Personalized Nutrition Education in Improving Eating Habits of Healthy Participants Who Eat an Unhealthy Diet

September 16, 2013 updated by: Brown University

Innovative Video Tailoring for Dietary Change

RATIONALE: Decreasing the amount of fat in the diet and increasing fruit, vegetable, and fiber intake may help prevent some types of cancer. Giving participants easy-to-read personalized written nutrition materials and a personalized videotape may help improve eating habits.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Develop and test an innovative intervention (tailored "take-home" video tapes with accompanying low literacy tailored written materials) to help participants improve their eating habits, particularly decreasing fat and increasing fiber, fruit, and vegetable intake.
  • Determine the feasibility and acceptability of the above approach with work sites using process measures.
  • Conduct a randomized controlled trial to test the effectiveness of this approach in achieving dietary change relevant to cancer prevention, as compared to written tailored materials only or usual care materials.
  • Compare the differential costs of the above educational approaches.
  • Study cognitive/behavioral (psychosocial) factors associated with decreasing fat and increasing fruit and vegetable consumption.

OUTLINE: This is a multicenter, controlled study.

Nutrition education materials will be mailed out in 3 different sets and will vary depending on which of three experimental conditions the company is assigned. The groups are: Non-Tailored Written (NT), Tailored Written (TW) , or Tailored Written and Video (TV).

  • Group 1 (non-tailored written): Employee receives three sets of written information on nutrition and other health topics by mail. Upon completion of th study, participants in this group will receive a packet of written nutrition materials similar to what the other study groups received.
  • Group 2 (tailored written): Employee receives three sets of tailored written nutrition materials in the mail. These written materials will be designed especially for each employee. They will be based on their answers to the first telephone survey, and from two later brief sets of questions.
  • Group 3 (tailored written and video): Employee receives three sets of written nutrition materials and three videos or DVDs in the mail. The written materials and the video/DVD will be designed especially for each employee. They will be based on their answers to the first telephone survey and from two later brief sets of questions.

All participants receive booster intervention materials by mail at 2 and 4 months after baseline, following the same procedures as before. Participants receive follow-up telephone calls at 4 and 8 months after baseline.

PROJECTED ACCRUAL: A total of 2,520 participants will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

2520

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

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Healthy participants who eat an unhealthy diet
  • Employee at a work site

PATIENT CHARACTERISTICS:

  • Able to speak and read English
  • Not pregnant
  • No acute or chronic medical condition that would prevent making basic healthful dietary changes
  • Not already on healthy diet
  • No significant visual and/or hearing impairments
  • Not from the same household as another participant in this study

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 8 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 8 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

June 1, 2001

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)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000453539
  • BUSM -0348-03
  • RWMC-0348-03

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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