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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 4, 10, 16, and 22 months
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
I am between 18 and 70 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
83 Previous Clinical Trials
18,214 Total Patients Enrolled
17 Trials studying Obesity
6,939 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant psychiatric condition or brain disorder.I am in a weight loss program or taking medication for it, or I've lost more than 5% of my body weight in the last 6 months.I have had or plan to have weight loss surgery within 22 months.I have heart issues, chest pain during activity or rest, or have fainted.I have joint problems or other conditions that may limit exercise but have a doctor's consent to participate.I have lost 8% or more of my initial weight after 4 months of trying.I am between 18 and 70 years old.I can't walk 2 blocks without stopping.
Research Study Groups:
This trial has the following groups:- Group 1: Low-ED
- Group 2: Energy Balance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research experiment currently recruiting participants?
"Clinicaltrials.gov indicates that this trial, initially posted in August 2014 and last updated on March 15th 2022, is not currently recruiting patients for participation. Despite its closure for enrollment, 1067 other medical studies are actively searching for participants at the present time."
Answered by AI
What characteristics should potential participants of this experiment possess?
"The eligibility criteria for this research outlines that candidates must have obesity and be within the age range of 18 to 70. Consequently, a total of 345 individuals need to partake in this experiment."
Answered by AI
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