Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
- Conditions
- Sedentary Lifestyle
- Interventions
- Device: ActivPAL inclinometerOther: Tools to prompt standing
- Registration Number
- NCT02905929
- Lead Sponsor
- University of California, San Diego
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 254
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitting Less group Tools to prompt standing The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided. Sitting Less group ActivPAL inclinometer The 'reduce sitting' intervention group will receive three in-person health coaching sessions followed by five counseling phone calls. Participants will wear a thigh worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. At each in-person health coaching session participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. In addition to the three initial in-person counseling sessions using the ActivPAL feedback, participants will receive phone calls from the health educator biweekly to help overcome barriers, to work on self-monitoring and planning skills, and to prepare relapse prevention. Tools to help prompt standing, including a standing desk, will also be provided.
- Primary Outcome Measures
Name Time Method Sitting, standing and stepping time 3 months Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL
- Secondary Outcome Measures
Name Time Method Psychosocial and environmental mediators: habit formation 3 months Assessed using the Self-Report Habit Index
Anthropometrics 3 months Change in body mass index (BMI)
Psychosocial and environmental mediators: benefits and barriers 3 months Investigators will use measures adapted for our pilot that include benefits and barriers to sitting less.
Psychosocial and environmental mediators: self-efficacy 3 months Investigators will use measures adapted for our pilot including self-efficacy to sit less.
Demographic moderators: retirement status 3 months Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Demographic moderators: age 3 months Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Demographic moderators: education 3 months Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Blood pressure 3 months Change in blood pressure
Depressive symptoms 3 months Change in depressive symptoms, measured with Center for Epidemiologic Studies Depression (CESD) short form. Scores greater than 10 indicate probable depressive symptoms.
Psychosocial and environmental mediators: home environment support 3 months Investigators will use measures adapted for our pilot including home environment support surrounding sitting less.
Improvement in Quality of Life 3 months Change in quality of life, measured with the EURO-QOL 5-D, a brief 5 item standard scale that has demonstrated validity in populations with diabetes and cardiovascular diseases.
Psychosocial and environmental mediators: social support 3 months Investigators will use measures adapted for our pilot including social support surrounding sitting less.
Demographic moderators: sex 3 months Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Demographic moderators: marital status 3 months Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.
Trial Locations
- Locations (2)
UCSD
🇺🇸San Diego, California, United States
South Bay Latino Research Center
🇺🇸Chula Vista, California, United States