Healthy Eating Patterns During a Lifestyle Intervention
HEP
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2012
Longer than P75 for not_applicable obesity
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
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 3, 2025
April 1, 2025
6.4 years
September 5, 2012
April 1, 2025
Conditions
Keywords
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
EXPERIMENTALParticipants in this condition will be instructed to limit their number of eating frequency to three meals per day.
Grazing
EXPERIMENTALParticipants in the increased eating frequency condition will be instructed to eat \> 100 kcals every 2-3 hours.
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).
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hollie A Raynor, PhD, RD
University of Tennessee
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