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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01099007
First received: April 2, 2010
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Cardiovascular Disease
High Blood Pressure
Behavioral: In Person
Behavioral: At Home
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II: Healthy Bodies, Hearts After Menopause

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The goal of the intervention is for participants to have a 10% reduction in body weight


Secondary Outcome Measures:
  • Increase physical activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 99
Study Start Date: June 2009
Study Completion Date: February 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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.
Experimental: 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).
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).

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099007

Locations
United States, Pennsylvania
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01099007     History of Changes
Other Study ID Numbers: HL085405, 5K23HL085405-03
Study First Received: April 2, 2010
Last Updated: May 20, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Women
Menopause
Cardiovascular Disease
Physical Activity
Weight Loss

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014