- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00944099
Lifestyle, Eating, and Activity Patterns (LEAP)
April 3, 2018 updated by: Hollie Raynor, The University of Tennessee, Knoxville
Eating Frequency Prescription for a Behavioral Weigh Loss Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
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Knoxville, Tennessee, United States, 37996-1920
- Healthy Eating and Acitivty Laboratory, University of Tennessee
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Grazing
participants will be given an eating frequency prescription to eat every 2 to 3 hours
|
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
|
|
EXPERIMENTAL: Three Meals
participants will be given an eating frequency prescription of eating 3 meals per day
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
eating occasions per day
Time Frame: 0, 3, and 6 months
|
0, 3, and 6 months
|
|
hunger and reinforcing value of food
Time Frame: 0, 3, and 6 months
|
0, 3, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
energy and percent calories from fat intake
Time Frame: 0, 3, and 6 months
|
0, 3, and 6 months
|
|
body weight, percent body fat, percent fat free mass
Time Frame: 0, 3, and 6 months
|
0, 3, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jessica L Bachman, MS, MPH, RD, University of Tennessee
- Study Chair: Hollie A Raynor, PhD, RD, University of Tennessee
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
July 21, 2009
First Submitted That Met QC Criteria
July 22, 2009
First Posted (ESTIMATE)
July 23, 2009
Study Record Updates
Last Update Posted (ACTUAL)
April 5, 2018
Last Update Submitted That Met QC Criteria
April 3, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHA 09PRE2020150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.