Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00169312
First received: September 13, 2005
Last updated: September 19, 2013
Last verified: September 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Official Title: The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the number of daily fruit and vegetable servings consumed at the 3- and 6-month post-intervention assessments [ Designated as safety issue: No ]
  • Proportion of participants who achieve an intake of 5 or more daily fruit and vegetable servings by 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 2619
Study Start Date: August 2005
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169312

Locations
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 at Henry Ford Hospital
Investigators
Principal Investigator: Christine Cole Johnson, PhD Josephine Ford Cancer Center at Henry Ford Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00169312     History of Changes
Other Study ID Numbers: CDR0000514226, HFH-B40389
Study First Received: September 13, 2005
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on November 20, 2014