Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169312
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2005-09-13
Brief Title:
Internet-Based Nutrition Education Program in Preventing Cancer in Participants of Health Maintenance Organizations
Sponsor:
Josephine Ford Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
The HMO Cancer Research Network CRN - Making Effective Nutritional Choices for Cancer Prevention The MENU Study
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This randomized trial is studying how well an internet-based nutrition education program works in preventing cancer in participants of health maintenance organizations
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 participants 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 2619 participants were accrued for this study
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 participants 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 2619 participants were accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HFH-B40389 | None | None | None |