Internet-Based Nutrition Education Program in Preventing Cancer in Participants of Health Maintenance Organizations

September 19, 2013 updated by: Josephine Ford Cancer Center

The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Compare the effects of internet-based nutrition education through untailored websites vs tailored websites (TW) vs TW and tailored human online behavioral interaction (HOBI) on the change in the number of daily fruit and vegetable servings consumed in participants of health maintenance organizations.

Secondary

  • Compare the proportion of participants reporting consumption of 5 or more servings of fruits and vegetables per day at each 3-month interval.
  • Compare the change in fruit and vegetable servings consumed from baseline to each intermediate time point.
  • Compare the effects of intervention and observation time in these participants.
  • Determine the effect of HOBI in these participants.
  • Compare the impact of participant characteristics, in terms of the effect of the intervention on the change in fruit and vegetable intake, in these participants.

OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Participants are stratified according to participating site, gender, and the participant's stage of change readiness. Participants are randomized to 1 of 3 intervention arms.

  • Arm I (untailored websites): Participants are given unlimited access to an internet-based nutrition education program for up to 6 months. They are provided with 4 serial educational websites at 1, 3, 13, and 15 weeks after initial login. These internet sites provide general information about fruits and vegetables, new recipes with emphasis on fruits and vegetables, and how participants can incorporate them into their diet. Participants complete an online survey at 3 months.
  • Arm II (tailored websites): Participants are given unlimited access to an internet-based nutrition education program for up to 6 months. They are provided with 4 serial educational websites, at the same timepoints as in arm I, with emphasis on vegetable consumption in weeks 1 and 13 and fruit consumption in weeks 3 and 15. Materials in these websites, including new recipes with emphasis on fruits and vegetables, are tailored and then revised (or retailored) based on individual health-risk information obtained at baseline and at the 3-month online survey.
  • Arm III (tailored websites and human online behavioral interaction [HOBI]): Participants are given unlimited access to an internet-based nutrition education program for up to 6 months. Participants are provided with 4 serial educational websites with tailored materials as in arm II. They also receive HOBI (tailored e-mail messages) developed and then revised based on health-risk information obtained at baseline and the 3-month online survey.

In all arms, participants complete online surveys at 3, 6, and 12 months to measure fruit and vegetable intake and change in long-term risk behavior. For each survey, participants receive up to 6 automatically generated reminder e-mails and 1 mailed announcement.

PROJECTED ACCRUAL: A total of 2,619 participants were accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

2619

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States
        • Kaiser Permanente - Colorado
    • Georgia
      • Atlanta, Georgia, United States
        • Kaiser Permanente, Georgia
    • Minnesota
      • Minneapolis, Minnesota, United States
        • HealthPartners Research Foundation
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Cooperative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josephine Ford Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Christine Cole Johnson, PhD, Josephine Ford Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000514226
  • HFH-B40389

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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