Family Based Treatment for Weight Loss With Breakfast Prescription

Obesity Clinical Trial

— FAB  

Official title:

A Pilot Study Examining the Impact of Eggs for Breakfast on Weight Loss and Hunger in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467036
• Other study ID #: 131519
• Secondary ID: 20133198
• Status: Completed
• Phase: N/A
• First received: October 28, 2014
• Last updated: October 16, 2017
• Start date: January 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Children between the ages of 8 and 12 years old;

2. BMI =85th% and <100% overweight

3. Children with parents who are willing to attend 16 weekly group sessions and be randomized to either treatment arm;

4. Have at least one parent who is overweight or obese (BMI=25);

5. Children and parent who endorse liking of both eggs and cereal

6. Parents who speak English at a 5th grade level.

Exclusion Criteria:

1. Children with serious medical conditions that affect their weight;

2. Children taking medication that affect appetite or weight;

3. Children with severe developmental delay or disability that would affect participation;

4. Children or parents with psychological illness that would limit treatment participation;

5. Families who plan to move out of the area within the time frame of the study.

Related Conditions & MeSH terms

• Body Weight
• Childhood Obesity
• Hyperphagia
• Obesity
• Overeating
• Overweight
• Pediatric Obesity
• Weight
• Weight Loss

Intervention

Behavioral:
• Family Based Behavioral Treatment
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.

Locations

Country	Name	City	State
United States	Center for Healthy Eating and Activity Research	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	American Egg Board

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. Epub 2006 May 30. — View Citation

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. — View Citation

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. — View Citation

Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21. — View Citation

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. — View Citation

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. Review. — View Citation

Holt SH, Miller JC, Petocz P, Farmakalidis E. A satiety index of common foods. Eur J Clin Nutr. 1995 Sep;49(9):675-90. — View Citation

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. Review. — View Citation

Layman DK. The role of leucine in weight loss diets and glucose homeostasis. J Nutr. 2003 Jan;133(1):261S-267S. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Mar 14. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratings of acceptability intervention		4 months
Primary	Ratings of liking intervention		4 months
Secondary	Child weight	Measured by Body Mass Index (BMI)	8 months
Secondary	Parent weight	Measured by Body Mass Index (BMI)	8 months

External Links

•   Center for Healthy Eating and Activity Research