Eat Well for Life: A Weight Loss Maintenance Study

Study Overview
=================
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: 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.

Official Title
-----------------
Eat Well for Life: A Weight Loss Maintenance Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Low-ED
* Behavioral: Energy Balance


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-ED<br>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<br>* 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.<br>|
| Experimental: Energy Balance<br>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<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months | Height, weight, and BMI will be assessed. | 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. | 0, 4, 10, 16, and 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 4, 10, 16, and 22 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss maintenance