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Healthy Eating Patterns During a Lifestyle Intervention (HEP)

Primary Purpose

Obesity, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eating Frequency
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring eating frequency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Healthy Eating and Activity Laboratory, University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Three Meal

Grazing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Diet
Diet (eating frequency, kilocalories, macronutrients)

Secondary Outcome Measures

Ecological Momentary Assessment (EMA)
To evaluate the behavioral mechanisms of eating frequency, PalmPilot-based EMA will be used to collect real-time information on consumption cues.
Anthropometrics
Height (0 weeks only), weight and body mass index
Binge Eating
Assessed by the Eating Disorder Examination-Questionnaire (EDE-Q), which is a 36-item questionnaire derived from the Eating Disorders Examination interview.
Physical Activity
Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.

Full Information

First Posted
September 5, 2012
Last Updated
June 17, 2023
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT01682317
Brief Title
Healthy Eating Patterns During a Lifestyle Intervention
Acronym
HEP
Official Title
Healthy Eating Patterns During a Lifestyle Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
eating frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Three Meal
Arm Type
Experimental
Arm Description
Participants in this condition will be instructed to limit their number of eating frequency to three meals per day.
Arm Title
Grazing
Arm Type
Experimental
Arm Description
Participants in the increased eating frequency condition will be instructed to eat > 100 kcals every 2-3 hours.
Intervention Type
Behavioral
Intervention Name(s)
Eating Frequency
Intervention Description
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).
Primary Outcome Measure Information:
Title
Diet
Description
Diet (eating frequency, kilocalories, macronutrients)
Time Frame
0 and 8 weeks
Secondary Outcome Measure Information:
Title
Ecological Momentary Assessment (EMA)
Description
To evaluate the behavioral mechanisms of eating frequency, PalmPilot-based EMA will be used to collect real-time information on consumption cues.
Time Frame
0 and 8 weeks
Title
Anthropometrics
Description
Height (0 weeks only), weight and body mass index
Time Frame
0 and 8 weeks
Title
Binge Eating
Description
Assessed by the Eating Disorder Examination-Questionnaire (EDE-Q), which is a 36-item questionnaire derived from the Eating Disorders Examination interview.
Time Frame
0 and 8 weeks
Title
Physical Activity
Description
Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.
Time Frame
0 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor, PhD, RD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthy Eating and Activity Laboratory, University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

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Healthy Eating Patterns During a Lifestyle Intervention

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