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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

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 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

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

Find a Location

Who is running the clinical trial?

The University of Tennessee, KnoxvilleLead Sponsor
85 Previous Clinical Trials
18,397 Total Patients Enrolled
18 Trials studying Obesity
7,092 Patients Enrolled for Obesity
Hollie A Raynor, PhD, RD, LDNPrincipal InvestigatorUniversity of Tennessee
4 Previous Clinical Trials
149 Total Patients Enrolled
2 Trials studying Obesity
73 Patients Enrolled for Obesity

Media Library

Energy Balance Clinical Trial Eligibility Overview. Trial Name: NCT01849627 — N/A
Obesity Research Study Groups: Low-ED, Energy Balance
Obesity Clinical Trial 2023: Energy Balance Highlights & Side Effects. Trial Name: NCT01849627 — N/A
Energy Balance 2023 Treatment Timeline for Medical Study. Trial Name: NCT01849627 — N/A
~8 spots leftby Dec 2024
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