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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01439477
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Sara C. Folta, 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.

Condition or disease
Cardiovascular Diseases Overweight and Obesity

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 : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Primary Outcome Measures :
  1. Body Weight [ Time Frame: 9/2014-7/2015 ]

Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: 9/2014-7/2015 ]
  2. Percent Body Fat [ Time Frame: 9/2014-7/2015 ]
  3. Diet (24-hour recall) [ Time Frame: 9/2014-7/2015 ]
  4. Physical Activity (IPAQ) [ Time Frame: 9/2014-7/2015 ]
  5. Physical Activity (accelerometer) [ Time Frame: 9/2014-7/2015 ]
  6. Cardiorespiratory Fitness (1-Mile Walk Test) [ Time Frame: 9/2014-7/2015 ]
  7. Blood Pressure [ Time Frame: 9/2014-7/2015 ]
  8. Self-Regulation [ Time Frame: 9/2014-7/2015 ]
  9. Collective Efficacy [ Time Frame: 9/2014-7/2015 ]
  10. Perceived Stress [ Time Frame: 9/2014-7/2015 ]
  11. Self-Efficacy [ Time Frame: 9/2014-7/2015 ]
  12. Perceived Social Support [ Time Frame: 9/2014-7/2015 ]
  13. Civic Engagement [ Time Frame: 9/2014-7/2015 ]

Other Outcome Measures:
  1. Adherence [ Time Frame: 9/2014-7/2015 ]
  2. Retention [ Time Frame: 9/2014-7/2015 ]
  3. Satisfaction with Intervention [ Time Frame: 4/2014-7/2015 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women greater than 40 years old who are overweight or obese and sedentary

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.

Responsible Party: Sara C. Folta, Assistant Professor, Tufts University Identifier: NCT01439477     History of Changes
Other Study ID Numbers: TuftsU-9289
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Sara C. Folta, Tufts University:
healthy eating
heart disease
prevention & control
Middle aged
Health promotion

Additional relevant MeSH terms:
Cardiovascular Diseases
Body Weight
Signs and Symptoms