345 Participants Needed

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

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

Trial Summary

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.

Research Team

HA

Hollie A Raynor, PhD, RD, LDN

Principal Investigator

University of Tennessee

Eligibility Criteria

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.
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Timeline

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

Treatment Details

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).
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Low-EDExperimental Treatment1 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 BalanceExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Tennessee, Knoxville

Lead Sponsor

Trials
93
Recruited
19,500+
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