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

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT01439477

Collaborator

(none)

763

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Overweight and Obesity

Study Design

Study Type:

Observational

Actual Enrollment :

763 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Outcome Measures

Primary Outcome Measures

Body Weight [9/2014-7/2015]

Secondary Outcome Measures

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

Other Outcome Measures

Adherence [9/2014-7/2015]
Retention [9/2014-7/2015]
Satisfaction with Intervention [4/2014-7/2015]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.