Family Based Treatment for Weight Loss With Breakfast Prescription (FAB)
2017年10月16日 更新者：Kerri Boutelle、University of California, San Diego
A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
66
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
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California
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La Jolla、California、美国、92037
- Center for Healthy Eating and Activity Research
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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:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
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实验性的：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
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The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy.
Treatment is provided in separate parent and child groups.
Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity).
Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention.
Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.
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有源比较器：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.
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The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy.
Treatment is provided in separate parent and child groups.
Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity).
Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention.
Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Ratings of acceptability intervention
大体时间：4 months
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4 months
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Ratings of liking intervention
大体时间：4 months
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child weight
大体时间：8 months
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Measured by Body Mass Index (BMI)
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8 months
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Parent weight
大体时间：8 months
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Measured by Body Mass Index (BMI)
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8 months
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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。
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
- Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.
- Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.
- Layman DK. The role of leucine in weight loss diets and glucose homeostasis. J Nutr. 2003 Jan;133(1):261S-267S. doi: 10.1093/jn/133.1.261S.
- Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year outcomes of behavioral family-based treatment for childhood obesity. Health Psychol. 1994 Sep;13(5):373-83. doi: 10.1037//0278-6133.13.5.373.
- Halton TL, Hu FB. The effects of high protein diets on thermogenesis, satiety and weight loss: a critical review. J Am Coll Nutr. 2004 Oct;23(5):373-85. doi: 10.1080/07315724.2004.10719381.
- Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90.
- Shikany JM, Thomas SE, Henson CS, Redden DT, Heimburger DC. Glycemic index and glycemic load of popular weight-loss diets. MedGenMed. 2006 Jan 25;8(1):22.
- Piech RM, Pastorino MT, Zald DH. All I saw was the cake. Hunger effects on attentional capture by visual food cues. Appetite. 2010 Jun;54(3):579-82. doi: 10.1016/j.appet.2009.11.003. Epub 2009 Nov 13.
- Hagan MM, Wauford PK, Chandler PC, Jarrett LA, Rybak RJ, Blackburn K. A new animal model of binge eating: key synergistic role of past caloric restriction and stress. Physiol Behav. 2002 Sep;77(1):45-54. doi: 10.1016/s0031-9384(02)00809-0.
- Vander Wal JS, Marth JM, Khosla P, Jen KL, Dhurandhar NV. Short-term effect of eggs on satiety in overweight and obese subjects. J Am Coll Nutr. 2005 Dec;24(6):510-5. doi: 10.1080/07315724.2005.10719497.
- Layman DK, Walker DA. Potential importance of leucine in treatment of obesity and the metabolic syndrome. J Nutr. 2006 Jan;136(1 Suppl):319S-23S. doi: 10.1093/jn/136.1.319S.
- Blouet C, Jo YH, Li X, Schwartz GJ. Mediobasal hypothalamic leucine sensing regulates food intake through activation of a hypothalamus-brainstem circuit. J Neurosci. 2009 Jul 1;29(26):8302-11. doi: 10.1523/JNEUROSCI.1668-09.2009.
- Zhang Y, Guo K, LeBlanc RE, Loh D, Schwartz GJ, Yu YH. Increasing dietary leucine intake reduces diet-induced obesity and improves glucose and cholesterol metabolism in mice via multimechanisms. Diabetes. 2007 Jun;56(6):1647-54. doi: 10.2337/db07-0123. Epub 2007 Mar 14.
- Cummings DM, Henes S, Kolasa KM, Olsson J, Collier D. Insulin resistance status: predicting weight response in overweight children. Arch Pediatr Adolesc Med. 2008 Aug;162(8):764-8. doi: 10.1001/archpedi.162.8.764.
- Vander Wal JS, Gupta A, Khosla P, Dhurandhar NV. Egg breakfast enhances weight loss. Int J Obes (Lond). 2008 Oct;32(10):1545-51. doi: 10.1038/ijo.2008.130. Epub 2008 Aug 5.
- Lomenick JP, Melguizo MS, Mitchell SL, Summar ML, Anderson JW. Effects of meals high in carbohydrate, protein, and fat on ghrelin and peptide YY secretion in prepubertal children. J Clin Endocrinol Metab. 2009 Nov;94(11):4463-71. doi: 10.1210/jc.2009-0949. Epub 2009 Oct 9.
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
2014年1月1日
初级完成 (实际的)
2017年9月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2014年10月28日
首先提交符合 QC 标准的
2015年6月8日
首次发布 (估计)
2015年6月9日
研究记录更新
最后更新发布 (实际的)
2017年10月18日
上次提交的符合 QC 标准的更新
2017年10月16日
最后验证
2017年10月1日
更多信息
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