Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial - Full Text View

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:

MedlinePlus related topics: High Blood Pressure Menopause Obesity Weight Control

U.S. FDA Resources

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
Estimated 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).

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

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

National Heart, Lung, and Blood Institute (NHLBI)

More Information

No publications provided

Responsible Party:	Margaret (Molly) Conroy, 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:	April 5, 2010
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
Obesity
Vascular Diseases
Overnutrition

Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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