Nutrition Education for Low-Income Healthy Participants Who Eat an Unhealthy Diet

July 9, 2013 updated by: Brown University

Tailoring Nutrition Education for Low-Income Audiences

RATIONALE: Decreasing the amount of fat in the diet and increasing fruit and vegetable intake may help prevent some types of cancer. Giving low-income participants easy-to-read written nutrition materials and an instructional and motivational videotape may help improve eating habits.

PURPOSE: This randomized clinical trial is studying how well nutrition education improves the eating habits of low-income healthy participants who eat an unhealthy diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Test culturally and linguistically appropriate English and Spanish language versions of a motivational and instructional video and low literacy written nutrition materials that focus on improving eating habits, particularly decreasing fat consumption and increasing fruit and vegetable intake in non-Hispanic and Hispanic low-income participants, to determine which intervention components are most effective in decreasing fat intake and increasing fruit and vegetable intake.
  • Determine if participants who receive tailored nutrition information in several mailings (MT) decrease their fat consumption and increase their fruit and vegetable intake more than participants who receive such information in one mailing (ST).
  • Determine if participants who receive tailored nutrition information in several sequential "interactively retailored" mailings (MTI) decrease their fat consumption and increase their fruit and vegetable intake more than MT participants.
  • Compare dietary change achieved from the above tailored educational approaches with a comparison group that receives nontailored written nutritional materials (NT).
  • Compare the differential costs of the above tailored educational approaches.
  • Study the results of the randomized trial in terms of specific eating behaviors, stage of change, self-efficacy, decisional balance, and barriers to making dietary changes.

OUTLINE: This is a randomized, controlled study.

Participants complete a baseline interview. A subset of participants completes a second interview at baseline. Participants are then randomized to 1 of 4 education arms.

  • Arm I (non-tailored written nutrition materials): Participants receive non-tailored written nutrition information in 1 installment.
  • Arm II (tailored nutrition information): Participants receive tailored written nutrition information in 1 installment. Participants also receive a motivational and instructional video.
  • Arm III (tailored nutrition information in multiple mailings): Participants receive tailored written nutrition information in 4 smaller installments over 12 weeks. Participants also receive a motivational and instructional video.
  • Arm IV (multiple sequential "interactively tailored" mailings): Participants receive tailored written nutrition information and a motivational and instructional video as in arm III. Participants may mail in follow-up assessments in order to retailor the information they receive in later installments.

After completion of study intervention, patients are followed at 4 and 7 months.

PROJECTED ACCRUAL: A total of 2,000 participants will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Healthy low income participant who eats an unhealthy diet
  • Not already on a healthy diet

PATIENT CHARACTERISTICS:

  • Able to read basic Spanish or English
  • Not pregnant
  • No acute or chronic medical condition which would prevent participant from making basic healthful dietary changes
  • No significant visual and/or hearing impairments
  • Not from the same household as another study participant

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 7 months

Secondary Outcome Measures

Outcome Measure
Mediators and moderators of behavioral change by adapted scales for stage of change, self-efficacy, barriers, and facilitators at baseline, 4 months, and 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Kim M. Gans, PhD, MPH, LDN, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion

December 7, 2022

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

March 9, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BUSM-R01-CA81828
  • CDR0000453534 (Registry Identifier: PDQ (Physician Data Query))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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