Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

Phase II: Healthy Bodies, Hearts After Menopause

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01099007

Acronym

HBHH

Enrollment

Registered

2010-04-06

Start date

2009-06-30

Completion date

2011-02-28

Last updated

2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Cardiovascular Disease, High Blood Pressure

Keywords

Women, Menopause, Cardiovascular Disease, Physical Activity, Weight Loss

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.

Interventions

BEHAVIORALIn 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).

BEHAVIORALAt 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026