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Healthy Eating Patterns During a Lifestyle Intervention (HEP)

This study is currently recruiting participants.
Verified September 2012 by University of Tennessee
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT01682317
First received: September 5, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healthy Eating Patterns During a Lifestyle Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Diet [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
    Diet (eating frequency, kilocalories, macronutrients)


Secondary Outcome Measures:
  • Ecological Momentary Assessment (EMA) [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Height (0 weeks only), weight and body mass index

  • Binge Eating [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self-reported physical activity will be assessed using the Paffenbarger Activity Questionnaire.


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682317

Contacts
Contact: Hollie Raynor, PhD, RD 865-974-0752 hraynor@utk.edu

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

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT01682317     History of Changes
Other Study ID Numbers: UTK IRB# FWA 6629
Study First Received: September 5, 2012
Last Updated: September 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
eating frequency

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 21, 2013