NCT01682317

Brief Summary

The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

6.4 years

First QC Date

September 5, 2012

Last Update Submit

April 1, 2025

Conditions

Keywords

eating frequency

Outcome Measures

Primary Outcomes (1)

  • Diet

    Diet (eating frequency, kilocalories, macronutrients)

    0 and 8 weeks

Secondary Outcomes (4)

  • Ecological Momentary Assessment (EMA)

    0 and 8 weeks

  • Anthropometrics

    0 and 8 weeks

  • Binge Eating

    0 and 8 weeks

  • Physical Activity

    0 and 8 weeks

Study Arms (2)

Three Meal

EXPERIMENTAL

Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.

Behavioral: Eating Frequency

Grazing

EXPERIMENTAL

Participants in the increased eating frequency condition will be instructed to eat \> 100 kcals every 2-3 hours.

Behavioral: Eating Frequency

Interventions

Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, \< 30% energy from fat dietary prescription, and a physical activity goal of 200 minutes/week. Participants will be randomized to one of two conditions differing in EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).

GrazingThree Meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 65 years
  • healthy overweight and obese men and women
  • body mass index (BMI) between 27 and 45 kg/m squared

You may not qualify if:

  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR- Q)
  • report being unable to walk for 2 blocks (1/4 mile) without stopping
  • are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
  • diagnosed with type 1 or 2 diabetes
  • have had bariatric surgery or are planning to have bariatric surgery in the next 4 months
  • intend to move outside of the metropolitan area within the time frame of the investigation
  • are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Hollie A Raynor, PhD, RD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

August 1, 2012

Primary Completion

December 31, 2018

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-04

Locations