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Help Everyone Assess Risk Today: LEnten Nutrition Study (HEART-LENS)

NCT05057650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-10-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically improves their lifestyle by "giving up for Lent" certain foods or habits. Participation in this nutrition intervention is voluntary and each participant will sign an informed consent along with a waiver. On the waiver, the participant can agree to have all testing performed but can withdraw consent at any time or decide to have only some of the testing.

It was hypothesized that a community-based health screening and nutritional intervention will have a positive impact on the participants by:

1. Measuring baseline risk factors
2. Educating them about their individual risk for heart disease
3. Providing education on healthy lifestyle
4. Providing a nutritional intervention for 40 days with home- delivered plant-based meals nutrition that has been shown to lower cardiac risk factors
5. Repeating the risk factor assessment at the end of the intervention, to demonstrate the degree of, if any, reduction in cardiac risk as assessed by the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator
6. Motivating at-risk subjects to seek continued appropriate medical care and to institute more permanent relevant lifestyle changes (e.g., diet, exercise, medication compliance).

Conditions

  • Cardiovascular Morbidity
  • Risk Reduction
  • Nutrition Disorders

Interventions

DIETARY_SUPPLEMENT

Vegan diet

Provide

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-03
Primary Completion
2019-04-20
Completion
2020-03-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057650 on ClinicalTrials.gov