Changes in Food Reinforcement During Obesity Treatment

NCT ID: NCT00200291

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-10-31

Brief Summary

The reinforcing value of food, or how much a person "wants" a food, is an important determinant of food intake. Thus far, food reinforcement has only been studied in laboratory settings, and no studies have examined whether the reinforcing value of food is altered when dietary changes are made. The chronic deprivation that occurs when a low-calorie, low-fat diet is implemented for weight loss may increase the reinforcing value of all foods, but particularly for restricted high-fat foods. Greater increases in the reinforcing value of high-fat foods relative to low-fat foods may be detrimental for sustaining newly adopted eating behaviors that produce weight loss, whereas greater increases in the reinforcing value of low-fat foods relative to high-fat foods may aid in maintaining healthy eating behaviors. The aim of this application is to measure food reinforcement in a clinical setting to determine if food reinforcement changes when a traditional weight loss diet is prescribed. For this ancillary study, 147 volunteers will be recruited from the 165 overweight and obese women participating in the Program to Reduce Incontinence by Diet and Exercise (PRIDE) at The Miriam Hospital. As part of PRIDE, these participants will be randomized in a 2-to-1 ratio to either a 6-month weight loss intervention or usual care. Assessments of food reinforcement, dietary intake, and weight will occur at 0 and 6 months. Given that the intervention group changes their diet relative to the usual care group, it is hypothesized: 1) the intervention group will have greater increases in the reinforcing value of both high- and low-fat foods than the usual care group from 0 to 6 months; and 2) within the intervention group, decreases in frequency of consumption of high-fat foods will be related to increases in the reinforcing value of high-fat foods from 0 to 6 months. These results will lead to a novel line of research, examining the relationship between food reinforcement and weight loss maintenance, so that diets can be designed to promote changes in food reinforcement that aid in sustaining dietary changes and weight loss.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

Behavioral: hypocaloric low-fat diet

Group Type: EXPERIMENTAL

hypocaloric, low-fat diet

Intervention Type: BEHAVIORAL

hypocaloric, low-fat diet

2

Behavioral: hypocaloric, low-fat diet

Group Type: PLACEBO_COMPARATOR

hypocaloric, low-fat diet

Intervention Type: BEHAVIORAL

hypocaloric, low-fat diet

Interventions

hypocaloric, low-fat diet

hypocaloric, low-fat diet

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants from main parent study - PRIDE

Exclusion Criteria

• Allergic to foods in investigation

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hollie A Raynor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

The Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

3U01DK067861-02S1

Identifier Type: NIH

Identifier Source: org_study_id

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