ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Preventing the onset of pediatric obesity and diabetes in Latino families
The investigators will conduct a randomized controlled trial of a family-based community centered intervention. One-hundred Latino families with children ages 3-5 will be randomly allocated to either the intervention group (a 3-month skills building program to improve nutrition and aerobic activity for child-parent dyads) or a control group (literacy promotion). Through an active partnership with Nashville Metro Parks and Recreation and the Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will: 1) Implement an intervention for Latino families with young children that includes parent training, behavior modification training, nutrition education, and physical activity promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3) Evaluate how this intervention affects parenting practices for Latino families to improve nutrition and physical activity; and 4) Evaluate the ability to link families into a pediatric medical home if they have none identified. By developing innovative family-focused interventions, finding solutions to health conditions such as obesity and diabetes could be realized-con la familia.
調査の概要
詳細な説明
Obesity is a well-known risk factor for the development of diabetes. Obesity rates have rapidly increased over the past three decades for all Americans and have doubled for children. Latino children experience obesity at disproportionate rates. The most promising obesity interventions have focused on having children partner with a parent to set goals. Latino cultural norms emphasizing family provide a unique opportunity to develop family-centered interventions.
We will recruit 100 families (child-parent dyad) via a multi-pronged strategy including: provision of bilingual informational flyers; announcements on a Spanish radio program; and additional strategies developed by key community leaders in the Nolensville corridor. This recruitment approach has been successful for us in the past. Once recruited into the program, parent-child dyads will be randomly allocated to either the intervention group or control group (described below).
Intervention Group
Fifty (50) families will be randomly allocated to receive the Salud Con La Familia skills building curriculum at Coleman Community Center, which will include:
- Twelve (12) weekly 60-minute sessions in the recreation center (Refer to Table 1). The parent-child dyad will participate in 4 sessions from the En Sus Marcas curriculum, which was just tested by this study team (Barkin, PI). These sessions emphasize skills building around parenting, behavior modification, daily physical activity, and decreased sedentary activity. To this we will add 8 sessions from the Salud, Salsa, y Sabor25 curriculum, a best-practice program to improve nutrition and energy balance for Latino families, designed by the National Latino Children's Institute (NLCI) but not yet utilized in Tennessee. The combination of these two promising curricula results in a comprehensive program that includes all ADA-recommended elements of effective interventions for pediatric overweight.23 All sessions will be led by the same bilingual facilitators to ensure maximum fidelity and minimal difference between the information provided to participants. While this program has been designed in active partnership with Nashville Metro Parks and Recreation, we are also currently conducting a listening tour with key informants from the Nolensville community to provide further input into the content and implementation of the Salud Con La Familia approach. Throughout, emphasis is placed on healthy lifestyles, not on weight loss or obesity.
- At the end of each session, the study team will facilitate creating a parent-child contract to develop concrete weekly goals around nutrition and physical activity. Such contracts are integral to behavior modification.26
- The study team will assess if families have an identified pediatric medical home and use this for preventive health visits. If no medical home is identified, the team will assist with this health connection.
Control Group Fifty (50) families will be allocated to participate monthly with a literacy promotion skills-building curriculum. They will receive flyers when family events are offered at the community center. They will participate in data collection at the same time-points as the intervention families. Refer to Table 2 for our project timeline.
Outcomes will include: growth trajectories, parenting practices, activity patterns, and link to medical home.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37211
- Coleman Community Recreation 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:
- Latino parents with children ages 3-5
- parent agrees to participate in all sessions
- parent can be reached via telephone contact over next 3 months
Exclusion Criteria:
- non-Latino parents
- children outside target age range
- parent not agreeing to participate in all sessions
- parent cannot be reached via telephone contact over next 3 months
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:ランダム化
- 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:Lifestyle counseling
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3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion
他の名前:
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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 |
---|---|
Growth trajectories (using BMI, waist circumference), body composition
時間枠:3 months
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3 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Physical activity accelerometry change over time, parental self-efficacy, child feeding questionnaire (parental food habits), identification of medical home
時間枠:3 months
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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:Shari Barkin, MD, MSHS、Vanderbilt University School of Medicine
出版物と役立つリンク
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。
Lifestyle counselingの臨床試験
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Oxford Biomedical Technologies, Inc.募集
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Universiti Sultan Zainal Abidin募集