NCT00944099

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

July 21, 2009

Last Update Submit

April 3, 2018

Conditions

Keywords

intervention studiesfeeding behavioreating frequencyweight lossdietary intake

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

EXPERIMENTAL

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

Behavioral: Behavioral weight loss intervention

Three Meals

EXPERIMENTAL

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

Behavioral: Behavioral weight loss intervention

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

GrazingThree Meals

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Healthy Eating and Acitivty Laboratory, University of Tennessee

Knoxville, Tennessee, 37996-1920, United States

Location

MeSH Terms

Conditions

OverweightObesityFeeding BehaviorWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorBody Weight Changes

Study Officials

  • Jessica L Bachman, MS, MPH, RD

    University of Tennessee

    PRINCIPAL INVESTIGATOR
  • Hollie A Raynor, PhD, RD

    University of Tennessee

    STUDY CHAIR

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

Locations