RESILIENCE: Personalizing Cardiovascular Health

Sponsor

Duke University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04551872

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Obesity is a rapidly growing epidemic that is associated with the development of cardiovascular disease (CVD). However, some individuals with obesity appear to be resistant to CVD, and other individuals demonstrate resilience to obesity and CVD risk factors. The investigator's overall objective is to understand factors contributing to the heterogeneity of CVD resistance and resilience among individuals with obesity at Duke.

Condition or Disease	Intervention/Treatment	Phase
Obesity Cardiovascular Risk Factor	Behavioral: Digital weight loss intervention	N/A

Detailed Description

The investigator aims to recruit participants with 4 phenotypes: 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%). Clinical, behavioral, and molecular characteristics will be compared at baseline between the 4 groups to understand heterogeneity between obesity and risk for CVD, and participants with obesity will undergo a 6-month weight loss intervention. In individuals with obesity, clinical, behavioral, and molecular characteristics will be compared between baseline and 6 months to understand (a) predictors of response to the intervention and (b) how these factors change with weight loss. Differences in branched-chain amino acids will be compared between all groups, both at baseline and at 6 months (for those participants undergoing the digital-weight loss intervention). Other clinical, behavioral, metabolomic, genetic, and microbiome parameters will also be compared in an exploratory fashion. There may be possible risk of loss of confidentiality, but this risk is low and measures will be taken to minimize this risk.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Personalizing Cardiovascular Health: A Population Approach to Promoting CVD Resistance and Resilience Among Individuals With Obesity

Actual Study Start Date :

Sep 22, 2020

Anticipated Primary Completion Date :

Sep 22, 2022

Anticipated Study Completion Date :

Sep 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Obese High Risk 200 participants with BMI ≥30 and 10-year ASCVD risk ≥20%	Behavioral: Digital weight loss intervention Participants with obesity enter into a proven 6 month weight loss program that utilizes health coaching and goal-setting. It is a remote intervention that is delivered entirely over their phones. Participants will also receive a FitBit and electronic scale.
Experimental: Obese Low Risk 200 participants with BMI ≥30 and 10-year ASCVD risk <7.5%	Behavioral: Digital weight loss intervention Participants with obesity enter into a proven 6 month weight loss program that utilizes health coaching and goal-setting. It is a remote intervention that is delivered entirely over their phones. Participants will also receive a FitBit and electronic scale.
No Intervention: Non-Obese High Risk 100 participants with BMI 18-25 and 10-year ASCVD risk ≥20%
No Intervention: Non-Obese Low Risk 100 participants with BMI 18-25 and 10-year ASCVD risk <7.5%

Outcome Measures

Primary Outcome Measures

Average branched-chain amino acid levels as measured by metabolomics analyses [Baseline]
Change in branched-chain amino acid levels as measured by metabolomics analyses [Baseline, End of intervention (up to 6 months)]

Other Outcome Measures

Gut microbiome composition as measured by DNA sequencing [Baseline]
Change in gut microbiome composition as measured by DNA sequencing [Baseline, End of intervention (up to 6 months)]
Genetic markers as measured by whole exome sequencing of DNA from saliva [Baseline]
Impact of branched-chain amino acids on tissue engineered blood vessel function as measured by monocyte adhesion [Baseline]
Impact of branched-chain amino acids on tissue engineered blood vessel function as measured by foam cell formation [Baseline]
Change in impact of branched-chain amino acids on tissue engineered blood vessel function as measured by monocyte adhesion [Baseline, End of intervention (up to 6 months)]
Change in impact of branched-chain amino acids on tissue engineered blood vessel function as measured by foam cell formation [Baseline, End of intervention (up to 6 months)]
Average levels of inflammation measured by hs-CRP [Baseline]
Change in average levels of inflammation measured by by hs-CRP [Baseline, End of intervention (up to 6 months)]
Average lipid profile as measured by total cholesterol [Baseline]
Change in lipid profile as measured by total cholesterol [Baseline, End of intervention (up to 6 months)]
Average lipid profile as measured by HDL [Baseline]
Change in lipid profile as measured by HDL [Baseline, End of intervention (up to 6 months)]
Average lipid profile as measured by LDL [Baseline]
Change in lipid profile as measured by LDL [Baseline, End of intervention (up to 6 months)]
Average blood glucose control as measured by HbA1c [Baseline]
Change in blood glucose control as measured by HbA1c [Baseline, End of intervention (up to 6 months)]
Average blood glucose control as measured by fasting glucose [Baseline]
Change in blood glucose control as measured by fasting glucose [Baseline, End of intervention (up to 6 months)]
Average blood glucose control as measured by blood insulin level [Baseline]
Change in blood glucose control as measured by blood insulin level [Baseline, End of intervention (up to 6 months)]
Average coronary artery calcium score as measured by CT testing [Baseline]
Change in coronary artery calcium score as measured by CT testing [Baseline, End of intervention (up to 6 months)]
Engagement as measured by percent of invitees viewing study-information page [End of study, up to 2 years]
Best consent strategy as measured by percent of invitees signing the consent form [End of study, up to 2 years]
Best consent strategy as measured by average score on Informed Consent Form comprehension quiz [End of study, up to 2 years]
7 multiple choice questions, best outcome is 7/7 (100%), worst outcome is 0/7 (0%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults 40-75 years old
At least one clinic encounter at Duke with BMI record in the EHR within previous year
Has a current primary care provider listed listed in EHR
No prior history of ASCVD, as defined by ICD9, ICD10, and CPT codes for coronary artery disease, myocardial infarction, stroke, peripheral arterial disease, prior revascularization for coronary, cerebral, or peripheral arteries.
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%).
Have internet access
Have an email address listed in the EHR
Have access to MyChart
Have a smartphone
Be able to read and understand English