Behavioral Rx & Nutrition in Pediatric Chronic Disease (LAUNCH)
LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health
The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is:
H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Ohio
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Cincinnati、Ohio、アメリカ、45229
- Cincinnati Children's Hospital 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:
- child age between 2- 5 years;
- child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
- medical clearance from pediatrician; and
- at least one parent with a BMI > 25. -
Exclusion Criteria:
- non-English speaking;
- living more than 50 miles from the medical center;
- a disability/illness that would preclude engagement in at least moderate physical activity;
- medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.
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：独身
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：Clinic and Home Behavioral Intervention
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A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions.
Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.
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アクティブコンパレータ：Pediatrician Counseling
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A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children
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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 |
|---|---|
|
BMI z score
時間枠：Baseline, 6 months, 12 months
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Baseline, 6 months, 12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Parent weight loss
時間枠：baseline, 24 weeks, 48 weeks
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baseline, 24 weeks, 48 weeks
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Child caloric intake
時間枠：baseline, 6 months, 12 months
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baseline, 6 months, 12 months
|
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Home food and activity environment
時間枠：baseline, 6 months, 12 months
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baseline, 6 months, 12 months
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Child physical activity
時間枠：baseline, 6 motnhs, 12 months
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baseline, 6 motnhs, 12 months
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Parent-child mealtime interactions
時間枠：baseline, 6 months, 12 months
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baseline, 6 months, 12 months
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協力者と研究者
協力者
捜査官
- 主任研究者：Lori J Stark, Ph.D.、Children's Hospital Medical Center, Cincinnati
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。