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

N/A

Waitlist Available

Led By Hollie A Raynor, PhD, RD, LDN

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 70 years

Be older than 18 years old

Must not have

Report major psychiatric diseases or organic brain syndromes

Had bariatric surgery for weight loss or planning to have bariatric surgery in the next 22 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 4, 10, 16, and 22 months

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates whether a low-ED diet helps people keep weight off better than an energy balance diet.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since this is a dietary intervention, side effects may include changes in digestion, potential nutrient deficiencies if not properly managed, and possible initial hunger or dissatisfaction as participants adjust to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant psychiatric condition or brain disorder.

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I have had or plan to have weight loss surgery within 22 months.

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I have heart issues, chest pain during activity or rest, or have fainted.

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I have lost 8% or more of my initial weight after 4 months of trying.

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I can't walk 2 blocks without stopping.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 4, 10, 16, and 22 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 4, 10, 16, and 22 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 4, 10, 16, and 22 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months

Changes in diet from baseline at 4, 10, 16, and 22 months

Secondary study objectives

Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Energy Balance

2018

N/A

~60

0 / 6Eligibility criteria met