Eat Well for Life: A Weight Loss Maintenance Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | August 2014 |
| End Date: | July 2020 |
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.
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.
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.
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.
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