Clinical trial NCT01439477: StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women
Official title: StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Overweight and Obesity
Keywords: exercise
healthy eating
heart disease
prevention & control
Middle aged
Women
Health promotion
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 763
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women greater than 40 years old who are overweight or obese and sedentary

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.


Eligibility 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.

Primary outcomes:
measure: Body Weight
timeFrame: 9/2014-7/2015
Secondary outcomes:
measure: Waist circumference
timeFrame: 9/2014-7/2015
measure: Percent Body Fat
timeFrame: 9/2014-7/2015
measure: Diet (24-hour recall)
timeFrame: 9/2014-7/2015
measure: Physical Activity (IPAQ)
timeFrame: 9/2014-7/2015
measure: Physical Activity (accelerometer)
timeFrame: 9/2014-7/2015
measure: Cardiorespiratory Fitness (1-Mile Walk Test)
timeFrame: 9/2014-7/2015
measure: Blood Pressure
timeFrame: 9/2014-7/2015
measure: Self-Regulation
timeFrame: 9/2014-7/2015
measure: Collective Efficacy
timeFrame: 9/2014-7/2015
measure: Perceived Stress
timeFrame: 9/2014-7/2015
measure: Self-Efficacy
timeFrame: 9/2014-7/2015
measure: Perceived Social Support
timeFrame: 9/2014-7/2015
measure: Civic Engagement
timeFrame: 9/2014-7/2015
Other outcomes:
measure: Adherence
timeFrame: 9/2014-7/2015
measure: Retention
timeFrame: 9/2014-7/2015
measure: Satisfaction with Intervention
timeFrame: 4/2014-7/2015
Locations:
Study officials:
References: