Lifestyle, Eating, and Activity Patterns

Obesity Clinical Trial

— LEAP  

Official title:

Eating Frequency Prescription for a Behavioral Weigh Loss Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944099
• Other study ID #: AHA 09PRE2020150
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: April 3, 2018
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2018
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention.

Description:

Previous observational and experimental research suggests that increased eating frequency is related to lower weight, body mass index (BMI)and body fatness. It is proposed that eating frequently during the day reduces overall energy consumed by preventing the development of excessive hunger. As elevated hunger increases the reinforcing value of food, and greater intake occurs when the reinforcing value of food increases, eating frequently during the day may be a dietary strategy that can aid with reducing energy intake and improving weight loss during a behavioral weight control program. Therefore, the purpose of this proposed research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. Participants will be randomized to 1 of 2 conditions: 1) a condition in which participants will be given an eating frequency prescription to eat every 2 to 3 hours (Grazing); or 2) a condition in which participants will be given an eating frequency prescription of eating 3 meals per day (Three Meals). Both conditions will receive an identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week. Additionally, both conditions will receive an identical state-of-the-art, 6-month, behavioral weight loss program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• body mass index (BMI) between 27 and 45 kg/m2

Exclusion Criteria:

• report a heart condition, chest pain during periods of activity or rest, or loss of consciousness

• report being unable to walk 1/4 mile without stopping

• report major psychological disease or organic brain syndromes

• report a diagnosis of type I or type II diabetes

• are currently participating in a weight loss program, are taking weight loss medication, have had surgery for weight loss, or have lost > 5% of their body weight in the past 6 months

• are currently participating in a program that manipulates their eating habits

• intent to move outside of the East Tennessee area within the time frame of the intervention

• are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the intervention

• are unwilling to attend group intervention meetings, assessments, or complete a food diary for the duration of the study

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Behavioral weight loss intervention
both conditions will receive an identical dietary prescription, low-calorie and less than 30% calories from fat and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week during a 6 month behavioral weight loss program

Locations

Country	Name	City	State
United States	Healthy Eating and Acitivty Laboratory, University of Tennessee	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eating occasions per day		0, 3, and 6 months
Primary	hunger and reinforcing value of food		0, 3, and 6 months
Secondary	energy and percent calories from fat intake		0, 3, and 6 months
Secondary	body weight, percent body fat, percent fat free mass		0, 3, and 6 months