Clinical & Web-Based Diet & Activity Counseling for Men - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00412633

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.

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical & Web-Based Diet & Activity Counseling for Men

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

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	360
Study Start Date:	February 2004
Estimated Study Completion Date:	June 2007

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

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

Study ID Numbers:	R01 CA98861, UCSD# 2007-0166
Study First Received:	December 15, 2006
Last Updated:	December 15, 2006
ClinicalTrials.gov Identifier:	NCT00412633
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Obesity
Men
Overweight

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 14, 2009