Clinical & Web-based Diet & Activity Counseling for Men
| Tracking Information | |||||
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| First Received Date ICMJE | December 15, 2006 | ||||
| Last Updated Date | June 8, 2012 | ||||
| Start Date ICMJE | February 2004 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The effect of the intervention on 3 behavioral outcomes: energy expended in moderate and vigorous physical activity during leisure, (b) fruit and vegetable intake, and (c) decreased saturated fat as a percent of energy consumed [ Time Frame: 12 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To evaluate the effects of an integrated primary care and Web-based intervention to improve physical activity and dietary behaviors in overweight and moderately obese men. | ||||
| Change History | Complete list of historical versions of study NCT00412633 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical & Web-based Diet & Activity Counseling for Men | ||||
| Official Title ICMJE | Clinical & Web-based Diet & Activity Counseling for Men | ||||
| Brief Summary | PACE Project researchers at UCSD are conducting a 2-year study to test the Men in Motion program. The study aims to learn more about how to help men lose weight, become more physically active, and improve their dietary habits. The study is sponsored by the National Institutes of Health. |
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| Detailed Description | This is a randomized controlled trial that will evaluate the effects of a Web-based intervention to improve physical activity and dietary behaviors in overweight and moderately obese men age 25 through 55 years. The study will complement our currently funded NCI project evaluating a similar intervention among overweight female primary care patients. Overweight is related to multiple cancers, CVD, and NIDDM, and the prevalence of overweight is increasing rapidly (NIH 1998). Patient-centered Assessment and Counseling for Exercise plus Nutrition - Internet (PACEi) targets weight-related behaviors and gives patients a tool for addressing these behaviors with their primary care practitioners should they choose to do so. PACEi includes a web-based assessment and progress planning tool, and 12 months of tailored Internet and telephone contact. The components are integrated through a common theoretical framework. Subjects will be randomized to PACEi or to a low intensity intervention. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 442 | ||||
| Completion Date | October 2010 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 25 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00412633 | ||||
| Other Study ID Numbers ICMJE | R01 CA98861, UCSD# 2007-0166 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Kevin Patrick - PI, UCSD | ||||
| Study Sponsor ICMJE | University of California, San Diego | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Diego | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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