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Med-South Diet vs. WW for Weight Loss (DELISH Trial)
N/A
Waitlist Available
Led By Carmen D Samuel-Hodge, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-75 (inclusive)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 4, 12, and 24
Awards & highlights
DELISH Trial Summary
This trial will compare a new weight-loss program, developed to be more acceptable and realistic for southerners, with WW™ (formally Weight Watchers). Those who take part will be randomly assigned to one of the two programs. The primary outcome measured by the trial will be weight loss at 24 months, but researchers will also collect data which may show additional health benefits of the Med-South diet.
Who is the study for?
This trial is for adults aged 18-75 with a BMI of 30 or higher who have control over their diet, speak English, and are established patients at participating practices. They must not be considering bariatric surgery, pregnant, or have certain medical conditions like advanced kidney disease or type 1 diabetes.Check my eligibility
What is being tested?
The study compares the Med-South weight loss program—an adapted Mediterranean diet suitable for southerners—to WW™ (formerly Weight Watchers). Participants will follow their assigned programs for two years with check-ups every few months to track weight loss and health changes like inflammation levels and fruit/vegetable intake.See study design
What are the potential side effects?
While specific side effects aren't listed as it's a dietary intervention study rather than medication-based, potential side effects may include initial hunger or discomfort adjusting to new eating habits, nutritional deficiencies if not balanced properly, and possible gastrointestinal changes.
DELISH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
DELISH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 4, 12, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 4, 12, and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Weight Change from Baseline to Month 24
Secondary outcome measures
Economic Outcome--Incremental Cost per Quality Adjusted Life Year (QALY) gained
Economic Outcome--Incremental Cost-Effectiveness
Mean Change LDL-cholesterol from Baseline through Follow-up
+21 moreDELISH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Med-South Weight Loss InterventionExperimental Treatment1 Intervention
The intervention will be delivered in 3 phases over 24 months: Phase I (4 months) provides a foundation for adopting and maintaining a healthful dietary pattern (Med-style, tailored for the southeastern United States); Phase II (8 months) focuses on weight loss; and Phase III (12 months) on maintenance of or continued weight loss, as appropriate.
Group II: Augmented Usual Care (WW)Active Control1 Intervention
The intervention that will be offered to control group participants is WW™ (formerly known as Weight Watchers). The study will provide access to the 'Workshop + Digital' option of WW™ during the 2 year intervention.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,302 Total Patients Enrolled
22 Trials studying Weight Loss
4,458 Patients Enrolled for Weight Loss
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,136 Total Patients Enrolled
37 Trials studying Weight Loss
7,401 Patients Enrolled for Weight Loss
Carmen D Samuel-Hodge, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.My kidney function is severely reduced.I am between 18 and 75 years old.I am considering or have had bariatric surgery.I have had cancer other than non-melanoma skin cancer, but it was cured or has been in remission for over 5 years.I have been part of a weight loss program with over 6 visits last year.I have a known heart condition but can still participate.
Research Study Groups:
This trial has the following groups:- Group 1: Med-South Weight Loss Intervention
- Group 2: Augmented Usual Care (WW)
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.
Weight Loss Patient Testimony for trial: Trial Name: NCT04302727 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation need more participants at present?
"According to the information listed on clinicaltrials.gov, this particular medical trial is no longer accepting new patients as of August 4th 2022 - though 364 other trials are currently looking for participants. The initial posting was made on July 6th 2020."
Answered by AI
Does this research endeavor include participants aged 20 and above?
"This research is recruiting subjects aged 18 or above and 75 or below."
Answered by AI
Which persons are appropriate to participate in this research?
"This clinical trial is recruiting 360 individuals over the age of 18 and under 75 who are struggling with obesity. To be eligible, they must have a BMI of at least 30 kg/m^2; not plan to move in the next year; possess control over dietary decisions; possibly suffer from cardiovascular disease; and own or access a telephone."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
UNC Center for Health Promotion and Disease Prevention
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
To help control my type 2 - Diabetis and to lose weight! My Dr. said I need to lose weight. I was up to 190 during the pandemic and I’ve gotten down to 180, but seem to be at a standstill. I saw this trial and thought it may help.
PatientReceived 1 prior treatment
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