Lifestyle, Eating, and Activity Patterns
LEAP
Eating Frequency Prescription for a Behavioral Weigh Loss Intervention
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 5, 2018
April 1, 2018
1.9 years
July 21, 2009
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
eating occasions per day
0, 3, and 6 months
hunger and reinforcing value of food
0, 3, and 6 months
Secondary Outcomes (2)
energy and percent calories from fat intake
0, 3, and 6 months
body weight, percent body fat, percent fat free mass
0, 3, and 6 months
Study Arms (2)
Grazing
EXPERIMENTALparticipants will be given an eating frequency prescription to eat every 2 to 3 hours
Three Meals
EXPERIMENTALparticipants will be given an eating frequency prescription of eating 3 meals per day
Interventions
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
Eligibility Criteria
You may qualify if:
- body mass index (BMI) between 27 and 45 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Tennessee, Knoxvillelead
- American Heart Associationcollaborator
Study Sites (1)
Healthy Eating and Acitivty Laboratory, University of Tennessee
Knoxville, Tennessee, 37996-1920, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica L Bachman, MS, MPH, RD
University of Tennessee
- STUDY CHAIR
Hollie A Raynor, PhD, RD
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
January 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
April 5, 2018
Record last verified: 2018-04