Healthy Eating Patterns During a Lifestyle Intervention (HEP)

June 5, 2026 updated by: Hollie Raynor, The University of Tennessee, Knoxville
The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Little intervention research has been conducted to examine the influence of eating frequency (EF) on weight loss. It has been hypothesized an increased EF improves appetite control, assisting with better regulation of energy intake, thus decreasing body mass index. Unfortunately, outcomes have not shown greater appetite control with increased EF. Instead, trends favor a lower EF reducing energy intake thereby producing greater weight loss than a higher eating frequency. Thus, a lower eating frequency may lower energy intake via behavioral mechanisms. At thit time no research has examined the behavioral mechanisms that may mediate the relationship between a lower eating frequency and superior adherence to an energy-restricted diet.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • Healthy Eating and Activity Laboratory, University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Three Meal
Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.
Behavioral: Eating Frequency
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).
Experimental: Grazing
Participants in the increased eating frequency condition will be instructed to eat > 100 kcals every 2-3 hours.
Behavioral: Eating Frequency
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diet
Time Frame: 0 and 8 weeks
Diet (eating frequency, kilocalories, macronutrients)
0 and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ecological Momentary Assessment (EMA)
Time Frame: 0 and 8 weeks
To evaluate the behavioral mechanisms of eating frequency, PalmPilot-based EMA will be used to collect real-time information on consumption cues.
0 and 8 weeks
Anthropometrics
Time Frame: 0 and 8 weeks
Height (0 weeks only), weight and body mass index
0 and 8 weeks
Binge Eating
Time Frame: 0 and 8 weeks
Assessed by the Eating Disorder Examination-Questionnaire (EDE-Q), which is a 36-item questionnaire derived from the Eating Disorders Examination interview.
0 and 8 weeks
Physical Activity
Time Frame: 0 and 8 weeks
Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.
0 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Tennessee, Knoxville

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hollie A Raynor, PhD, RD, University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTK IRB# FWA 6629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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