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

Sponsors and Collaborators:	Brown University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301691

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

MedlinePlus related topics: Cancer Diets

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
Official Title:	Tailoring Nutrition Education for Low-Income Audiences

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

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Kim M. Gans, PhD, MPH, LDN

Brown University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000453534, BUSM-R01-CA81828
Study First Received:	March 9, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00301691 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009