NCT00301678

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2,520

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2001

Completed
4.8 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
Last Updated

September 17, 2013

Status Verified

May 1, 2007

First QC Date

March 9, 2006

Last Update Submit

September 16, 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 8 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 8 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 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

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, Dulin-Keita A, Mello J, Dawood M, Strolla LO, Harel O. Innovative video tailoring for dietary change: final results of the Good for you! cluster randomized trial. Int J Behav Nutr Phys Act. 2015 Oct 7;12:130. doi: 10.1186/s12966-015-0282-5.

    PMID: 26445486DERIVED

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

June 1, 2001

Last Updated

September 17, 2013

Record last verified: 2007-05

Locations

US(1)