NCT02467036

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

October 28, 2014

Last Update Submit

October 16, 2017

Conditions

ObesityOverweightOvereatingWeightChildhood Obesity

Keywords

overweight childrenoverweight parentseating in the absence of hungerfamilies with overweight childbmibody mass indextreatmentbehavioral treatmentfamily based treatmentexperimentsinterventionpsychophysiological response to food cues

Outcome Measures

Primary Outcomes (2)

  • Ratings of acceptability intervention

    4 months

  • Ratings of liking intervention

    4 months

Secondary Outcomes (2)

  • Child weight

    8 months

  • Parent weight

    8 months

Study Arms (2)

Family Based Behavioral Treatment Egg

EXPERIMENTAL

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

Behavioral: Family Based Behavioral Treatment

Family Based Behavioral Treatment Cereal

ACTIVE COMPARATOR

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.

Behavioral: Family Based Behavioral Treatment

Interventions

Family Based Behavioral TreatmentBEHAVIORAL

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.

Family Based Behavioral Treatment CerealFamily Based Behavioral Treatment Egg

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Healthy Eating and Activity Research

La Jolla, California, 92037, United States

Location

Related Publications (17)

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

    PMID: 8646260BACKGROUND

  • 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.

    PMID: 7805631BACKGROUND

  • 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.

    PMID: 16915152BACKGROUND

  • 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.

    PMID: 15466943BACKGROUND

  • 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.

    PMID: 19914320BACKGROUND

  • 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.

    PMID: 12213501BACKGROUND

  • 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.

    PMID: 16735482BACKGROUND

  • 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.

    PMID: 3212049BACKGROUND

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

    PMID: 7498104BACKGROUND

  • 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.

    PMID: 16373948BACKGROUND

  • 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.

    PMID: 16365106BACKGROUND

  • 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.

    PMID: 19571121BACKGROUND

  • 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.

    PMID: 12514305BACKGROUND

  • 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.

    PMID: 17360978BACKGROUND

  • 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.

    PMID: 18678809BACKGROUND

  • 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.

    PMID: 18679412BACKGROUND

  • 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.

    PMID: 19820013BACKGROUND

MeSH Terms

Conditions

ObesityOverweightHyperphagiaBody WeightPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Kerri Boutelle, Ph.D.

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Kerri Boutelle, Ph.D.

Study Record Dates

First Submitted

October 28, 2014

First Posted

June 9, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)