Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

a study on Sedentary Lifestyle

Summary

for females ages 55 years and up (full criteria)
healthy people welcome
at San Diego, California and other locations
study started
estimated completion:
Jacqueline Kerr

Description

Summary

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.

Official Title

Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

Details

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.

Keywords

Sedentary Lifestyle sedentary behavior standing sitting inclinometer Heart Diseases ActivPAL inclinometer Phone counseling call: Breaking up sitting time In-person counseling: Breaking up sitting time Phone counseling call: Healthy living Tools to prompt standing In-person counseling: Healthy living

Eligibility

You can join if…

Open to females ages 55 years and up

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.

You CAN'T join if...

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

Locations

  • UCSD accepting new patients
    San Diego California 92093 United States
  • South Bay Latino Research Center accepting new patients
    Chula Vista California 91910 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02905929
Lead Scientist
Jacqueline Kerr
Study Type
Interventional
Last Updated
April 17, 2018