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

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ClinicalTrials.gov Identifier: NCT00169312
Recruitment Status : Unknown
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: behavioral dietary intervention Dietary Supplement: dietary intervention Other: educational intervention Other: internet-based intervention Other: preventative dietary intervention Procedure: evaluation of cancer risk factors Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2619 participants
Allocation: Randomized
Masking: Single
Official Title: The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study
Study Start Date : August 2005
Study Completion Date : June 2007
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention

Secondary Outcome Measures :
  1. Change in the number of daily fruit and vegetable servings consumed at the 3- and 6-month post-intervention assessments
  2. Proportion of participants who achieve an intake of 5 or more daily fruit and vegetable servings by 12 months

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169312


Locations
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United States, Colorado
Kaiser Permanente - Colorado
Denver, Colorado, United States
United States, Georgia
Kaiser Permanente, Georgia
Atlanta, Georgia, United States
United States, Minnesota
HealthPartners Research Foundation
Minneapolis, Minnesota, United States
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Josephine Ford Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christine Cole Johnson, PhD Josephine Ford Cancer Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00169312    
Other Study ID Numbers: CDR0000514226
HFH-B40389
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2009
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific