NCT00005724

Brief Summary

To develop cardiovascular disease nutrition modules tailored to subjects with low literacy skills.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
369

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 1991

Longer than P75 for not_applicable cardiovascular-diseases

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

Study Start

First participant enrolled

August 1, 1991

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1995

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 1996

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

May 25, 2000

Last Update Submit

April 17, 2017

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Total cholesterol

    3-month follow-up

Study Arms (3)

Minimal Intervention Group

OTHER

Pamphlets on healthy eating mailed to participants.

Other: Minimal Intervention Group

Health Counselor Intervention Group

EXPERIMENTAL

Food for Heart program, a structured diet treatment program for low-income patients with high cholesterol, given by health counselor at 4 treatment visits.

Behavioral: Health Counselor Intervention Group

Computer Program Intervention Group

EXPERIMENTAL

User-friendly interactive computer program providing dietary counseling tailored to the needs of the participant.

Behavioral: Computer Program Intervention Group

Interventions

Computer Program Intervention GroupBEHAVIORAL

A user-friendly, interactive computer program providing dietary counseling tailored to the needs of the participant.

Computer Program Intervention Group
Minimal Intervention GroupOTHER

Dietary Information pamphlets.

Minimal Intervention Group
Health Counselor Intervention GroupBEHAVIORAL

Food for Heart Program - a structured diet treatment program for low income patients with high cholesterol, given by a health counselor at 4 treatment visits.

Health Counselor Intervention Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Must have high cholesterol; Low-literacy skills; Must be patient at one of 9 community health centers recruited for study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Thomas Keyserling, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

August 1, 1991

Primary Completion

July 1, 1995

Study Completion

July 31, 1996

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share