Childhood Obesity Treatment: A Maintenance Approach (COMPASS)
2017年2月20日 更新者：Washington University School of Medicine
The purpose of this study is to determine the effect of dose and content of an enhanced weight maintenance treatment on children's ability to maintain weight loss following a standard weight loss treatment.
調査の概要
詳細な説明
Childhood Obesity (CO) prevalence in the United States has tripled in recent decades, and nearly 30% of children aged 6 to 11 are overweight or obese.
CO is a serious public health problem, and is associated with both immediate and long-term health problems (e.g., hypertension, type 2 diabetes, asthma) and psychosocial problems (e.g., social isolation, depression, eating disorder symptomatology).
Furthermore, CO is a significant risk factor for adult obesity with several prospective studies showing that, if untreated, about half of overweight grade-school children remain obese as adults.
Fortunately, children respond favorably to family-based behavioral weight loss treatment (FBT), the most well-established intervention for the treatment of overweight in children 7 to 12 years old.
Weight loss treatments for overweight children have been associated with significant physical and psychosocial health benefits; however, despite initial success with lifestyle interventions, considerable relapse often occurs once treatment ends.
Clearly, CO is a significant public health problem, and long-term maintenance of weight loss remains a priority to stem the increased costs to the individual and society.
Therefore, we propose to conduct a multi-site randomized controlled trial with overweight children (N=241) and their parents (N=241) [for a total N=482].
All participants will complete 4 months of FBT and then be randomized to one of three, 8-month maintenance conditions: (1) Weight Maintenance Therapy, who will receive SFM - Low Dose [LOW] (16 sessions over 8 months), (2) Intensive Weight Maintenance Therapy, who will receive SFM - High Dose [HIGH] (32 sessions over 8 months), or (3) Current Standard of Care, who will receive Weight Maintenance Education (16 sessions over 8 months).
Relative weight and associated outcomes will be assessed at 0 (pre-weight loss), 4 (post-weight loss), 12 (post-maintenance treatment),18 months and 24 months.
Additionally, brief assessments will be conducted at four points during the course of maintenance treatment to measure presumed mediators.
研究の種類
介入
入学 (実際)
482
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
-
-
Missouri
-
St. Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
-
Washington
-
Seattle、Washington、アメリカ、98121
- Seattle Children's Hospital Research Institute
-
-
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:
- Children will be between the ages of 7 and 11 and at or above the 85th percentile for weight.
- At least one parent of the participating child must be overweight (BMI ≥ 25).
- One parent must agree to attend all parent/child treatment meetings as the participating parent.
- Participants must be able to speak and comprehend English.
Exclusion Criteria:
- Participating parent or child having a thought disorder, suicidality, bipolar disorder, or drug or alcohol dependence.
- Participating parent or child having a physical disability or illness that prevents performance of physical activity at level equivalent to a brisk walk or that places severe restriction on diet.
- Participating parent or child being on a medication regimen that affects weight.
- Participating parent or child being involved in active psychiatric treatment for an ongoing problem that causes either social or occupational impairment.
- Parents (participating and nonparticipating) and children having an eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) or having subclinical levels of eating disturbance (i.e., reporting key eating disorder behaviors of purging, fasting, or binge eating more than two times per month).
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：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 |
|---|---|
|
アクティブコンパレータ：Weight Maintenance Education
Participants assigned to this group will receive the Weight Maintenance Education intervention.
They will meet every other week during the maintenance phase of the study for a total of 16 sessions over 8 months.
During the visit, participants will participate in a series of interactive workshops within child and parent groups to learn general information about healthy eating and physical activity.
|
The Weight Maintenance Education intervention will help participants in parent and child groups to learn more about healthy eating and physical activity in a group setting.
Participants will also learn about exercise and exercise safety, hydration during exercise, and stress management.
Parent and child groups will combine for particular on-site and off-site activities, such as cooking demonstrations, grocery store tours, gym tours, and dance lessons.
|
|
実験的：SFM+ Low Dose
Participants assigned to this group will receive the SFM+ Low Dose.
|
The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance.
Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers).
Participants in this group will meet less often than families that receive the Social Facilitation Maintenance (SFM) - High Dose intervention, giving them more opportunities to practice new skills between clinic visits.
|
|
実験的：SFM+ High Dose
Participants assigned to this group will receive the SFM+ High Dose.
|
The SFM intervention assumes people need a social environment that supports changes in eating and physical activity for continued weight maintenance.
Therefore, the SFM intervention will focus on helping families create a social environment that supports weight maintenance (e.g., children being friends with physically active peers).
Participants in this group will meet more often than families that receive the Social Facilitation Maintenance (SFM) - Low Dose intervention, allowing for more in-depth discussion and practice of key skills and concepts related to creating a social environment that supports a healthy lifestyle.
