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Lifestyle, Eating, and Activity Patterns (LEAP)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight loss intervention
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring intervention studies, feeding behavior, eating frequency, weight loss, dietary intake

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Healthy Eating and Acitivty Laboratory, University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Grazing

Three Meals

Arm Description

participants will be given an eating frequency prescription to eat every 2 to 3 hours

participants will be given an eating frequency prescription of eating 3 meals per day

Outcomes

Primary Outcome Measures

eating occasions per day
hunger and reinforcing value of food

Secondary Outcome Measures

energy and percent calories from fat intake
body weight, percent body fat, percent fat free mass

Full Information

First Posted
July 21, 2009
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00944099
Brief Title
Lifestyle, Eating, and Activity Patterns
Acronym
LEAP
Official Title
Eating Frequency Prescription for a Behavioral Weigh Loss Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
intervention studies, feeding behavior, eating frequency, weight loss, dietary intake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grazing
Arm Type
Experimental
Arm Description
participants will be given an eating frequency prescription to eat every 2 to 3 hours
Arm Title
Three Meals
Arm Type
Experimental
Arm Description
participants will be given an eating frequency prescription of eating 3 meals per day
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
eating occasions per day
Time Frame
0, 3, and 6 months
Title
hunger and reinforcing value of food
Time Frame
0, 3, and 6 months
Secondary Outcome Measure Information:
Title
energy and percent calories from fat intake
Time Frame
0, 3, and 6 months
Title
body weight, percent body fat, percent fat free mass
Time Frame
0, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica L Bachman, MS, MPH, RD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor, PhD, RD
Organizational Affiliation
University of Tennessee
Official's Role
Study Chair
Facility Information:
Facility Name
Healthy Eating and Acitivty Laboratory, University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996-1920
Country
United States

12. IPD Sharing Statement

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Lifestyle, Eating, and Activity Patterns

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