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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sara C. Folta, Tufts University
ClinicalTrials.gov Identifier:
NCT01439477
First received: September 21, 2011
Last updated: November 17, 2015
Last verified: November 2015
  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 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

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 
Study First Received: September 21, 2011
Last Updated: November 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 28, 2016