Sedentary Lifestyle
Conditions
Keywords
sedentary behavior, standing, sitting, inclinometer
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.
Interventions
DEVICEActivPAL inclinometer
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.
BEHAVIORALPhone counseling call: Breaking up sitting time
Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
BEHAVIORALIn-person counseling: Breaking up sitting time
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.
BEHAVIORALPhone counseling call: Healthy living
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.
OTHERTools to prompt standing
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.
BEHAVIORALIn-person counseling: Healthy living
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.
Sponsors
South Bay Latino Research Center
San Ysidro Health Center
San Diego State University
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
Yes
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, 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. Participating in another clinical trial related to study outcomes (as determined by the PI). 8. Unable to wear devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Blood pressure | 3 months | Change in blood pressure |
| 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. |
| 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. |
| Psychosocial and environmental mediators: social support | 3 months | Investigators will use measures adapted for our pilot including social support surrounding sitting less. |
| Psychosocial and environmental mediators: home environment support | 3 months | Investigators will use measures adapted for our pilot including home environment support surrounding sitting less. |
| Psychosocial and environmental mediators: habit formation | 3 months | Assessed using the Self-Report Habit Index |
| 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: sex | 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Epigenetic microRNA biomarkers | 3 months | Measurement of microRNA populations in blood (PBMCs and endothelial cell microparticles) using Hi-Seq |
| Vascular environment/endothelial functioning biomarker 1 | 3 months | Measurement of plasma biomarkers of systemic inflammation (C-reactive protein (CRP)) |
| Vascular environment/endothelial functioning biomarker 2 | 3 months | Measurement of endothelial cell adhesiveness and activation (vascular adhesion molecule 1 (sVCAM-1)) |
| Vascular environment/endothelial functioning biomarker 3 | 3 months | Measurement of endothelial cell adhesiveness and activation (intercellular adhesion molecule 1 (sICAM-1)) |
| Vascular environment/endothelial functioning biomarker 4 | 3 months | Measurement of endothelial cell adhesiveness and activation (P- and E-selectins) |
| Vascular environment/endothelial functioning biomarker 5 | 3 months | Measurement of oxidative stress (F2-isoprostane) |
| Vascular environment/endothelial functioning biomarker 6 | 3 months | Measurement of coagulation (fibrinogen) |
| Glucoregulatory and lipid metabolism biomarker 1 | 3 months | Measurement of fasting plasma insulin |
| Glucoregulatory and lipid metabolism biomarker 2 | 3 months | Measurement of glucose |
| Glucoregulatory and lipid metabolism biomarker 3 | 3 months | Measurement of lipid panel components (total cholesterol, LDL, HDL and triglycerides) |
| Glucoregulatory and lipid metabolism biomarker 4 | 3 months | Measurement of hemoglobin A1c (HbA1c) |
| Epigenetic DNA modification profile | 3 months | Measurement of DNA methylation in peripheral blood monocytes (PBMCs) to determine bio-age and Apparent Methylomic Aging Rate (AMAR) |
| Mitochondrial functioning biomarkers | 3 months | Targeted metabolomic measurement of \ 300 plasma metabolites (e.g., amino acids, acylcarnitines, organic acids), primarily associated with mitochondrial biochemical pathways |
Countries
United States
Outcome results
None listed