Clinical & Web-based Diet & Activity Counseling for Men

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00412633
First received: December 15, 2006
Last updated: June 8, 2012
Last verified: June 2012

December 15, 2006
June 8, 2012
February 2004
July 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00412633 on ClinicalTrials.gov Archive Site
  • 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 ]
  • The secondary aims of this study are:
  • 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.
  • evaluate the impact of the intervention on physical activity
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Clinical & Web-based Diet & Activity Counseling for Men
Clinical & Web-based Diet & Activity Counseling for Men

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Behavioral: Diet and physical activity interventions
    Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
  • Behavioral: Computer technology to tailor, promote and sustain health behavior change & improve health care delivery.
    Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
October 2010
July 2007   (final data collection date for primary outcome measure)

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.
Male
25 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00412633
R01 CA98861, UCSD# 2007-0166
Not Provided
Kevin Patrick - PI, UCSD
University of California, San Diego
Not Provided
Principal Investigator: Kevin Patrick, MD, MS UCSD
University of California, San Diego
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP