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

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ClinicalTrials.gov Identifier: NCT01439477
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):

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
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 : December 2013
Primary Completion Date : November 2015
Study Completion Date : November 2015
Groups and Cohorts


Outcome Measures

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 ]

Eligibility Criteria

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.
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 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:
exercise
healthy eating
heart disease
prevention & control
Middle aged
Women
Health promotion

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