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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301678
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2006
Last Update Posted : September 17, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: behavioral dietary intervention Other: educational intervention Other: preventative dietary intervention Not Applicable

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 2520 participants
Allocation: Randomized
Primary Purpose: Prevention
Official Title: Innovative Video Tailoring for Dietary Change
Study Start Date : June 2001

Primary Outcome Measures :
  1. Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 8 months

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


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


  • 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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301678

United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
National Cancer Institute (NCI)
Study Chair: Kim M. Gans, PhD, MPH, LDN Brown University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00301678     History of Changes
Other Study ID Numbers: CDR0000453539
BUSM -0348-03
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific