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Digital Weight Loss Intervention for Cardiovascular Risk in Obesity (RESILIENCE Trial)

N/A
Waitlist Available
Led By Neha Pagidipati, MD, MPH
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 40-75 years old
Fall into 1 of 4 categories: 200 participants with obesity (BMI ≥ 30) and high 10-year ASCVD risk (≥20%), 200 participants with obesity (BMI ≥ 30) and low 10-year ASCVD risk (<7.5%), 100 participants with normal weight (BMI 18-25) and high 10-year ASCVD risk (≥20%), and 100 participants with normal weight (BMI 18-25) and low 10-year ASCVD risk (<7.5%).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, up to 2 years
Awards & highlights

RESILIENCE Trial Summary

This trialaims to understand why some people with obesity are more resistant to cardiovascular disease than others.

Who is the study for?
The RESILIENCE trial is for adults aged 40-75 who are either overweight (BMI ≥ 30) or of normal weight (BMI 18-25), with varying risks for heart disease but no history of it. Participants must have internet access, a smartphone, an email listed in Duke's EHR, and at least one BMI record from the past year. Pregnant women, those recently post-partum, individuals with prior bariatric surgery or who've opted out of research contact are excluded.Check my eligibility
What is being tested?
This study tests a digital weight loss program to understand why some overweight people don't develop heart disease while others do. It involves participants with different body weights and cardiovascular risk levels to see how they respond differently to the intervention.See study design
What are the potential side effects?
Since this is a digital weight loss intervention rather than medication or invasive treatment, typical medical side effects aren't expected. However, participants may experience lifestyle changes due to diet adjustments and increased physical activity.

RESILIENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 75 years old.
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I am either overweight or of normal weight and have a specific 10-year heart disease risk level.
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I have never had heart disease, stroke, or surgery for blood vessel problems.

RESILIENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average branched-chain amino acid levels as measured by metabolomics analyses
Change in branched-chain amino acid levels as measured by metabolomics analyses
Other outcome measures
Blood Glucose
Average blood glucose control as measured by blood insulin level
Average blood glucose control as measured by fasting glucose
+23 more

RESILIENCE Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Obese Low RiskExperimental Treatment1 Intervention
200 participants with BMI ≥30 and 10-year ASCVD risk <7.5%
Group II: Obese High RiskExperimental Treatment1 Intervention
200 participants with BMI ≥30 and 10-year ASCVD risk ≥20%
Group III: Non-Obese High RiskActive Control1 Intervention
100 participants with BMI 18-25 and 10-year ASCVD risk ≥20%
Group IV: Non-Obese Low RiskActive Control1 Intervention
100 participants with BMI 18-25 and 10-year ASCVD risk <7.5%

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,471 Total Patients Enrolled
2 Trials studying Cardiovascular Risk
507 Patients Enrolled for Cardiovascular Risk
Neha Pagidipati, MD, MPHPrincipal InvestigatorDuke University

Media Library

Digital weight loss intervention Clinical Trial Eligibility Overview. Trial Name: NCT04551872 — N/A
Cardiovascular Risk Research Study Groups: Obese Low Risk, Non-Obese High Risk, Non-Obese Low Risk, Obese High Risk
Cardiovascular Risk Clinical Trial 2023: Digital weight loss intervention Highlights & Side Effects. Trial Name: NCT04551872 — N/A
Digital weight loss intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551872 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I submit my name for consideration in this research project?

"Candidates who are obese and between the ages of 40 and 75 can apply for this medical trial, which aims to enrol 600 people."

Answered by AI

Is enrollment for this investigation currently open to participants?

"Unfortunately, the data posted on clinicaltrials.gov reveals that this trial is not presently accepting new patients; it was initially listed on September 22nd 2020 and last updated October 11th 2022. Despite this closure, 1028 other trials are actively recruiting for participants at present."

Answered by AI

Does the eligibility for this clinical trial extend to elderly individuals?

"This clinical trial has an age requirement of 40-75, with 203 studies available for people below 18 and 656 trials applicable to those over 65."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
65+
What site did they apply to?
Duke University Health System
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
RESILIENCE: Personalizing Cardiovascular Health
2020. "RESILIENCE: Personalizing Cardiovascular Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04551872.
~133 spots leftby Apr 2025
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