Skip to main content
OpenTrials
Completed

NCT Number: NCT01099007

Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Cardiovascular Disease Cardiovascular Diseases High Blood Pressure Hypertension Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Weight Loss

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In person

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).

At Home

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.

Primary outcomes

  1. Weight loss

    Time frame: 6 months

    The goal of the intervention is for participants to have a 10% reduction in body weight

Secondary outcomes

  1. Increase physical activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Phase II: Healthy Bodies, Hearts After Menopause

Acronym: HBHH

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 6, 2010
Registry last updated
May 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.