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

345 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+