Low-ED Diet vs Energy Balance Diet for Weight Loss Maintenance

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Tennessee, Knoxville

Must not be taking: Weight loss drugs

Disqualifiers: Heart condition, Joint problems, Psychiatric diseases, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 22 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which eating plan better maintains weight loss. One group will consume foods low in energy density, focusing on items with fewer calories per gram (Low-ED diet). The other group will follow a diet tailored to their energy needs to maintain weight loss (Energy Balance diet). Individuals with a BMI between 27 and 45 who have recently lost at least 8% of their body weight may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to valuable research on effective weight maintenance strategies.

Will I have to stop taking my current medications?

The trial does not clearly state if you need to stop taking your current medications. However, if you are on prescription medications that could limit exercise, you will need written consent from your doctor to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that diets with low energy density (Low-ED) can be safe and effective for maintaining weight loss. One study found that people on a Low-ED diet tend to maintain their weight loss longer and have a lower risk of heart disease. Another study tested a similar diet on teenagers and found it safe and easy to follow.

For the energy balance diet, research indicates it helps manage weight by matching calorie intake with calorie expenditure. This approach is generally easy to follow and is often used as a long-term strategy for maintaining weight.

Both diets focus on controlling energy intake, which is important for sustaining weight loss. Available evidence suggests both diets are safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for weight loss maintenance because they explore dietary approaches beyond the typical calorie-counting methods. The Low-ED (low energy density) diet focuses on reducing the overall energy density of meals, allowing people to consume satisfying portions without strict calorie limits. Meanwhile, the Energy Balance approach tailors daily energy intake to individual needs, encouraging sustainable weight management by aligning intake with the body's energy requirements. These strategies aim to offer more flexible and personalized options compared to traditional diets, potentially improving long-term adherence and success in maintaining weight loss.

What evidence suggests that this trial's treatments could be effective for weight loss maintenance?

This trial will compare a low-energy-dense (Low-ED) diet with an energy balance diet for weight loss maintenance. Previous studies have shown that a Low-ED diet, which includes foods low in calories per gram, can help people maintain weight loss. Research indicates that this diet can control appetite and support lasting weight loss. In contrast, an energy balance diet, which focuses on consuming the same amount of calories burned to maintain stable weight, has shown mixed results. Some evidence suggests that very-low-energy diets outperform balanced diets for long-term weight maintenance. However, many individuals on balanced diets tend to regain lost weight over time. Both approaches have strengths, but results can vary from person to person. ^{2 6 7 8 9}

Who Is on the Research Team?

Hollie A Raynor, PhD, RD, LDN

Principal Investigator

University of Tennessee

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 70 with a BMI between 27 and 45, indicating overweight or obesity. It's designed for those who are interested in maintaining weight loss through specific dietary strategies.

Inclusion Criteria

Body mass index (BMI) between 27 and 45 kg/m2

Exclusion Criteria

Intend to move outside of the metropolitan area within the time frame of the investigation

Pregnant, lactating, < 6 months post-partum, or plan to become pregnant during the investigation

I have a significant psychiatric condition or brain disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a low energy density diet or an energy balance diet to maintain weight loss

22 months

Regular assessments at 4, 10, 16, and 22 months

Follow-up

Participants are monitored for weight maintenance and dietary adherence

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Energy Balance
• Low-ED

Trial Overview The study compares two diet-based approaches to keep weight off: one group will eat foods low in energy density (low-ED), while the other will balance daily calorie intake with their estimated needs for maintenance (energy balance).

How Is the Trial Designed?

Group I: Low-ED Experimental Treatment 1 Intervention

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.

Group II: Energy Balance Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials

93

Recruited

19,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8017325/

Optimal Diet Strategies for Weight Loss and ... - PubMed Central An energy deficit is the most important factor in weight loss. A low-calorie diet with a low fat or carbohydrate content has been recommended; however, in some ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523063748

Long-term weight-loss maintenance: a meta-analysis of US ... Successful very-low-energy diets (VLEDs) were associated with significantly greater weight-loss maintenance than were successful hypoenergetic balanced diets ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5764193/

Maintenance of lost weight and long-term management of ... In a meta-analysis of 29 long-term weight loss studies, more than half of the lost weight was regained within two years, and by five years more than 80% of lost ...

4. nature.com nature.com/articles/s41430-024-01523-8

comparison between bariatric surgery and low-calorie diet After 52 weeks, weight loss was 44.3 ± 16.4 kg and TDEE decreased by 583 ± 418 kcal/d (P < 0.001), compared to 4.3 ± 6.7 kg and 84 ± 285 kcal/d ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499267113001883

The Maintenance of Energy Balance Is Compromised after ... Adults who participated in a very-low-energy-diet program or lost ≥20 kg maintained a weight-loss of 7.0 kg or 29% of initial weight loss (2). Although ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK221839/

Weight-Loss and Maintenance Strategies - NCBI - NIH They found that VLCD participants lost significantly more weight initially and maintained significantly more weight loss than participants on the hypocaloric- ...

7. nesr.usda.gov nesr.usda.gov/energy-balance-and-weight-management-subcommittee

Energy Balance and Weight Management Subcommittee For older adults, the relationships between weight loss and weight maintenance and mortality and disease risk were reviewed. Listed in the next section are the ...

8. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa0804748

Comparison of Weight-Loss Diets with Different ... Other studies showed increased weight loss at 1 to 2 years with diets that were high in unsaturated fat or with low-fat, high-carbohydrate vegetarian diets.