Parents as the Agent of Change for Childhood Obesity (PAAC)
2015年11月30日 更新者：Kerri Boutelle、University of California, San Diego
The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.
調査の概要
詳細な説明
This study is a randomized clinical trial in which 150 overweight 8-12 year old children and their parent will be randomly assigned by the gender of the child to one of two conditions; a parent-only intervention or a parent + child intervention.
Both treatment arms will provide behavioral treatment for childhood obesity for 5 months, and participants will be followed for 18-months post-treatment.
Assessments will occur at baseline, immediately post-treatment, 6-12- and 18-months post-treatment.
The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity (parent-only), and to evaluate the cost effectiveness compared to the current gold standard treatment of parent + child.
Results of these studies will be utilized as evidence to recommend changes in the standard treatment for childhood obesity.
This program of research is critical for exploring and developing interventions that mobilize parents to intervene with their overweight and obese children.
The timing of this research is optimal given the increase in childhood obesity in the United States, and the need for disseminative intervention and prevention programs.
研究の種類
介入
入学 (実際)
152
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
-
-
California
-
La Jolla、California、アメリカ、92093
- UCSD Center for Healthy Eating and Activity Research (CHEAR)
-
-
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
8年～12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:
- Overweight child 8-12 years of age and above the 95th% for age and gender
- An overweight (BMI > 25) parent willing to participate and attend all treatment meetings
- Eligible parent who can read at a minimum of an 8th grade level
- Family willing to commit to 5 months of treatment attendance, and follow-up for 18 months post-treatment.
Exclusion Criteria:
- Major child psychiatric disorder diagnoses
- Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed (self-report)
- Family with restrictions on types of food, such as food allergies, religious, or ethnic practices that limit the foods available in the home
- Child with physical difficulties that limit the ability to exercise
- Child with an active eating disorder (based on EDE interview)
- Families where children or parents are involved in swimming or weight training more than 5 hours per week
- Major parent psychiatric disorder
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 |
|---|---|
|
実験的：Parent-only Group
Treatment will be administered to parents of the overweight child.
Parent-only group treatment will include all of the same skills and techniques to promote weight loss, but the information will be delivered only to the parent.
Participation of the children assigned to the parent-only treatment arm will be limited to the baseline and follow-up assessments.
|
Parent-only group will include the same skills and techniques to promote weight loss as given to the parent + child group, but the information will be delivered only to the parent.
Parent group will be compared to the parent group of the parent + child treatment arm.
The focus will be on implementing skills learned to assist the child in weight management.
The treatment length is set for 12 weekly meetings and bi-monthly meetings during months 4 and 5.
Each group session will be 60-min including weigh-ins.
Group meetings focus on behavior change, weight loss, healthy eating and activity for the overweight child and parent.
他の名前：
|
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アクティブコンパレータ：Parent + child Group
The treatment for participants in the parent + child arm will be administered in two separate groups, one for the parents and one for the child.
|
The treatment for participants in the parent + child group will be administered in two separate groups, one for the parents and one for the child.
Treatment will include the same skills and techniques to promote weight loss as given to the parent-only group, but the information will be delivered to both the parent and child.
The treatment length, session schedule, treatment content and follow-up assessments are same as the parent-only group.
他の名前：
|
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 |
|---|---|---|
|
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
時間枠：At post-treatment visit (after 6-month treatment)
|
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment immediately following treatment.
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
時間枠：At post-treatment 6-month follow-up visit
|
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 6-month follow-up visit.
|
At post-treatment 6-month follow-up visit
|
|
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
時間枠：At post-treatment 18-month follow-up visit
|
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 18-month follow-up visit.
|
At post-treatment 18-month follow-up visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
時間枠：At post-treatment visit (after 6-month treatment)
|
We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment visit (after 5-month treatment).
|
At post-treatment visit (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
時間枠：At post-treatment (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaire measures specific for child and parent.
|
At post-treatment (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
時間枠：At post-treatment visit (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment visit (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
時間枠：At post-treatment visit (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment visit (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
時間枠：At post-treatment visit (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment visit (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
時間枠：At post-treatment visit (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by group attendance and adherence to behavior recommendations.
|
At post-treatment visit (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on parenting style
時間枠：At post-treatment visit (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment visit (after 6-month treatment)
|
|
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
時間枠：At post-treatment visit (after 6-month treatment)
|
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
時間枠：At post-treatment visit (after 6-month treatment)
|
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
時間枠：At post-treatment visit (after 6-month treatment)
|
Compliance will be measured by group attendance and adherence to behavior recommendations.
