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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301678
First received: March 9, 2006
Last updated: September 16, 2013
Last verified: May 2007
  Purpose

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 Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: behavioral dietary intervention
Other: educational intervention
Other: preventative dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Innovative Video Tailoring for Dietary Change

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 8 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 2520
Study Start Date: June 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301678

Locations
United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Investigators
Study Chair: Kim M. Gans, PhD, MPH, LDN Brown University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00301678     History of Changes
Other Study ID Numbers: CDR0000453539, BUSM -0348-03, RWMC-0348-03
Study First Received: March 9, 2006
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014