ObesityRESILIENCENCT04551872
RESILIENCE: Personalizing Cardiovascular Health
A study testing Digital weight loss intervention in people with Obesity and Cardiovascular Risk Factor, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Risk Factor
- What is being tested?
- Digital weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Have an email address listed in the EHR
- Have access to MyChart
- Have a smartphone
- Be able to read and understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Personalizing Cardiovascular Health: A Population Approach to Promoting CVD Resistance and Resilience Among Individuals With Obesity
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.
Read the 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.
- Conditions
- Obesity, Cardiovascular Risk Factor
- Being tested
- Digital weight loss intervention
- Keywords
- Obesity, Translating Duke Health, RESILIENCE, CVD, DUHS, Duke, Heart Disease
- Medical subject headings
- Obesity, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital weight loss interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Obese High Risk | Experimental | 200 participants with BMI ≥30 and 10-year ASCVD risk ≥20% Receives: Behavioral: Digital weight loss intervention |
| Obese Low Risk | Experimental | 200 participants with BMI ≥30 and 10-year ASCVD risk <7.5% Receives: Behavioral: Digital weight loss intervention |
| Non-Obese High Risk | No intervention | 100 participants with BMI 18-25 and 10-year ASCVD risk ≥20% |
| Non-Obese Low Risk | No intervention | 100 participants with BMI 18-25 and 10-year ASCVD risk <7.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average branched-chain amino acid levels as measured by metabolomics analyses
Measured: Baseline
Change in branched-chain amino acid levels as measured by metabolomics analyses
Measured: Baseline, End of intervention (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start22 Sep 2020
- Primary completion22 Mar 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Pagidipati, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551872
- Sponsor's protocol ID
- Pro00104664
- Acronym
- RESILIENCE
- Status last verified
- Apr 2024
- First submitted
- 9 Sep 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rennyson K, Kenjale A, Chiswell K, Li Y, Uchehara B, Armstrong S, Goldstein B, Kelsey M, Hurdle M, McGarrah R, Nelson AJ, Patel M, Peterson ED, Roberts J, Truskey G, Douglas PS, Shah S, Pagidipati NJ. Design and Rationale of the pERSonalized cardIovascuLar dIsease prEvention, treatmeNt, and CarE (RESILIENCE) study. Contemp Clin Trials. 2026 Aug;167:108369. doi: 10.1016/j.cct.2026.108369. Epub 2026 Jun 4.
PubMed 42248410Gouda P, Glover L, Kenjale A, Chiswell K, Erickson T, Goldstein B, Kelsey M, Roberts J, Peterson ED, Patel M, Truskey G, Shah S, Douglas PS, Nelson AJ, J Pagidipati N. Messaging Modality and Content for Recruitment of Research Participants: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2614046. doi: 10.1001/jamanetworkopen.2026.14046.
PubMed 42172031Gouda P, Glover L, Kenjale A, Chiswell K, Erickson T, Goldstein B, Kelsey M, Roberts J, Peterson ED, Patel M, Truskey G, Shah S, Douglas PS, Nelson AJ, Pagidipati NJ. Audiovisual Augmentation of Electronic Consent to Improve Consent Rates and Comprehension: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e269347. doi: 10.1001/jamanetworkopen.2026.9347.
PubMed 42060306
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Cardiovascular Health: A Population Approach to Promoting CVD Resistance and Resilience Among Individuals With Obesity
- ClinicalTrials.gov ID
- NCT04551872
- Acronym / sponsor ID
- RESILIENCE / Pro00104664
- Conditions
- Obesity, Cardiovascular Risk Factor
- Keywords
- Obesity, Translating Duke Health, RESILIENCE, CVD, DUHS, Duke, Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese High Risk | Experimental | Behavioral: Digital weight loss intervention200 participants with BMI ≥30 and 10-year ASCVD risk ≥20% |
| Obese Low Risk | Experimental | Behavioral: Digital weight loss intervention200 participants with BMI ≥30 and 10-year ASCVD risk <7.5% |
| Non-Obese High Risk | No intervention | –100 participants with BMI 18-25 and 10-year ASCVD risk ≥20% |
| Non-Obese Low Risk | No intervention | –100 participants with BMI 18-25 and 10-year ASCVD risk <7.5% |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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%).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital weight loss interventionParticipants 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. | Behavioural | Obese High Risk, Obese Low Risk |
Primary outcome
Average branched-chain amino acid levels as measured by metabolomics analyses
Time frame: Baseline
Change in branched-chain amino acid levels as measured by metabolomics analyses
Time frame: Baseline, End of intervention (up to 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 42248410Rennyson K, Kenjale A, Chiswell K, Li Y, Uchehara B, Armstrong S, Goldstein B, Kelsey M, Hurdle M, McGarrah R, Nelson AJ, Patel M, Peterson ED, Roberts J, Truskey G, Douglas PS, Shah S, Pagidipati NJ. Design and Rationale of the pERSonalized cardIovascuLar dIsease prEvention, treatmeNt, and CarE (RESILIENCE) study. Contemp Clin Trials. 2026 Aug;167:108369. doi: 10.1016/j.cct.2026.108369. Epub 2026 Jun 4.
- Derived from this study: PubMed 42172031Gouda P, Glover L, Kenjale A, Chiswell K, Erickson T, Goldstein B, Kelsey M, Roberts J, Peterson ED, Patel M, Truskey G, Shah S, Douglas PS, Nelson AJ, J Pagidipati N. Messaging Modality and Content for Recruitment of Research Participants: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2614046. doi: 10.1001/jamanetworkopen.2026.14046.
- Derived from this study: PubMed 42060306Gouda P, Glover L, Kenjale A, Chiswell K, Erickson T, Goldstein B, Kelsey M, Roberts J, Peterson ED, Patel M, Truskey G, Shah S, Douglas PS, Nelson AJ, Pagidipati NJ. Audiovisual Augmentation of Electronic Consent to Improve Consent Rates and Comprehension: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e269347. doi: 10.1001/jamanetworkopen.2026.9347.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Pagidipati, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital weight loss intervention in people with Obesity and Cardiovascular Risk Factor, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average branched-chain amino acid levels as measured by metabolomics analyses (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04551872, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.