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Clinical & Web-based Diet & Activity Counseling for Men

Clinical & Web-based Diet & Activity Counseling for Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00412633
Enrollment
442
Registered
2006-12-18
Start date
2004-02-29
Completion date
2010-10-31
Last updated
2012-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Men, Overweight

Brief summary

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.

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.

Interventions

BEHAVIORALDiet 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.

BEHAVIORALComputer 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.

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frame
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 consumed12 Months

Secondary

MeasureTime frame
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.12 months
evaluate the impact of the intervention on physical activity12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026