Parents as the Agent of Change for Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Parent-only Group (Behavioral)
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.
干预措施: Parent + Child Group (Behavioral)
结局指标
主要结局
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
时间窗: 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.
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
时间窗: 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.
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
时间窗: 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.
次要结局
- To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality(At post-treatment 18-month follow-up visit)
- To compare effect of parent-only treatment versus parent + child treatment on parenting style(At post-treatment 18-month follow-up visit)
- To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss(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(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(At post-treatment 18-month follow-up visit)
- To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment(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(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(A 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(At post-treatment 18-month follow-up visit)
- To compare effect of parent-only treatment versus parent + child treatment on parent's adherence(At post-treatment 18-month follow-up visit)
- To evaluate the predictors of success in childhood obesity treatments by evaluating compliance(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(At post-treatment 18-month follow-up visit)
- To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style(At post-treatment 18-month follow-up visit)
研究者
Kerri Boutelle
Associate Professor
University of California, San Diego