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Eat Well for Life: A Weight Loss Maintenance Study

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-ED
Energy Balance
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 weight loss maintenance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18 and 70 years
  • 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 on the Physical Activity Readiness Questionnaire
  • Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping
  • Report major psychiatric diseases or organic brain syndromes.
  • Are currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost > 5% of body weight during the past 6 months
  • Have had bariatric surgery for weight loss or are planning to have bariatric surgery in the next 22 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
  • Report not being able to consume meal replacements

To participate in the weight loss maintenance phase, participants will need to lose equal to or greater than 8% of their body weight from the baseline measure at the conclusion of the 4-month weight loss phase.

Sites / Locations

  • University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-ED

Energy Balance

Arm Description

This condition will focus lowering on the energy density of the diet of the diet. This prescription does not include goals for any other nutrients, thus there are no energy goals.

This condition will focus have an energy balance prescription. Participants will be asked to consume a daily energy intake at estimated energy needs for weight loss maintenance.

Outcomes

Primary Outcome Measures

Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months
Height, weight, and BMI will be assessed.
Changes in diet from baseline at 4, 10, 16, and 22 months
Three day food records will be used to assess energy, grams, energy density, macronutrients, fiber, and food group servings.

Secondary Outcome Measures

Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months
Changes in EMA measures on hunger, satiation, and satiety will be assessed.

Full Information

First Posted
April 30, 2013
Last Updated
June 17, 2023
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT01849627
Brief Title
Eat Well for Life: A Weight Loss Maintenance Study
Official Title
Eat Well for Life: A Weight Loss Maintenance Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2014 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
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
A study to investigate the effect of a low-ED prescription (consume ≥10 foods ≤ 1.0 kcal/g and ≤ 2 foods ≥ 3.0 kcal/g per day) versus an energy balance prescription (consume a daily energy intake at estimated energy needs for maintenance) on weight loss maintenance.
Detailed Description
Obesity increases the risk of several health conditions. Weight loss of 5-10% of initial weight reduces the risk of several diseases. This degree of weight loss is achievable in behavioral obesity programs. However, about 33% of initial weight loss is regained within one year and very little weight loss is maintained within three to five years. Thus, new strategies improving long-term weight loss maintenance are needed. One dietary strategy that increases self-reported satiation and satiety is consuming a low energy density (ED) diet. A low-ED diet allows a greater weight of food relative to total energy to be consumed, which is the proposed mechanism for the enhanced self-reported satiation and satiety found with low-ED meals. Research has shown that when participants are served low-ED meals, while total weight of food consumed does not change, meal energy intake decreases. Importantly, when low-ED meals are consumed across several days, reduced energy intake continues to occur, showing no degree of energy intake compensation. To address the gaps regarding the relationship between dietary ED and weight loss maintenance, we propose to conduct a randomized controlled trial (RCT) examining the effect of a low-ED prescription and its proposed mechanisms on weight loss maintenance. The primary hypotheses are: Low-ED will have less weight regain than Energy Balance at 22 months. a. Weight regain at 10, 16, and 22 months will be examined to determine if differences occur between conditions. Low-ED will consume a lower ED diet, less energy and percent energy from fat, and greater grams from solid food and fiber than Energy Balance at 10, 16, and 22 months. The secondary hypotheses are: Identify mechanisms (mediators) by which reducing ED improves long-term lower energy intake, thus: Low-ED will self-report lower hunger and greater satiation and satiety during EMA than Energy Balance at 10, 16, and 22 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss maintenance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Low-ED
Arm Type
Experimental
Arm Description
This condition will focus lowering on the energy density of the diet of the diet. This prescription does not include goals for any other nutrients, thus there are no energy goals.
Arm Title
Energy Balance
Arm Type
Experimental
Arm Description
This condition will focus have an energy balance prescription. Participants will be asked to consume a daily energy intake at estimated energy needs for weight loss maintenance.
Intervention Type
Behavioral
Intervention Name(s)
Low-ED
Intervention Description
This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day.
Intervention Type
Behavioral
Intervention Name(s)
Energy Balance
Intervention Description
Energy Balance will receive an individualized daily energy goal which will be their measured resting metabolic rate multiplied by a physical activity level (PAL) of 1.12 (men) or 1.14 (women) (low active).
Primary Outcome Measure Information:
Title
Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months
Description
Height, weight, and BMI will be assessed.
Time Frame
0, 4, 10, 16, and 22 months
Title
Changes in diet from baseline at 4, 10, 16, and 22 months
Description
Three day food records will be used to assess energy, grams, energy density, macronutrients, fiber, and food group servings.
Time Frame
0, 4, 10, 16, and 22 months
Secondary Outcome Measure Information:
Title
Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months
Description
Changes in EMA measures on hunger, satiation, and satiety will be assessed.
Time Frame
0, 4, 10, 16, and 22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18 and 70 years 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 on the Physical Activity Readiness Questionnaire Individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate Report being unable to walk for 2 blocks (1/4 mile) without stopping Report major psychiatric diseases or organic brain syndromes. Are currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost > 5% of body weight during the past 6 months Have had bariatric surgery for weight loss or are planning to have bariatric surgery in the next 22 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 Report not being able to consume meal replacements To participate in the weight loss maintenance phase, participants will need to lose equal to or greater than 8% of their body weight from the baseline measure at the conclusion of the 4-month weight loss phase.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor, PhD, RD, LDN
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

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Eat Well for Life: A Weight Loss Maintenance Study

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