These participants will receive more feedback and reinforcement from fellow group members, family interventionists, and group leaders for practicing their new behaviors.
|
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 |
|---|---|
|
子供の太りすぎ率
時間枠：1年
|
1年
|
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。
協力者
捜査官
- 主任研究者：Brian Saelens, Ph.D.、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。
一般刊行物
- Hayes JF, Altman M, Kolko RP, Balantekin KN, Holland JC, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Decreasing food fussiness in children with obesity leads to greater weight loss in family-based treatment. Obesity (Silver Spring). 2016 Oct;24(10):2158-63. doi: 10.1002/oby.21622. Epub 2016 Sep 7.
- Altman M, Cahill Holland J, Lundeen D, Kolko RP, Stein RI, Saelens BE, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Reduction in food away from home is associated with improved child relative weight and body composition outcomes and this relation is mediated by changes in diet quality. J Acad Nutr Diet. 2015 Sep;115(9):1400-7. doi: 10.1016/j.jand.2015.03.009. Epub 2015 May 8.
- Holland JC, Kolko RP, Stein RI, Welch RR, Perri MG, Schechtman KB, Saelens BE, Epstein LH, Wilfley DE. Modifications in parent feeding practices and child diet during family-based behavioral treatment improve child zBMI. Obesity (Silver Spring). 2014 May;22(5):E119-26. doi: 10.1002/oby.20708. Epub 2014 Mar 25.
- Best JR, Theim KR, Gredysa DM, Stein RI, Welch RR, Saelens BE, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Behavioral economic predictors of overweight children's weight loss. J Consult Clin Psychol. 2012 Dec;80(6):1086-1096. doi: 10.1037/a0029827. Epub 2012 Aug 27.
- Fowler LA, Litt MD, Rotman SA, Conlon RPK, Jakubiak J, Stein RI, Balantekin KN, Welch RR, Perri MG, Epstein LH, Wilfley DE. Relation of social network support to child health behaviors among children in treatment for overweight/obesity. Eat Weight Disord. 2022 Jun;27(5):1669-1678. doi: 10.1007/s40519-021-01303-4. Epub 2021 Sep 21.
- Grammer AC, Best JR, Fowler LA, Balantekin KN, Stein RI, Conlon RPK, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. General and Eating Disorder Psychopathology in Relation to Short- and Long-Term Weight Change in Treatment-Seeking Children: A Latent Profile Analysis. Ann Behav Med. 2021 Jun 28;55(7):698-704. doi: 10.1093/abm/kaaa076.
- Fowler LA, Grammer AC, Ray MK, Balantekin KN, Stein RI, Kolko Conlon RP, Welch RR, Perri MG, Epstein LH, Wilfley DE. Examining the interdependence of parent-child dyads: Effects on weight loss and maintenance. Pediatr Obes. 2021 Jan;16(1):e12697. doi: 10.1111/ijpo.12697. Epub 2020 Jul 28.
- Rotman SA, Fowler LA, Ray MK, Stein RI, Hayes JF, Kolko RP, Balantekin KN, Engel A, Saelens BE, Welch RR, Perri MG, Epstein LH, Wilfley DE. Family Encouragement of Healthy Eating Predicts Child Dietary Intake and Weight Loss in Family-Based Behavioral Weight-Loss Treatment. Child Obes. 2020 Apr;16(3):218-225. doi: 10.1089/chi.2019.0119. Epub 2019 Dec 12.
- Wilfley DE, Saelens BE, Stein RI, Best JR, Kolko RP, Schechtman KB, Wallendorf M, Welch RR, Perri MG, Epstein LH. Dose, Content, and Mediators of Family-Based Treatment for Childhood Obesity: A Multisite Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1151-1159. doi: 10.1001/jamapediatrics.2017.2960.
- Balantekin KN, Hayes JF, Sheinbein DH, Kolko RP, Stein RI, Saelens BE, Hurst KT, Welch RR, Perri MG, Schechtman KB, Epstein LH, Wilfley DE. Patterns of Eating Disorder Pathology are Associated with Weight Change in Family-Based Behavioral Obesity Treatment. Obesity (Silver Spring). 2017 Dec;25(12):2115-2122. doi: 10.1002/oby.22028. Epub 2017 Oct 6.
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
2009年10月1日
一次修了 (実際)
2013年3月1日
研究の完了 (実際)
2013年3月1日
試験登録日
最初に提出
2008年9月23日
QC基準を満たした最初の提出物
2008年9月24日
最初の投稿 (見積もり)
2008年9月25日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月23日
QC基準を満たした最後の更新が送信されました
2017年2月20日
最終確認日
2017年2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。