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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Low-ED Behavioral: Energy Balance||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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 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).
- 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.
- 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.
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
|United States, Tennessee|
|University of Tennessee|
|Knoxville, Tennessee, United States, 37996|
|Principal Investigator:||Hollie A Raynor, PhD, RD, LDN||University of Tennessee|