Changes in Food Reinforcement During Obesity Treatment

NCT00200291 | Completed

• 1 other identifier: 3U01DK067861-02S1
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Reinforcing value of low- and high-fat food

  6 months

Secondary Outcomes (1)

• diet changes and weight loss

  6 months

Study Arms (2)

1

EXPERIMENTAL

Behavioral: hypocaloric low-fat diet

Behavioral: hypocaloric, low-fat diet

2

PLACEBO COMPARATOR

Behavioral: hypocaloric, low-fat diet

Behavioral: hypocaloric, low-fat diet

Interventions

hypocaloric, low-fat diet BEHAVIORAL

hypocaloric, low-fat diet

1; 2

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants from main parent study - PRIDE

You may not qualify if:

• Allergic to foods in investigation

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hollie A Raynor, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 20, 2012

Record last verified: 2007-12

Locations

US (1)