseline and 3 months
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Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in percent body fat
時間枠：Baseline and 1 year
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Change in percent body fat at 1 year as compared to baseline
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Baseline and 1 year
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Change in waist circumference
時間枠：Baseline and 3 months
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Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in waist circumference
時間枠：Baseline and 1 year
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Change in waist circumference at 1 year as compared to baseline
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Baseline and 1 year
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Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
時間枠：Baseline and 3 months
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Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
時間枠：Baseline and 1 year
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Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
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Baseline and 1 year
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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。
捜査官
- 主任研究者：Nita Vangeepuram, MD, MPH、Icahn School of Medicine at Mount Sinai
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)
2016年11月11日
一次修了 (実際)
2019年8月24日
研究の完了 (実際)
2019年8月24日
試験登録日
最初に提出
2015年5月22日
QC基準を満たした最初の提出物
2015年5月27日
最初の投稿 (見積もり)
2015年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月21日
QC基準を満たした最後の更新が送信されました
2019年11月20日
最終確認日
2019年11月1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。
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