Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

Study Overview
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Brief Summary
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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.

Official Title
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Phase II: Healthy Bodies, Hearts After Menopause

Conditions
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Obesity, Cardiovascular Disease, High Blood Pressure

Intervention / Treatment
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* Behavioral: In Person
* Behavioral: At Home


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: At Home<br>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. | Behavioral: At Home<br>* 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.<br>|
| Experimental: In Person<br>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). | Behavioral: In Person<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | The goal of the intervention is for participants to have a 10% reduction in body weight | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase physical activity | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women, Menopause, Cardiovascular Disease, Physical Activity, Weight Loss