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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 : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hollie Raynor, The University of Tennessee, Knoxville

Tracking Information
First Submitted Date  ICMJE April 30, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Change in Anthropometrics from Baseline at 3 and 6 months [ Time Frame: 0, 3, and 6 months ]
Height, weight, and BMI will be assessed.
Change History Complete list of historical versions of study NCT01849627 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Change in Diet from Baseline at 3 and 6 months [ Time Frame: 0, 3, and 6 months ]
Three day food records will be used to assess energy, grams, energy density, macronutrients, fiber, and food group servings.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eat Well for Life: A Weight Loss Maintenance Study
Official Title  ICMJE Eat Well for Life: A Weight Loss Maintenance Study
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Low-ED
  • 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.
    Intervention: Behavioral: Energy Balance
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2014)
345
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
38
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849627
Other Study ID Numbers  ICMJE 9141B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hollie Raynor, The University of Tennessee, Knoxville
Study Sponsor  ICMJE The University of Tennessee, Knoxville
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hollie A Raynor, PhD, RD, LDN University of Tennessee
PRS Account The University of Tennessee, Knoxville
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP