Healthy Eating Patterns During a Lifestyle Intervention (HEP)

June 17, 2023 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

30

Phase

  • 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

    • 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

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
Intervention / Treatment
Experimental: Three Meal
Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.
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.
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

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

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.

Investigators

  • 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)

August 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimated)

September 10, 2012

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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