A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Ratings of acceptability intervention
研究概览
简要总结
The purpose of this study is to evaluate whether a behavioral weight loss group in conjunction with a prescribed breakfast can help children between 8 and 12 years of age change their behaviors to help them lose weight and become healthier.
详细描述
The purpose of this application is to evaluate the acceptability and initial efficacy of consumption of an egg breakfast, compared to a cereal breakfast, in the context of Family-based Behavioral Treatment (FBT) with overweight and obese children and their parents. Investigators will randomize 66 parents and their overweight and obese child (85-99.9%BMI) to FBT+egg or FBT+cereal groups. Families will eat their assigned breakfast (eggs or cereal) 5 out of 7 days during the 4 month FBT treatment. However, all other aspects of FBT will be the same in the two groups. Children and parents will complete assessments at three time points; baseline, post-treatment and 4-months post-treatment.
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
- •Children between the ages of 8 and 12 years old;
- •BMI ≥85th% and <100% overweight
- •Children with parents who are willing to attend 16 weekly group sessions and be randomized to either treatment arm;
- •Have at least one parent who is overweight or obese (BMI≥25);
- •Children and parent who endorse liking of both eggs and cereal
- •Parents who speak English at a 5th grade level.
排除标准
- •Children with serious medical conditions that affect their weight;
- •Children taking medication that affect appetite or weight;
- •Children with severe developmental delay or disability that would affect participation;
- •Children or parents with psychological illness that would limit treatment participation;
- •Families who plan to move out of the area within the time frame of the study.
研究组 & 干预措施
Family Based Behavioral Treatment Egg
The FBT+Egg group will participate in group-based FBT and will be assigned to eat eggs a minimum of 5 days a week for breakfast. Families are provided eggs each week to facilitate compliance, along with recipes
干预措施: Family Based Behavioral Treatment (Behavioral)
Family Based Behavioral Treatment Cereal
The FBT+Cereal group will participate in group-based FBT and will be assigned to eat cereal a minimum of 5 days a week for breakfast. Families are provided cereal each week to facilitate compliance.
干预措施: Family Based Behavioral Treatment (Behavioral)
结局指标
主要结局
Ratings of acceptability intervention
时间窗: 4 months
Ratings of liking intervention
时间窗: 4 months
次要结局
- Child weight(8 months)
- Parent weight(8 months)
研究者
Kerri Boutelle
Dr. Kerri Boutelle, Ph.D.
University of California, San Diego