Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

Obesity Clinical Trial

— HBHH  

Official title:

Phase II: Healthy Bodies, Hearts After Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099007
• Other study ID #: HL085405
• Secondary ID: 5K23HL085405-03
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2010
• Last updated: May 20, 2014
• Start date: June 2009
• Est. completion date: February 2011

Study information

• Verified date: May 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• High Blood Pressure
• Hypertension
• Obesity

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
United States	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	The goal of the intervention is for participants to have a 10% reduction in body weight	6 months	No
Secondary	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	No