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.

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Key information

Conditions

Obesity Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet and physical activity interventions

Behavioral

Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.

Computer technology to tailor, promote and sustain health behavior change & improve health care delivery.

Behavioral

Weekly web-based intervention that included goal setting, self-monitoring, weekly behavioral skills, nutrition and physical activity tips, and access to a health coach.

Primary outcomes

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

Secondary outcomes

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
evaluate the impact of the intervention on physical activity

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2010
First posted: Dec 18, 2006
Registry last updated: Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed