StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women

Completed

• Conditions: Overweight and Obesity; Cardiovascular Diseases

• Registration Number: NCT01439477
• Lead Sponsor: Tufts University

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death for women in the United States. CVD disproportionately affects underserved populations, specifically low-income, minority, and rural women who have higher obesity rates and experience other health disparities. There is a need for replicable, evidence-based programs that target women, particularly midlife and older women who represent an increasing proportion of the U.S. population, to reduce their CVD risk . StrongWomen - Healthy Hearts is a 12-week, community-based program that has demonstrated effectiveness at improving CVD risk factors, including body weight, diet quality, and physical activity in a controlled, randomized trial conducted with midlife and older overweight and obese subjects in Arkansas and Kansas.

The central objective is to rigorously evaluate dissemination of the StrongWomen - Healthy Hearts Program using the RE-AIM framework to achieve maximal public health impact. Expanded dissemination will occur through the Cooperative State Research, Education and Extension Service (CSREES) This partnership will leverage a long and successful collaboration between Tufts University and CSREES that provides strength training programs to older women in 41 states.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Study Start: 2013-12
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 763

Inclusion Criteria

• Greater than 40 years of age
• Female
• BMI greater than 24
• sedentary (not doing any type of exercise more than once per week)

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Exclusion Criteria

• unstable medical condition that would preclude participation in an exercise program
• current participation in another lifestyle modification program
• cognitive impairment
• pregnancy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Weight	9/2014-7/2015

Secondary Outcome Measures

Name	Time	Method
Cardiorespiratory Fitness (1-Mile Walk Test)	9/2014-7/2015
Waist circumference	9/2014-7/2015
Percent Body Fat	9/2014-7/2015
Diet (24-hour recall)	9/2014-7/2015
Perceived Stress	9/2014-7/2015
Perceived Social Support	9/2014-7/2015
Collective Efficacy	9/2014-7/2015
Physical Activity (IPAQ)	9/2014-7/2015
Physical Activity (accelerometer)	9/2014-7/2015
Self-Regulation	9/2014-7/2015
Blood Pressure	9/2014-7/2015
Self-Efficacy	9/2014-7/2015
Civic Engagement	9/2014-7/2015