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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
  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

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412633

Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kevin Patrick, MD, MS UCSD
  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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014