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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
152
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
La Jolla、California、美国、92093
- UCSD Center for Healthy Eating and Activity Research (CHEAR)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 12年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
其他名称：
|
|
有源比较器：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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
大体时间：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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kerri Boutelle, PhD、UCSD
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2010年8月17日
首先提交符合 QC 标准的
2010年9月8日
首次发布 (估计)
2010年9月9日
研究记录更新
最后更新发布 (估计)
2015年12月2日
上次提交的符合 QC 标准的更新
2015年11月30日
最后验证
2015年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.