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
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|
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||2619 participants|
|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|
- Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention
- 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
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
|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|
|Principal Investigator:||Christine Cole Johnson, PhD||Josephine Ford Cancer Center|