Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 4/21/2018 |
| Start Date: | April 1, 2017 |
| End Date: | March 2020 |
| Contact: | Nicole Villa, MPH |
| Email: | nvilla@mail.sdsu.edu |
| Phone: | 619-205-1931 |
Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA)
Women's Health Program will assess 3-month changes in sitting time, standing time, physical
activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in
the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting
and have increased risk for cardiovascular disease through high BMI and other cardiometabolic
risk factors. Women will be identified through the San Ysidro Health Center and assessed at
the South Bay Latino Research Center.
Women's Health Program will assess 3-month changes in sitting time, standing time, physical
activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in
the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting
and have increased risk for cardiovascular disease through high BMI and other cardiometabolic
risk factors. Women will be identified through the San Ysidro Health Center and assessed at
the South Bay Latino Research Center.
Project 2 will address the following aims:
1. Investigate the 3 month effect of the intervention to impact the primary behavioral
outcomes of sitting, standing and stepping time assessed objectively by a thigh worn
inclinometer (ActivPAL) in Latinas at risk for heart disease.
2. Investigate the 3 month effect of the intervention to impact the secondary health
outcomes of blood pressure, depressive symptoms, and anthropometrics.
3. Explore the psychosocial & environmental mediators & moderators of changes in sitting
time.
1. Investigate the 3 month effect of the intervention to impact the primary behavioral
outcomes of sitting, standing and stepping time assessed objectively by a thigh worn
inclinometer (ActivPAL) in Latinas at risk for heart disease.
2. Investigate the 3 month effect of the intervention to impact the secondary health
outcomes of blood pressure, depressive symptoms, and anthropometrics.
3. Explore the psychosocial & environmental mediators & moderators of changes in sitting
time.
Inclusion criteria for RCT (n=250):
1. Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.
2. Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,
3. Ambulatory, medically stable, able to give informed consent, and safely complete the
protocols.
4. Body Mass Index range of 25.0-45.0kg/m2.
5. Sedentary: Average >8 hours sitting/day and less than 8000 steps/day, as measured by
ActivPAL on 4+ days per week
6. Phone access (to receive counseling)
Prisoners will not be used for this study.
Exclusion criteria applicable only to the RCT intervention trial participants include:
1. Unable to complete the Short Physical Performance Battery.
2. Mental states that would preclude complete understanding of the protocol and
compliance.
3. Active cancer or another serious chronic illness that may be associated with weight
change
4. Body Mass Index <25.0 or >45.0kg/m2.
5. Use of insulin medications.
6. ≤ 8hr average daily sitting time, as measured by ActivPAL.
7. ≥8000 steps/day average, as measured by ActivPAL
8. Participating in another clinical trial related to study outcomes (as determined by
the PI).
9. Unable to wear devices
We found this trial at
2
sites
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