Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial

NCT01099007 | Completed Phase 1

• 2 other identifiers: HL0854055K23HL085405-03
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cardiovascular Disease; High Blood Pressure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Weight loss

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

  6 months

Secondary Outcomes (1)

• Increase physical activity

  3 months

Study Arms (2)

At Home

ACTIVE COMPARATOR

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

In Person

EXPERIMENTAL

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

Interventions

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).

In Person

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.

At Home

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases; Hypertension; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Behavior; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 6, 2010
• Study Start: June 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2011
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)