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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00301691
First received: March 9, 2006
Last updated: July 9, 2013
Last verified: May 2006
  Purpose

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.


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: Tailoring Nutrition Education for Low-Income Audiences

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 7 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 7 months [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: September 2000
Study Completion Date: May 2006
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.

  Eligibility

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

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
  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: NCT00301691

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00301691     History of Changes
Other Study ID Numbers: BUSM-R01-CA81828, CDR0000453534
Study First Received: March 9, 2006
Last Updated: July 9, 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 September 18, 2014