Cardiovascular DiseasesNCT01439477
StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women
An observational study of Cardiovascular Diseases and Overweight and Obesity, run by Tufts University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Overweight and Obesity
- How many people
- 763 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women greater than 40 years old who are overweight or obese and sedentary
Who may be able to join
- Greater than 40 years of age
- Female
- BMI greater than 24
- sedentary (not doing any type of exercise more than once per week)
Who cannot join
- unstable medical condition that would preclude participation in an exercise program
- current participation in another lifestyle modification program
- cognitive impairment
- pregnancy.
About this study
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.
- Conditions
- Cardiovascular Diseases, Overweight and Obesity
- Keywords
- exercise, healthy eating, heart disease, prevention & control, Middle aged, Women, Health promotion
- Medical subject headings
- Cardiovascular Diseases, Overweight, Obesity, Motor Activity, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 9/2014-7/2015
Secondary outcomes (13)
Waist circumference
Measured: 9/2014-7/2015
Percent Body Fat
Measured: 9/2014-7/2015
Diet (24-hour recall)
Measured: 9/2014-7/2015
Physical Activity (IPAQ)
Measured: 9/2014-7/2015
Physical Activity (accelerometer)
Measured: 9/2014-7/2015
Cardiorespiratory Fitness (1-Mile Walk Test)
Measured: 9/2014-7/2015
Blood Pressure
Measured: 9/2014-7/2015
Self-Regulation
Measured: 9/2014-7/2015
Collective Efficacy
Measured: 9/2014-7/2015
Perceived Stress
Measured: 9/2014-7/2015
Self-Efficacy
Measured: 9/2014-7/2015
Perceived Social Support
Measured: 9/2014-7/2015
Civic Engagement
Measured: 9/2014-7/2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara C. Folta, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439477
- Sponsor's protocol ID
- TuftsU-9289
- Status last verified
- Apr 2024
- First submitted
- 21 Sep 2011
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women
- ClinicalTrials.gov ID
- NCT01439477
- Acronym / sponsor ID
- TuftsU-9289
- Conditions
- Cardiovascular Diseases, Overweight and Obesity
- Keywords
- exercise, healthy eating, heart disease, prevention & control, Middle aged, Women, Health promotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women greater than 40 years old who are overweight or obese and sedentary
Key inclusion criteria (4 listed)
- Greater than 40 years of age
- Female
- BMI greater than 24
- sedentary (not doing any type of exercise more than once per week)
Key exclusion criteria (4 listed)
- unstable medical condition that would preclude participation in an exercise program
- current participation in another lifestyle modification program
- cognitive impairment
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Weight
Time frame: 9/2014-7/2015
13 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Overweight and Obesity, run by Tufts University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 9/2014-7/2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.