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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
345
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 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).
University of Tennessee
Knoxville, Tennessee, United States
Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months
Height, weight, and BMI will be assessed.
Time frame: 0, 4, 10, 16, and 22 months
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.
Time frame: 0, 4, 10, 16, and 22 months
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.
Time frame: 0, 4, 10, 16, and 22 months
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