The Healthy Eating Choices for Life Program (HEC4L)

April 3, 2018 updated by: Hollie Raynor, The University of Tennessee, Knoxville

The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.

The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Given the current prevalence of overweight and obesity among adults in the United States and the projected increase of these conditions in the future, development of effective weight loss and weight loss maintenance strategies is imperative. For weight loss to occur, energy intake needs to be reduced to incur an energy deficit, and for successful weight loss maintenance, energy intake needs to remain lower than energy intake at pre-weight loss levels due to an overall reduction in body size which reduces basal metabolic rate. One dietary strategy that may facilitate weight loss maintenance is consuming a diet low in dietary energy density (ED). This pilot study will test the effects of a dietary prescription focused on ED.

All participants in the investigation will receive a standard 12-week behavioral obesity intervention. The intervention will include an activity goal that participants will gradually work to achieve over the course of the 12-week intervention along with standard behavioral weight loss strategies. One condition will receive a dietary prescription for weight loss that focuses solely on lowering the ED of the diet, another condition will receive the traditional dietary prescription used in behavioral weight loss interventions that reduces energy intake, and the third condition will receive both prescriptions. Pre and post intervention measurements will be taken to determine if there are differences between groups.

Study Type

Interventional

Enrollment (Actual)

45

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

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37996-1920
        • Healthy Eating and Activity Laboratory

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 21 and 65 years
  • Body mass index (BMI) between 25 and 45 kg/m2

Exclusion Criteria:

  • Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping
  • Report major psychiatric diseases/organic brain syndromes via a phone screen
  • 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
  • Intend to move to another city within the time frame of the investigation
  • Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation
  • Have had gastric surgery for weight loss

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: Energy Density
Behavioral: Standard Behavioral Weight Loss Intervention
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake
Consume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day.
Active Comparator: Lifestyle Treatment
Behavioral: Standard Behavioral Weight Loss Intervention
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Behavioral: Dietary Goal: Reduction of Energy Intake
Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.
Experimental: Energy Density + Lifestyle Treatment
Behavioral: Standard Behavioral Weight Loss Intervention
12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake
Consume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day.
Behavioral: Dietary Goal: Reduction of Energy Intake
Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy density of the diet
Time Frame: Weeks 0 and 13
Energy density is defined as the kilocalories per gram of a food. Energy density will be measured by collecting and analyzing 3-day food records using Nutrition Data Systems for Research at baseline (week 0) and post intervention (week 13).
Weeks 0 and 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: Weeks 0 and 13
Weeks 0 and 13
Feelings of dietary deprivation and satisfaction
Time Frame: Weeks 0 and 13
Dietary deprivation and satisfaction will be measures using 100mm visual analog scales with the statements "I feel like I ate enough today" and "I feel like I ate what I wanted today". Both scales are anchored with "strongly disagree" on one end and "strongly agree" on the other end. These will be collected for 7 days at baseline (week 0) and post intervention (week 13).
Weeks 0 and 13
Hunger
Time Frame: Weeks 0 and 13
Hunger will be measured using a 100mm visual analog scale. The scale asks "How hungry did you feel today?" and is anchored with "not at all hungry" on one end and "extremely hungry" on the other. Hunger scales will be collected for 7 days at baseline (week 0) and post intervention (week 13).
Weeks 0 and 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Investigators

  • Principal Investigator: Hollie A Raynor, PhD, RD, LDN, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

January 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 8107 B

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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