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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439477
• Other study ID #: TuftsU-9289
• Status: Completed
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: April 2024
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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)

Exclusion Criteria:

• unstable medical condition that would preclude participation in an exercise program

• current participation in another lifestyle modification program

• cognitive impairment

• pregnancy.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence		9/2014-7/2015
Other	Retention		9/2014-7/2015
Other	Satisfaction with Intervention		4/2014-7/2015
Primary	Body Weight		9/2014-7/2015
Secondary	Waist circumference		9/2014-7/2015
Secondary	Percent Body Fat		9/2014-7/2015
Secondary	Diet (24-hour recall)		9/2014-7/2015
Secondary	Physical Activity (IPAQ)		9/2014-7/2015
Secondary	Physical Activity (accelerometer)		9/2014-7/2015
Secondary	Cardiorespiratory Fitness (1-Mile Walk Test)		9/2014-7/2015
Secondary	Blood Pressure		9/2014-7/2015
Secondary	Self-Regulation		9/2014-7/2015
Secondary	Collective Efficacy		9/2014-7/2015
Secondary	Perceived Stress		9/2014-7/2015
Secondary	Self-Efficacy		9/2014-7/2015
Secondary	Perceived Social Support		9/2014-7/2015
Secondary	Civic Engagement		9/2014-7/2015