Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

NCT ID: NCT01099007

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-02-28

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.

Conditions

Obesity; Cardiovascular Disease; High Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

At Home

Intervention Type: BEHAVIORAL

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

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).

Group Type: EXPERIMENTAL

In Person

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

5K23HL085405-03

Identifier Type: NIH

Identifier Source: secondary_id

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HL085405

Identifier Type: -

Identifier Source: org_study_id