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CompletedNCT01439477Updated Apr 12, 2024

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

An observational study in Cardiovascular Diseases and Overweight and Obesity, sponsored by Tufts University. Completed. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Tufts University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
763
Ages
40 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Cardiovascular Diseases
  • Overweight and Obesity

Keywords

  • exercise
  • healthy eating
  • heart disease
  • prevention & control
  • Middle aged
  • Women
  • Health promotion
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In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 763 is above the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Tufts University is the lead sponsor of 228 studies on the registry; 25 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • unstable medical condition that would preclude participation in an exercise program
  • current participation in another lifestyle modification program
  • cognitive impairment
  • pregnancy.
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
763 participants (actual)
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What researchers measure

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01439477
Lead sponsor
Tufts University
Responsible party
Sara C. Folta (Assistant Professor, Tufts University) — Principal investigator
First posted
Sep 23, 2011
Start date
Dec 2013
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Apr 12, 2024

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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