Translating Habituation Research to Interventions for Pediatric Obesity

NCT01208870 | Completed Results

• 2 other identifiers: 1083316-1-522055U01DK088380
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

Conditions

Pediatric Obesity; Habituation

Outcome Measures

Primary Outcomes (2)

• Change of Child Body Composition

  Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.

  Baseline to 6 months

• Change Parent Body Composition

  Parent Body Mass Index (kg/m\^2) difference from baseline to 6 months

  Baseline to 6 months

Secondary Outcomes (4)

• Change in Dietary Intake of Calories

  Baseline to 6 months

• Change in Parent Delay Discounting

  Baseline to 6 months

• Change in Child Delay Discounting

  Baseline to 6 months

• Changes in Variety Measures

  Baseline to 6 months

Study Arms (2)

Variety Group

EXPERIMENTAL

Traditional family based weight control treatment program with components to reduce variety of high energy dense foods incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.

Behavioral: Variety Group; Behavioral: Nutrition Education Control

Nutrition Education Control

EXPERIMENTAL

Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 behavioral intervention sessions.

Behavioral: Nutrition Education Control

Interventions

Variety Group BEHAVIORAL

The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.

Variety Group

Nutrition Education Control BEHAVIORAL

The intervention will consist of our traditional family based weight control intervention.

Nutrition Education Control; Variety Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 8-12 years of age
• At or above 85th BMI percentile
• Children must eat almost all meals with the exception of school lunch with the family.
• Overweight parent

You may not qualify if:

• Children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods.
• Families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders.
• The parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes.
• Children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

Buffalo, New York, 14214, United States

Location

Related Publications (3)

• Epstein LH, Kilanowski C, Paluch RA, Raynor H, Daniel TO. Reducing variety enhances effectiveness of family-based treatment for pediatric obesity. Eat Behav. 2015 Apr;17:140-3. doi: 10.1016/j.eatbeh.2015.02.001. Epub 2015 Feb 13.

  PMID: 25706950 DERIVED

• Epstein LH, Fletcher KD, O'Neill J, Roemmich JN, Raynor H, Bouton ME. Food characteristics, long-term habituation and energy intake. Laboratory and field studies. Appetite. 2013 Jan;60(1):40-50. doi: 10.1016/j.appet.2012.08.030. Epub 2012 Oct 22.

  PMID: 23085682 DERIVED

• Epstein LH, Carr KA, Cavanaugh MD, Paluch RA, Bouton ME. Long-term habituation to food in obese and nonobese women. Am J Clin Nutr. 2011 Aug;94(2):371-6. doi: 10.3945/ajcn.110.009035. Epub 2011 May 18.

  PMID: 21593492 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Two different measures were used to assess variety and calorie intake.

Results Point of Contact

• Title: Leonard H. Epstein, Ph.D.
• Organization: SUNY Buffalo

lhenet@buffalo.edu

716-829-3400

Study Officials

• Leonard H. Epstein, Ph.D.

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: October 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 6, 2020
• Results First Posted: October 2, 2017

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)