NCT00005727

Brief Summary

To conduct a randomized, controlled trial of cardiovascular disease nutrition education using a cluster design with two conditions, special intervention (SI) and usual care (UC).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
351

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
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1995

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2000

Completed
5 months 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

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

4.3 years

First QC Date

May 25, 2000

Last Update Submit

August 23, 2016

Conditions

Cardiovascular DiseasesHeart Diseases

Keywords

NutritionEducation

Study Arms (2)

Intervention

EXPERIMENTAL

Specially-designed nutrition education curriculum designed to lower dietary fat intake in people with low literacy skills.

Behavioral: Intervention

Control

ACTIVE COMPARATOR

General nutrition education curriculum.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

Classroom-based nutrition education curriculum designed for individuals with low literacy skills.

ControlIntervention

Eligibility Criteria

AgeUp to 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

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

Sponsors & Collaborators

Related Publications (2)

  • Howard-Pitney B, Winkleby MA, Albright CL, Bruce B, Fortmann SP. The Stanford Nutrition Action Program: a dietary fat intervention for low-literacy adults. Am J Public Health. 1997 Dec;87(12):1971-6. doi: 10.2105/ajph.87.12.1971.

    PMID: 9431286BACKGROUND

  • Winkleby MA, Howard-Pitney B, Albright CA, Bruce B, Kraemer HC, Fortmann SP. Predicting achievement of a low-fat diet: a nutrition intervention for adults with low literacy skills. Prev Med. 1997 Nov-Dec;26(6):874-82. doi: 10.1006/pmed.1997.0231.

    PMID: 9388800BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
C.F. Rehnborg Professor in Disease Prevention, Emeritus

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

August 1, 1991

Primary Completion

December 1, 1995

Study Completion

January 1, 2000

Last Updated

August 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share