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Completed

NCT Number: NCT00944099

Lifestyle, Eating, and Activity Patterns

The purpose of this research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention.

Completed

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthy Eating and Acitivty Laboratory, University of Tennessee

Knoxville, Tennessee, 37996-1920, United States

About this study

Previous observational and experimental research suggests that increased eating frequency is related to lower weight, body mass index (BMI)and body fatness. It is proposed that eating frequently during the day reduces overall energy consumed by preventing the development of excessive hunger. As elevated hunger increases the reinforcing value of food, and greater intake occurs when the reinforcing value of food increases, eating frequently during the day may be a dietary strategy that can aid with reducing energy intake and improving weight loss during a behavioral weight control program. Therefore, the purpose of this proposed research is to test the effect of manipulating eating frequency on hunger and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month behavioral weight loss intervention. Participants will be randomized to 1 of 2 conditions: 1) a condition in which participants will be given an eating frequency prescription to eat every 2 to 3 hours (Grazing); or 2) a condition in which participants will be given an eating frequency prescription of eating 3 meals per day (Three Meals). Both conditions will receive an identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week. Additionally, both conditions will receive an identical state-of-the-art, 6-month, behavioral weight loss program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index (BMI) between 27 and 45 kg/m2

Exclusion criteria

  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
  • report being unable to walk 1/4 mile without stopping
  • report major psychological disease or organic brain syndromes
  • report a diagnosis of type I or type II diabetes
  • are currently participating in a weight loss program, are taking weight loss medication, have had surgery for weight loss, or have lost > 5% of their body weight in the past 6 months
  • are currently participating in a program that manipulates their eating habits
  • intent to move outside of the East Tennessee area within the time frame of the intervention
  • are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the intervention
  • are unwilling to attend group intervention meetings, assessments, or complete a food diary for the duration of the study

Treatment and study plan

Behavioral weight loss intervention

Behavioral

both conditions will receive an identical dietary prescription, low-calorie and less than 30% calories from fat and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week during a 6 month behavioral weight loss program

Primary outcomes

  1. eating occasions per day

    Time frame: 0, 3, and 6 months

  2. hunger and reinforcing value of food

    Time frame: 0, 3, and 6 months

Secondary outcomes

  1. energy and percent calories from fat intake

    Time frame: 0, 3, and 6 months

  2. body weight, percent body fat, percent fat free mass

    Time frame: 0, 3, and 6 months

Sponsors and collaborators

Lead sponsor

The University of Tennessee, Knoxville

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Eating Frequency Prescription for a Behavioral Weigh Loss Intervention

Acronym: LEAP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2009
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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