Familial Overweight: Comparing Use of Strategies (FOCUS)
2015年5月19日 更新者：Brian Saelens、Seattle Children's Hospital
Behavioral Skill Adherence in Pediatric Obesity Treatment
The purpose of this study is to compare the efficacy of two different approaches (prescribed & self-directed) to the treatment of childhood obesity and their relative impact on child weight status, physical activity, and diet.
調査の概要
詳細な説明
Pediatric obesity is a highly prevalent problem, requiring both treatment and prevention efforts to reduce cardiovascular disease risk and metabolic consequences among affected children and the child population.
The efficacy of family-based behavioral pediatric obesity treatment is likely compromised by non-optimal parent and child behavioral skills use (BSU).
In pediatric obesity treatment trials, BSU assessment is infrequent, incomplete, and has unknown reliability.
Poor and incomplete BSU measurement precludes improving behavioral interventions for pediatric obesity.
Furthermore, different approaches to help families initiate and sustain BSU during and following treatment have not been tested.
This study aims to investigate 1) prospective relations between BSU measured during and following treatment and change in child weight status, physical activity, and diet, and 2) differences in BSU trajectory between two different implementation approaches during and following treatment.
Eighty-two parent-child (7-11 y.o.) pairs will participate in a 20-week treatment with follow-up at 3 and 6 months.
Participants will be randomly assigned to receive either a prescriptive or self-directed implementation approach to family-based behavioral pediatric obesity treatment.
BSU (monitoring, contingency management, environmental control) will be reported or assessed at pre-treatment, at the 5th, 10th, and 15th treatment sessions, at post-treatment and at the 3-month and 6-month follow-ups by the parent, interventionist, and supplemental evaluator.
Prospective associations between BSU, measured multiple times and by multiple informant/formats, and change in child weight status (z-BMI) and weight-related behaviors (diet, physical activity) over the course of treatment and throughout follow up will be examined.
This proposal will provide important information about the type of BSU and its measurement that is most related to short- and long-term treatment efficacy, and provide pilot data on the relative efficacy of different implementation approaches to initiate and sustain BSU in pediatric obesity intervention.
研究の種類
介入
入学 (実際)
72
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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Washington
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Seattle、Washington、アメリカ、98101
- Seattle Children's Hospital Research Institute
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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
7年～11年 (子)
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:
- Child age: 7-11 years.
- English-speaking.
- Parent is willing and able to actively participate in treatment.
- Overweight child: at or above 85th percentile for age- and gender-specific BMI, but not more than 175% above median BMI for age and gender.
- Overweight parent: BMI≥ 25.
- Live within 50 miles of Children's Hospital and Regional Medical Center.
Exclusion Criteria:
- Medical condition known to promote obesity (e.g. Prader-Willi syndrome, Cushing's syndrome).
- Already involved with another weight control program.
- Consistently engaging in weight-affecting behaviors (e.g. child: smoking)
- Significant diagnosed obesity-related co-morbidities (e.g. Type 2 diabetes)
- Taking weight-affecting medications (e.g. Ritalin)
- Participating parent or child: an existing thought disorder, suicidality, substance abuse disorder, or other psychological or medical conditions that may preclude full participation.
- Participating parent or child: Disability or illness that would preclude them from engaging in at least moderate intensity physical activity.
- Participating parent or child: Current or prior diagnosed eating disturbance.
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：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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アクティブコンパレータ：Prescribed Skills
Behavioral skills are all prescribed and considered necessary tools expected to be used consistently, completely, and uniformly by all participants throughout treatment
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Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
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実験的：Self-Directed Skills
Behavioral skills are considered a tool box from which families are encouraged to select skills that best apply to that family's situation in attempts to help their child make eating and activity change.
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Treatment will be delivered over a 20-week period.
Participating children and at least one of their parents will attend weekly in-person clinic sessions.
Treatment will consist of 20-25 minute meetings between the assigned interventionist and each child/parent pair to individualize treatment, with an emphasis on helping the family change eating and activity behaviors.
Family meetings will be followed by separate child and parent group meetings lasting approximately 35-45 minutes.
In both approaches, parents serve as primary implementers of the treatment for the child and, if overweight, for themselves.
Group sessions provide education in diet and physical activity, parenting, and behavioral skills, although conditions differ in whether skills are "prescribed" or "self-directed".
Children and parents will be weighed at each clinic visit.
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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 |
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Child weight status, physical activity, & diet.
時間枠：6 Months
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6 Months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Secondary outcomes will include parents' BMI, and parents' physical activity and eating behaviors and covariates will include child age, gender, and household income.
時間枠：6 Months
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6 Months
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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：Brian E Saelens, PhD、Seattle Children's Hospital Research Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2008年5月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2012年12月1日
試験登録日
最初に提出
2008年9月3日
QC基準を満たした最初の提出物
2008年9月3日
最初の投稿 (見積もり)
2008年9月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月21日
QC基準を満たした最後の更新が送信されました
2015年5月19日
最終確認日
2015年5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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