NCT00412633

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

3.4 years

First QC Date

December 15, 2006

Last Update Submit

June 8, 2012

Conditions

Keywords

ObesityMenOverweight

Outcome Measures

Primary Outcomes (1)

  • 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

    12 Months

Secondary Outcomes (2)

  • 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 activity

    12 months

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.

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

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • More severely obese participants will be excluded because they may need more intense behavioral, pharmacological or surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityMultiple Endocrine Neoplasia Type 1Overweight

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kevin Patrick, MD, MS

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2006

First Posted

December 18, 2006

Study Start

February 1, 2004

Primary Completion

July 1, 2007

Study Completion

October 1, 2010

Last Updated

June 11, 2012

Record last verified: 2012-06