Healthy Families: Transforming Care for Obese Children at NYU Lutheran Family Health Centers
調査の概要
詳細な説明
The proposed intervention will engage pediatricians at NYU Lutheran Family Health Centers (NYU LFHC) and providers at the school-based clinics in referring Hispanic children ages 9-11 years with a BMI between the 95th and 99th percentile to the study. In addition, a list will be generated from NYU Lutheran's Quality Improvement department if recruitment through providers is low. Providers will refer patients who meet the above criteria through eClincialWorks (ECW). A research assistant will then randomize the referrals after acquiring informed consent forms to either the control group or the intervention group. The control group will receive standard of care by nutritionists at NYU LFHC. The intervention group will receive a 27-hour intervention session which will be split into a 12-session series. The sessions will be conducted weekly over a 3 month period. This study will include three cycles with three separate cohorts.
The Healthy Families Intervention Group will include:
- Bilingual English and Spanish group nutrition education, behavioral social support, and physical activity (e.g. kickboxing, Zumba, yoga, aerobics).
- Monthly home visits by a nutritionist for family including specific recommendations on food purchasing and preparation.
Children randomized to standard of care will attend monthly sessions with a nutritionist.
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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New York
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Brooklyn、New York、アメリカ、11220
- NYU Lutheran Medical Center
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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:
- Patient of NYU-LFHC Women's, Pediatric, and Adolescent Medicine (5610)
- Hispanic ethnicity
- BMI percentile between the 95th and 99th
- Ages between 9 and 11 years old at the time the program begins
Exclusion Criteria:
- Autism Spectrum Disorder (299.0)
- Pervasive Developmental Disorder-Not Otherwise Specified (PDD NOS 299.9) and
- Other PDD (299.8)
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:処理
- 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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介入なし:Nutrition Group
This group will go through standard of care and visit the nutritionist on a monthly basis for the three months that they are a part of the study.
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実験的:Healthy Families Group
Participants and their families will attend a weekly nutrition session, social support session and physical activity session for 12 weeks.
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The social worker for the parent support group addresses culturally specific questions and adopts culturally acceptable strategies for setting limits and promoting healthy behaviors, engaging the group as a whole and building peer support.
Nutrition sessions will focus on how to make traditional Latin American foods healthier, including the sharing of recipes and learning what foods to buy in local supermarkets.
Home visits by the nutritionist assists with family-centric strategies for healthier eating in their urban Latino households, including those with large extended families.
45 minutes physical activity session to promote healthy behaviors
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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 |
---|---|---|
Stabilize Body Mass Index (BMI)
時間枠:3 months
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The goal is to stabilize or reduce the participant's BMI at the end of the study.
The height and weight of the control group will be measured at baseline and at the end of 3 months.
The height and weight of the intervention group will be measured at over 12 sessions within the 3 month time frame.
The intervention will be 27 hours in total.
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3 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 |
---|---|---|
Differences in 5-2-1-0 measures between baseline and post-intervention session
時間枠:3 months
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Compare pre-intervention and post-intervention data within the control and intervention group for cases for the following behaviors: physical activity, consumption of fruit and vegetables, sugar-sweetened beverages, and daily screen time (watching TV/YouTube, playing video games, using tablet/phone/mobile device), which will be collected through the 5-2-1-0 validated survey.
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3 months
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Stabilize BMI z-score
時間枠:3 months
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The goal is to stabilize BMI z-score by the end of 3 months.
The BMI z-score will be calculated using the BMI collected in the primary outcome measure.
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3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Marisol Gonzalez, MD、NYU Lutheran
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
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