NCT04551872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

September 22, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

September 9, 2020

Last Update Submit

April 23, 2024

Conditions

ObesityCardiovascular Risk Factor

Keywords

ObesityTranslating Duke HealthRESILIENCECVDDUHSDukeHeart Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (26)

  • 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

  • +23 more other outcomes

Study Arms (4)

Obese High Risk

EXPERIMENTAL

200 participants with BMI ≥30 and 10-year ASCVD risk ≥20%

Behavioral: Digital weight loss intervention

Obese Low Risk

EXPERIMENTAL

200 participants with BMI ≥30 and 10-year ASCVD risk \<7.5%

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%

Interventions

Digital weight loss interventionBEHAVIORAL

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.

Obese High RiskObese Low Risk

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

ObesityHeart Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCardiovascular Diseases

Study Officials

  • Neha Pagidipati, MD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

September 22, 2020

Primary Completion

March 22, 2023

Study Completion

March 22, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)