Cardiovascular Risk Factor, Obesity
Conditions
Keywords
Obesity, Translating Duke Health, RESILIENCE, CVD, DUHS, Duke, Heart Disease
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.
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. Recruitment Sub-Study: We aim to determine optimal strategies to recruit participants into the study via electronic recruitment. We will identify potentially eligible participants within the Duke Electronic Health Record and reach out them via electronic means. Potentially eligible participants will be randomized in a 2x2 factorial fashion to receive personal email vs. MyChart message, and to different message content (1 of 4 types). We will analyze: a) which modality of introductory message delivery (MyChart vs personal email) will lead to greater engagement (as assessed by clicking on the study website page to get more information) b) which messages (altruism vs personal benefit vs scientific importance) will lead to greater engagement. Consent Sub-Study: We aim to determine optimal strategies to consent participants into the study via e-consent portal. Potential participants who land on the study website will be randomized to consent via one of four methods, followed by a consent-comprehension quiz: a) video consent with study information provided by a representative patient, b) video consent with study information provided by the lead physician of the study, c) video consent with study information provided by animation/cartoon or d) text-based study information and consent (standard). We will analyze which type of consent form will lead to greater completion of consent forms and greater comprehension of the consent form. Coronary Artery Calcium (CAC) Score Sub-Study: At baseline visit, a total of 300 participants (150 with obesity and 150 without obesity) will undergo CT testing to determine coronary artery calcium (CAC) score. Basic Science Sub-Study: Thirty participants with obesity (15 high-risk for CV disease and 15 low-risk for CV disease) will participate in the basic science sub-study where additional blood will be drawn at baseline visit and at follow-up visit. This blood will be processed to isolate the endothelial colony forming cells and we will examine the effect of altered plasma branched chain amino acid (BCAA) levels on vascular function within these groups.
Interventions
BEHAVIORALDigital 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.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
Exclusion criteria
* Participants opted out of being contacted for research in Maestro Care * Pregnant at the time of enrollment or \<12 months post-partum * Prior bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Gut microbiome composition as measured by DNA sequencing | Baseline | — |
| 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%) |
| Change in lipid profile as measured by LDL | Baseline, End of intervention (up to 6 months) | — |
| Change in gut microbiome composition as measured by DNA sequencing | Baseline, End of intervention (up to 6 months) | — |
Countries
United States
Outcome results
None listed