Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial (HBHH)

University of Pittsburgh

Status and phase: Completed; Phase 1

Conditions: High Blood Pressure; Obesity; Cardiovascular Disease

Treatments: Behavioral: At Home; Behavioral: In Person

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01099007

5K23HL085405-03 (U.S. NIH Grant/Contract)

HL085405

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

At Home

Active Comparator group

Description:

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.

Treatment:

Behavioral: At Home

In Person

Experimental group

Description:

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).

Treatment:

Behavioral: In Person