Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
345 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-08-31
Study Completion Date
2025-12-31
Brief Summary
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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.
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Detailed Description
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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:
1. 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.
2. 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:
3. Identify mechanisms (mediators) by which reducing ED improves long-term lower energy intake, thus:
1. Low-ED will self-report lower hunger and greater satiation and satiety during EMA than Energy Balance at 10, 16, and 22 months.
The primary hypotheses are:
1. 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.
2. 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:
3. Identify mechanisms (mediators) by which reducing ED improves long-term lower energy intake, thus:
1. Low-ED will self-report lower hunger and greater satiation and satiety during EMA than Energy Balance at 10, 16, and 22 months.
Conditions
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Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Low-ED
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.
Group Type
EXPERIMENTAL
Low-ED
Intervention Type
BEHAVIORAL
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.
Energy Balance
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.
Group Type
EXPERIMENTAL
Energy Balance
Intervention Type
BEHAVIORAL
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).
Interventions
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Low-ED
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
Energy Balance
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).
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 70 years
* Body mass index (BMI) between 27 and 45 kg/m2
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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The University of Tennessee, Knoxville
OTHER
Sponsor Role
lead
Responsible Party
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Hollie Raynor
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Hollie A Raynor, PhD, RD, LDN
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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University of Tennessee
Knoxville, Tennessee, United States
Site Status
Countries
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United States
References
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Other Identifiers
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9141B
Identifier Type: -
Identifier Source: org_study_id
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