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
時間枠：At post-treatment visit (after 6-month treatment)
|
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
時間枠：At post-treatment visit (after 6-month treatment)
|
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
時間枠：At post-treatment visit (after 6-month treatment)
|
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
|
At post-treatment visit (after 6-month treatment)
|
|
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
時間枠：At post-treatment 6-month follow-up visit
|
We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment 6-month follow-up visit.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaire measures specific for child and parent.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
時間枠：At post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaire measures specific for child and parent.
|
At post-treatment 18-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
時間枠：At post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 18-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
時間枠：At post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 18-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
時間枠：A post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
A post-treatment 18-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by group attendance and adherence to behavior recommendations.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
時間枠：At post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by group attendance and adherence to behavior recommendations.
|
At post-treatment 18-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on parenting style
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on parenting style
時間枠：At post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment.
The effect will be measured by assessing questionnaires specific for child and parent.
|
At post-treatment 18-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
時間枠：At post-treatment 6-month follow-up visit
|
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
|
At post-treatment 6-month follow-up visit
|
|
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
時間枠：At post-treatment 18-month follow-up visit
|
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
|
At post-treatment 18-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
時間枠：At post-treatment 6-month follow-up visit
|
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
|
At post-treatment 6-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
時間枠：At post-treatment 18-month follow-up visit
|
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
|
At post-treatment 18-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
時間枠：At post-treatment 6-month follow-up visit
|
Compliance will be measured by group attendance and adherence to behavior recommendations.
|
At post-treatment 6-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
時間枠：At post-treatment 18-month follow-up visit
|
Compliance will be measured by group attendance and adherence to behavior recommendations.
|
At post-treatment 18-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
時間枠：At post-treatment 6-month follow-up visit
|
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
|
At post-treatment 6-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
時間枠：At post-treatment 18-month follow-up visit
|
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
|
At post-treatment 18-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
時間枠：At post-treatment 6-month follow-up visit
|
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
|
At post-treatment 6-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
時間枠：At post-treatment 18-month follow-up visit
|
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
|
At post-treatment 18-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
時間枠：At post-treatment 6-month follow-up visit
|
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
|
At post-treatment 6-month follow-up visit
|
|
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
時間枠：At post-treatment 18-month follow-up visit
|
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
|
At post-treatment 18-month follow-up visit
|
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：Kerri Boutelle, PhD、UCSD
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
- Faith MS, Scanlon KS, Birch LL, Francis LA, Sherry B. Parent-child feeding strategies and their relationships to child eating and weight status. Obes Res. 2004 Nov;12(11):1711-22. doi: 10.1038/oby.2004.212.
- Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based treatment for obese children. JAMA. 1990 Nov 21;264(19):2519-23.
- Bauer KW, Nelson MC, Boutelle KN, Neumark-Sztainer D. Parental influences on adolescents' physical activity and sedentary behavior: longitudinal findings from Project EAT-II. Int J Behav Nutr Phys Act. 2008 Feb 26;5:12. doi: 10.1186/1479-5868-5-12. Erratum In: Int J Behav Nutr Phys Act. 2011;8:12.
- Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Epstein LH, Wing RR, Steranchak L, Dickson B, Michelson J. Comparison of family-based behavior modification and nutrition education for childhood obesity. J Pediatr Psychol. 1980 Mar;5(1):25-36. doi: 10.1093/jpepsy/5.1.25. No abstract available.
- Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. doi: 10.1542/peds.109.5.e81. Erratum In: Pediatrics 2002 Jun;109(6):1195.
- Birch LL, Davison KK. Family environmental factors influencing the developing behavioral controls of food intake and childhood overweight. Pediatr Clin North Am. 2001 Aug;48(4):893-907. doi: 10.1016/s0031-3955(05)70347-3.
- Clark HR, Goyder E, Bissell P, Blank L, Peters J. How do parents' child-feeding behaviours influence child weight? Implications for childhood obesity policy. J Public Health (Oxf). 2007 Jun;29(2):132-41. doi: 10.1093/pubmed/fdm012. Epub 2007 Apr 18.
- Kang Sim DE, Strong DR, Manzano MA, Rhee KE, Boutelle KN. Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. Pediatr Obes. 2020 Jun;15(6):e12622. doi: 10.1111/ijpo.12622. Epub 2020 Feb 12.
- Eichen DM, Strong DR, Rhee KE, Rock CL, Crow SJ, Epstein LH, Wilfley DE, Boutelle KN. Change in eating disorder symptoms following pediatric obesity treatment. Int J Eat Disord. 2019 Mar;52(3):299-303. doi: 10.1002/eat.23015. Epub 2019 Jan 14.
- Boutelle KN, Rhee KE, Liang J, Braden A, Douglas J, Strong D, Rock CL, Wilfley DE, Epstein LH, Crow SJ. Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jul 1;171(7):622-628. doi: 10.1001/jamapediatrics.2017.0651.
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
2010年11月1日
一次修了 (実際)
2015年7月1日
研究の完了 (実際)
2015年7月1日
試験登録日
最初に提出
2010年8月17日
QC基準を満たした最初の提出物
2010年9月8日
最初の投稿 (見積もり)
2010年9月9日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年12月2日
QC基準を満たした最後の更新が送信されました
2015年11月30日
最終確認日
2015年11月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 071669
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。