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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439477
First Posted: September 23, 2011
Last Update Posted: November 18, 2015
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.
Information provided by (Responsible Party):
Sara C. Folta, Tufts University
  Purpose

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
Cardiovascular Diseases Overweight and Obesity

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women

Further study details as provided by Sara C. Folta, Tufts University:

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

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

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

Enrollment: 763
Study Start Date: December 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Sara C. Folta, Assistant Professor, Tufts University
ClinicalTrials.gov Identifier: NCT01439477     History of Changes
Other Study ID Numbers: TuftsU-9289
First Submitted: September 21, 2011
First Posted: September 23, 2011
Last Update Posted: November 18, 2015
Last Verified: November 2015

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

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