Clinical & Web-based Diet & Activity Counseling for Men
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Diet and physical activity interventions Behavioral: Computer technology to tailor, promote and sustain health behavior change & improve health care delivery. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical & Web-based Diet & Activity Counseling for Men |
- 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 ]
- evaluate at 12 months the impact of the intervention on three additional dietary behavior outcomes: (a)fiber intake (b)total energy intake, and (c) total fat as a percent of energy consumed. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- evaluate the impact of the intervention on physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 442 |
| Study Start Date: | February 2004 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
-
Behavioral: Diet and physical activity interventions
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.
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects will be 360 men age 25 through 55 years with BMIs of 25 to 39.9 (those characterized as "overweight" or "obese I" in the recent NIH report on Obesity).
Exclusion Criteria:
- More severely obese participants will be excluded because they may need more intense behavioral, pharmacological or surgical intervention.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Kevin Patrick - PI, UCSD |
| ClinicalTrials.gov Identifier: | NCT00412633 History of Changes |
| Other Study ID Numbers: | R01 CA98861, UCSD# 2007-0166 |
| Study First Received: | December 15, 2006 |
| Last Updated: | June 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Obesity Men Overweight |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013