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OpenTrials
Completed

NCT Number: NCT01439477

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Body Weight

    Time frame: 9/2014-7/2015

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2011
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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