NCT00301691

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

July 10, 2013

Status Verified

May 1, 2006

First QC Date

March 9, 2006

Last Update Submit

July 9, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 7 months

Secondary Outcomes (1)

  • 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

Interventions

behavioral dietary interventionBEHAVIORAL
educational interventionOTHER
preventative dietary interventionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Medicine

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Gans KM, Risica PM, Strolla LO, Fournier L, Kirtania U, Upegui D, Zhao J, George T, Acharyya S. Effectiveness of different methods for delivering tailored nutrition education to low income, ethnically diverse adults. Int J Behav Nutr Phys Act. 2009 May 5;6:24. doi: 10.1186/1479-5868-6-24.

    PMID: 19416525DERIVED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Kim M. Gans, PhD, MPH, LDN

    Brown University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 13, 2006

Study Start

September 1, 2000

Study Completion

May 1, 2006

Last Updated

July 10, 2013

Record last verified: 2006-05

Locations

US(1)