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

Study Overview
=================
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: 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. Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics. Explore the psychosocial & environmental mediators & moderators of changes in sitting time.

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

Conditions
-----------------
Sedentary Lifestyle

Intervention / Treatment
-----------------
* Device: ActivPAL inclinometer
* Behavioral: Phone counseling call: Breaking up sitting time
* Behavioral: In-person counseling: Breaking up sitting time
* Behavioral: Phone counseling call: Healthy living
* Other: Tools to prompt standing
* Behavioral: In-person counseling: Healthy living


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for RCT (n=250): Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age. Self-identify as Hispanic ethnicity, able to read and write in English or Spanish, Ambulatory, medically stable, able to give informed consent, and safely complete the protocols. Body Mass Index range of 25.0-45.0kg/m2. Sedentary: Average >8 hours sitting/day, as measured by ActivPAL on 4+ days per week Phone access (to receive counseling) Prisoners will not be used for this study. Exclusion criteria applicable only to the RCT intervention trial participants include: Unable to complete the Short Physical Performance Battery. Mental states that would preclude complete understanding of the protocol and compliance. Active cancer or another serious chronic illness that may be associated with weight change Body Mass Index <25.0 or >45.0kg/m2. Use of insulin medications. ≤ 8hr average daily sitting time, as measured by ActivPAL. Participating in another clinical trial related to study outcomes (as determined by the PI). Unable to wear devices

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitting Less group<br>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. | Device: ActivPAL inclinometer<br>* Participants will wear a thigh-worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. The device will monitor their sitting and standing time.<br>Behavioral: Phone counseling call: Breaking up sitting time<br>* Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.<br>Behavioral: In-person counseling: Breaking up sitting time<br>* Participants will receive 3 in-person health education sessions. At these sessions participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. Participants will also develop action plans, check-in on goal setting, and use of tools at these sessions.<br>Other: Tools to prompt standing<br>* Investigators will provide standing desks to participants who spend time sitting at a computer. Additional tools to help prompt standing are mechanical and electronic timers set to interrupt long periods of sitting and cues in the environment such as standing during commercial breaks and phone calls.<br>|
| Active Comparator: Attention Control<br>Participants in the attention control condition will receive a healthy aging educational intervention developed and tested by the investigators in previous studies. This group will receive one in-person coaching session followed by seven phone coaching sessions. | Behavioral: Phone counseling call: Healthy living<br>* Participants will receive a healthy living educational intervention over the phone, developed and tested by the investigators in previous studies. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.<br>Behavioral: In-person counseling: Healthy living<br>* Control subjects will receive one in-person counseling session about healthy living. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitting, standing and stepping time | Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change in blood pressure | 3 months | 
| Depressive symptoms | Change in depressive symptoms, measured with Center for Epidemiologic Studies Depression (CESD) short form. Scores greater than 10 indicate probable depressive symptoms. | 3 months | 
| Improvement in Quality of Life | 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. | 3 months | 
| Anthropometrics | Change in body mass index (BMI) | 3 months | 
| Psychosocial and environmental mediators: benefits and barriers | Investigators will use measures adapted for our pilot that include benefits and barriers to sitting less. | 3 months | 
| Psychosocial and environmental mediators: self-efficacy | Investigators will use measures adapted for our pilot including self-efficacy to sit less. | 3 months | 
| Psychosocial and environmental mediators: social support | Investigators will use measures adapted for our pilot including social support surrounding sitting less. | 3 months | 
| Psychosocial and environmental mediators: home environment support | Investigators will use measures adapted for our pilot including home environment support surrounding sitting less. | 3 months | 
| Psychosocial and environmental mediators: habit formation | Assessed using the Self-Report Habit Index | 3 months | 
| Demographic moderators: age | Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses. | 3 months | 
| Demographic moderators: sex | Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses. | 3 months | 
| Demographic moderators: education | Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses. | 3 months | 
| Demographic moderators: marital status | Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses. | 3 months | 
| Demographic moderators: retirement status | Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedentary behavior, standing, sitting, inclinometer