Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

Phase 1

Completed

• Conditions: Obesity; High Blood Pressure; Cardiovascular Disease
• Interventions: Behavioral: At Home; Behavioral: In Person

• Registration Number: NCT01099007
• Lead Sponsor: University of Pittsburgh

Brief Summary

The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. Participants will be randomly assigned to a group.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-02
• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Study Completion: 2011-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• Not currently exercising for at least 100 minutes per week
• Have a Body Mass Index (BMI) of 25 or greater
• Has a physician in one of the three participating practices

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Exclusion Criteria

• Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
At Home	At Home	Participants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own.
In Person	In Person	Participants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking).

Primary Outcome Measures

Name	Time	Method
Weight loss	6 months	The goal of the intervention is for participants to have a 10% reduction in body weight

Secondary Outcome Measures

Name	Time	Method
Increase physical activity	3 months	The goal of the study is for participants to reach and maintain an average of 150 minutes of moderate to brisk physical activity per week.

Trial Locations

Locations (1)

UPMC Montefiore Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States