NCT00169312

Brief Summary

RATIONALE: Websites for nutrition education may be an effective method to help people eat more fruits and vegetables which may lower their risk of cancer. PURPOSE: This randomized trial is studying how well an internet-based nutrition education program works in preventing cancer in participants of health maintenance organizations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,619

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2009

First QC Date

September 13, 2005

Last Update Submit

September 19, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention

Secondary Outcomes (2)

  • Change in the number of daily fruit and vegetable servings consumed at the 3- and 6-month post-intervention assessments

  • Proportion of participants who achieve an intake of 5 or more daily fruit and vegetable servings by 12 months

Interventions

behavioral dietary interventionBEHAVIORAL
dietary interventionDIETARY_SUPPLEMENT
educational interventionOTHER
internet-based interventionOTHER
preventative dietary interventionOTHER
evaluation of cancer risk factorsPROCEDURE

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Current member of any of the following participating health maintenance organizations: * Group Health Cooperative * Kaiser Permanente, Colorado * Kaiser Permanante, Georgia * HealthPartners Research Foundation * Henry Ford Health System/Health Alliance Plan * Must complete a web-based health survey prior to randomization PATIENT CHARACTERISTICS: * No medical or mental health condition that would be adversely affected by increased vegetable and fruit intake * One participant allowed per household PRIOR CONCURRENT THERAPY: * No concurrent anticoagulation therapy (e.g., warfarin) * No other concurrent medications that would be adversely affected by increased vegetable and fruit intake * No grapefruit concurrently with any of the following medications: * Statin for high cholesterol * Blood pressure medications (e.g., Losartan) * Calcium channel blockers * Certain psychiatric medications (e.g., buspirone hydrochloride, triazolam \[Halcion\], carbamazepine, diazepam \[Valium\], or midazolam hydrochloride) * Immune suppressants (e.g., cyclosporine or tacrolimus) * Impotence medications (e.g., sildenafil \[Viagra\]) * Methadone

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

Sponsors & Collaborators

Study Sites (4)

Kaiser Permanente - Colorado

Denver, Colorado, United States

Location

Kaiser Permanente, Georgia

Atlanta, Georgia, United States

Location

HealthPartners Research Foundation

Minneapolis, Minnesota, United States

Location

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • Stopponi MA, Alexander GL, McClure JB, Carroll NM, Divine GW, Calvi JH, Rolnick SJ, Strecher VJ, Johnson CC, Ritzwoller DP. Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants. J Med Internet Res. 2009 Aug 26;11(3):e38. doi: 10.2196/jmir.1086.

    PMID: 19709990BACKGROUND

  • Couper MP, Alexander GL, Zhang N, Little RJ, Maddy N, Nowak MA, McClure JB, Calvi JJ, Rolnick SJ, Stopponi MA, Cole Johnson C. Engagement and retention: measuring breadth and depth of participant use of an online intervention. J Med Internet Res. 2010 Nov 18;12(4):e52. doi: 10.2196/jmir.1430.

    PMID: 21087922DERIVED

MeSH Terms

Interventions

Diet TherapyEarly Intervention, Educational

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Christine Cole Johnson, PhD

    Josephine Ford Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Study Completion

June 1, 2007

Last Updated

September 20, 2013

Record last verified: 2009-09

Locations

US(4)