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Trial record 3 of 4 for:    17035649 [PUBMED-IDS]

Eat Well for Life: A Weight Loss Maintenance Study

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ClinicalTrials.gov Identifier: NCT01849627
Recruitment Status : Active, not recruiting
First Posted : May 8, 2013
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hollie Raynor, The University of Tennessee, Knoxville

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Low-ED Behavioral: Energy Balance Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eat Well for Life: A Weight Loss Maintenance Study
Actual Study Start Date : August 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Experimental: 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.
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).




Primary Outcome Measures :
  1. Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months [ Time Frame: 0, 4, 10, 16, and 22 months ]
    Height, weight, and BMI will be assessed.

  2. Changes in diet from baseline at 4, 10, 16, and 22 months [ Time Frame: 0, 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 :
  1. Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months [ Time Frame: 0, 4, 10, 16, and 22 months ]
    Changes in EMA measures on hunger, satiation, and satiety will be assessed.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849627


Locations
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United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
The University of Tennessee, Knoxville
Investigators
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Principal Investigator: Hollie A Raynor, PhD, RD, LDN University of Tennessee

Publications:
Wing RR. Behavioral approaches to the treatment of obesity. In: Bray GA, Bouchard C, James WPT, eds. Handbook of Obesity. New York: Marcel Dekker, Inc.; 1998:855-873
Rolls BJ. The Volumetrics Eating Plan. New York: HarperCollins Publisher; 2005.
Borushek A. The CalorieKing. Cost Mesa: Family Health Publications; 2010.
Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
Barnard ND, Scialli AR, Bertron P, Hurlock D, Edmonds K. Acceptability of a therapeutic low-fat, vegan diet in premenopausal women. Journal of Nutrition Education 2000;32:314-319.
Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York: Wiley & Sons; 1987.
American College of Sports Medicine. ACSM's guidelines for exercise testing and prescription. Vol 5. Philadelphia: Williams and Wilkins; 1995.

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Responsible Party: Hollie Raynor, Professor, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT01849627     History of Changes
Other Study ID Numbers: 9141B
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Hollie Raynor, The University of Tennessee, Knoxville:
weight loss maintenance

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms