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Lifestyle, Eating, and Activity Patterns (LEAP)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00944099
First received: July 21, 2009
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: Behavioral weight loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eating Frequency Prescription for a Behavioral Weigh Loss Intervention

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • eating occasions per day [ Time Frame: 0, 3, and 6 months ] [ Designated as safety issue: No ]
  • hunger and reinforcing value of food [ Time Frame: 0, 3, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • energy and percent calories from fat intake [ Time Frame: 0, 3, and 6 months ] [ Designated as safety issue: No ]
  • body weight, percent body fat, percent fat free mass [ Time Frame: 0, 3, and 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Grazing
participants will be given an eating frequency prescription to eat every 2 to 3 hours
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
Experimental: Three Meals
participants will be given an eating frequency prescription of eating 3 meals per day
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944099

Locations
United States, Tennessee
Healthy Eating and Acitivty Laboratory, University of Tennessee
Knoxville, Tennessee, United States, 37996-1920
Sponsors and Collaborators
University of Tennessee
American Heart Association
Investigators
Principal Investigator: Jessica L Bachman, MS, MPH, RD University of Tennessee
Study Chair: Hollie A Raynor, PhD, RD University of Tennessee
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT00944099     History of Changes
Other Study ID Numbers: AHA 09PRE2020150
Study First Received: July 21, 2009
Last Updated: November 14, 2012
Health Authority: United States: American Heart Association

Keywords provided by University of Tennessee:
intervention studies
feeding behavior
eating frequency
weight loss
dietary intake

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014