Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128570
Status:
COMPLETED
Last Update Posted:
2013-09-17
First Post:
2005-08-08
Brief Title:
An Individualized Internet-Based Health Behavior Program or a Standard Internet-Based Health Behavior Program in Preventing Cancer and Improving Physical Activity and Nutrition in Participants Who Are Physically Inactive With a Higher Body Mass Index
Sponsor:
Virginia Polytechnic Institute and State University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Cancer Prevention Mastery Model Internet Intervention
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
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 An internet-based health behavior program that provides information about physical activity fitness and nutrition may help participants become healthier and reduce the risk of developing cancer
PURPOSE This randomized clinical trial is studying an individualized internet-based health behavior program to see how well it works compared to a standard internet-based health behavior program in preventing cancer and improving physical activity fitness and nutrition in participants who are physically inactive with a higher body mass index
PURPOSE This randomized clinical trial is studying an individualized internet-based health behavior program to see how well it works compared to a standard internet-based health behavior program in preventing cancer and improving physical activity fitness and nutrition in participants who are physically inactive with a higher body mass index
Detailed Description:
OBJECTIVES
Compare the efficacy of an internet-based mastery-model health behavior educational intervention vs internet-based standard care health behavior educational intervention in improving physical activity and nutrition in sedentary participants with a higher body mass index
Compare the efficacy of these interventions in reducing cancer risk in these participants
OUTLINE This is a randomized controlled multicenter study Participants are stratified according to participating site age 55 years and over vs under 55 years gender ethnic group and aerobic capacity 6 metabolic equivalent tasks METS vs 6 METS Participants are randomized to 1 of 2 intervention arms
Arm I mastery model health behavior educational intervention Participants log on to the Guide to Health Project GTH website weekly and are provided access over a 24-month period to healthy lifestyle coaching modules and a completely individualized fitness program organized according to a mastery-model health behavior educational intervention The mastery-model intervention comprises a 6-month behavioral initiation phase that includes an orientation and refinement of goals and expectations for each content area a 6-month behavioral establishment phase comprising healthy lifestyle coaching modules focusing on physical activity and nutrition at least once a week and a 6-month behavioral maintenance phase comprising a taper in the frequency of coaching sessions to once a month
Arm II standard care health behavior educational intervention Participants log on to the GTH website weekly and are provided access over a 24-month period to information regarding a healthy lifestyle focusing on physical activity and nutrition organized according to a standard care health behavior educational intervention
In both arms participants verify step-counts measured by a pedometer and complete the Block Food Frequency Questionnaire online at 10 and 18 months
PROJECTED ACCRUAL A total of 300 participants 150 per arm will be accrued for this study within 1 year
Compare the efficacy of an internet-based mastery-model health behavior educational intervention vs internet-based standard care health behavior educational intervention in improving physical activity and nutrition in sedentary participants with a higher body mass index
Compare the efficacy of these interventions in reducing cancer risk in these participants
OUTLINE This is a randomized controlled multicenter study Participants are stratified according to participating site age 55 years and over vs under 55 years gender ethnic group and aerobic capacity 6 metabolic equivalent tasks METS vs 6 METS Participants are randomized to 1 of 2 intervention arms
Arm I mastery model health behavior educational intervention Participants log on to the Guide to Health Project GTH website weekly and are provided access over a 24-month period to healthy lifestyle coaching modules and a completely individualized fitness program organized according to a mastery-model health behavior educational intervention The mastery-model intervention comprises a 6-month behavioral initiation phase that includes an orientation and refinement of goals and expectations for each content area a 6-month behavioral establishment phase comprising healthy lifestyle coaching modules focusing on physical activity and nutrition at least once a week and a 6-month behavioral maintenance phase comprising a taper in the frequency of coaching sessions to once a month
Arm II standard care health behavior educational intervention Participants log on to the GTH website weekly and are provided access over a 24-month period to information regarding a healthy lifestyle focusing on physical activity and nutrition organized according to a standard care health behavior educational intervention
In both arms participants verify step-counts measured by a pedometer and complete the Block Food Frequency Questionnaire online at 10 and 18 months
PROJECTED ACCRUAL A total of 300 participants 150 per arm will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VPISU-03-588 | None | None | None |
| VPISU-04-644 | None | None | None |