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Healthy Eating Patterns During a Lifestyle Intervention (HEP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682317
First Posted: September 10, 2012
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hollie Raynor, University of Tennessee
  Purpose
The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

Condition Intervention
Obesity Weight Loss Behavioral: Eating Frequency

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healthy Eating Patterns During a Lifestyle Intervention

Resource links provided by NLM:


Further study details as provided by Hollie Raynor, University of Tennessee:

Primary Outcome Measures:
  • Diet [ Time Frame: 0 and 8 weeks ]
    Diet (eating frequency, kilocalories, macronutrients)


Secondary Outcome Measures:
  • 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.

  • Anthropometrics [ Time Frame: 0 and 8 weeks ]
    Height (0 weeks only), weight and body mass index

  • 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.

  • Physical Activity [ Time Frame: 0 and 8 weeks ]
    Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.


Estimated Enrollment: 30
Actual Study Start Date: August 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682317


Locations
United States, Tennessee
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Hollie A Raynor, PhD, RD University of Tennessee
  More Information

Responsible Party: Hollie Raynor, Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT01682317     History of Changes
Other Study ID Numbers: UTK IRB# FWA 6629
First Submitted: September 5, 2012
First Posted: September 10, 2012
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Hollie Raynor, University of Tennessee:
eating frequency

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms