The Feeding Dynamic Intervention: Self Regulation of Intake in Preschoolers (FeeDIn)
The Feeding Dynamic Intervention Study
調査の概要
詳細な説明
Childhood obesity is a significant public health problem. In the last three decade, there has been a marked increase in the prevalence of childhood obesity. Currently, 23% of preschoolers (2-5 years) in the United States are overweight or obese, a critical period to target in hopes of reversing this trend. The purpose of this study is to test the efficacy of a novel obesity intervention program for preschool-aged children. Emerging consensus indicates that excessive, intrusive, overt control in feeding or a chaotic non-structured feeding environment are risk factors for childhood obesity. The 2007 Expert Committee Recommendations on the Prevention, Assessment, and Treatment of Childhood Obesity specifically identified maternal feeding practices as important, categorically stating there is consistent evidence to support "avoiding overly restrictive feeding behaviors." The guidelines emerged from a growing body of literature indicating that overly controlling caregiver feeding behaviors, in particular, significantly increase children's obesity risk.
Despite the evidence for the importance of feeding dynamics, no childhood obesity interventions focused on this area have been rigorously tested. The Feeding Dynamic Intervention (FDI) is a 12-week educational intervention. The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. We will recruit 84 mothers with 3- to 5-year-old obese children, randomly assigned to either the FDI or a comparison to a waiting list control group (WLG). At the end of the 6 month study we will assess knowledge and behavioral changes between the groups on (i) maternal self-reported feeding practices; (ii) improving energy compensation (COMPX), decreasing Eating in the Absence of Hunger (EAH) and increasing mother-reported satiety responsiveness in their child. Finally, we will investigate an exploratory hypothesis that children in the FDI group, compared to children in the wait-list control group, will demonstrate a lower increase in body mass index (BMI) z-score over 6 months.
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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Ohio
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Columbus、Ohio、アメリカ、43205
- Nationwide 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:
- The child is between ages 3-5 years (36 to 71 months). [Note if a family has more than one qualifying child we will choose the child with the lower CEBQ SR score and if they are equal we will randomly select the target child for the study dyad.]
- Child's body mass index > 85th percentile for age and sex
- This will be calculated based on age, weight and height using the Center for Healthy Weight and Nutrition BMI calculator [if mother is unsure of the weight and height ask whether she has been told her child is overweight or obese by the PCP]
- Child has significantly abnormal parent-reported impairment of energy regulation (Rating of 2.8 or lower on the CEB-Q).
- The mother is fluent in English (measures are limited to English at this time)
- Mother (or female caregiver) has primary legal and physical custody of the child and is primarily responsible for feeding the child. Specifically the child is not in a non-parental home daycare more than 20 hours/week. Structured child care centers are not included in this limitation because they use structure care and feeding techniques similar to those taught in the FeeDIn Program.
Exclusion Criteria:
- Child has a medical condition or takes a medication that affects appetite, eating, or growth;
- Child has food allergies or dietary restrictions that interfere with feeding or the study tests (i.e., milk, gluten and eggs?)
- Child has any developmental or behavioral diagnosis that might affect his/her ability to respond to a behaviorally-based intervention, e.g., cognitive impairment, language delay, or autism.
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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介入なし：No intervention- control group
Visits to physicians, WIC offices, nutrition program etc will be tracked.
The subjects will undergo the energy regulation tests at baseline and 3 months.
They will complete surveys and have their weight taken.
The control group subjects will have the opportunity to receive the intervention at the end of the study
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実験的：lifestyle counseling, parental feeding
Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI).
The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each.
Visits to physicians, WIC offices, nutrition program etc will be tracked.
The subjects will undergo the energy regulation tests at baseline and 3 months.
They will complete surveys and have their weight taken.
|
Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI).
The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each.
Visits to physicians, WIC offices, nutrition program etc will be tracked.
The subjects will undergo the energy regulation tests at baseline and 3 months.
They will complete surveys and have their weight taken.
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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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Increased Energy Regulation
時間枠：Change from baseline in energy compensation at 3 months and Change from baseline in energy compensation at 6 months
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Children in the FDI group, compared to children in the wait-list control group will show improved energy compensation regulation (COMPX), decreased Eating in the Absence of Hunger (EAH), and increasing Satiety Responsiveness (CEBQ-SR).
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Change from baseline in energy compensation at 3 months and Change from baseline in energy compensation at 6 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 |
|---|---|---|
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Reduce BMI
時間枠：Change from baseline in BMI-z score at 3 months and Change from baseline in BMI-z score at 6 months
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Children in the FDI group, compared to children in the wait-list control group, will demonstrate a lower increase in body mass index (BMI) z-score over 6 months.
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Change from baseline in BMI-z score at 3 months and Change from baseline in BMI-z score at 6 months
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協力者と研究者
捜査官
- 主任研究者：Ihuoma Eneli, MD, MS、Nationwide Children's Hospital
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 (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
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