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| Name | Class |
|---|---|
| South Bay Latino Research Center | UNKNOWN |
| San Ysidro Health Center | OTHER |
| San Diego State University | OTHER |
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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.
Project 2 will address the following aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitting Less group | Experimental | 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. |
|
| Attention Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ActivPAL inclinometer | Device | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial functioning biomarkers | Targeted metabolomic measurement of ~300 plasma metabolites (e.g., amino acids, acylcarnitines, organic acids), primarily associated with mitochondrial biochemical pathways | 3 months |
| Epigenetic DNA modification profile |
Inclusion criteria for RCT (n=250):
Prisoners will not be used for this study.
Exclusion criteria applicable only to the RCT intervention trial participants include:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Allison, MDD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Bay Latino Research Center | Chula Vista | California | 91910 | United States | ||
| UCSD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8037935 | Background | Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84. | |
| Background | Gardiner PA. Understanding and influencing sedentary behaviour in older adults [dissertation]. Vol Doctorate of Philosophy. Brisbane, Australia: University of Queeensland; 2011. | ||
| 16908215 |
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De-identified data will be shared with universities or centers in AHA funded research networks.
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| Phone counseling call: Breaking up sitting time | Behavioral | Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools. |
|
| In-person counseling: Breaking up sitting time | Behavioral | 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. |
|
| Phone counseling call: Healthy living | Behavioral | 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. |
|
| Tools to prompt standing | Other | 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. |
|
| In-person counseling: Healthy living | Behavioral | 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. |
|
| 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 |
Measurement of DNA methylation in peripheral blood monocytes (PBMCs) to determine "bio-age" and Apparent Methylomic Aging Rate (AMAR)
| 3 months |
| Epigenetic microRNA biomarkers | Measurement of microRNA populations in blood (PBMCs and endothelial cell microparticles) using Hi-Seq | 3 months |
| Vascular environment/endothelial functioning biomarker 1 | Measurement of plasma biomarkers of systemic inflammation (C-reactive protein (CRP)) | 3 months |
| Vascular environment/endothelial functioning biomarker 2 | Measurement of endothelial cell adhesiveness and activation (vascular adhesion molecule 1 (sVCAM-1)) | 3 months |
| Vascular environment/endothelial functioning biomarker 3 | Measurement of endothelial cell adhesiveness and activation (intercellular adhesion molecule 1 (sICAM-1)) | 3 months |
| Vascular environment/endothelial functioning biomarker 4 | Measurement of endothelial cell adhesiveness and activation (P- and E-selectins) | 3 months |
| Vascular environment/endothelial functioning biomarker 5 | Measurement of oxidative stress (F2-isoprostane) | 3 months |
| Vascular environment/endothelial functioning biomarker 6 | Measurement of coagulation (fibrinogen) | 3 months |
| Glucoregulatory and lipid metabolism biomarker 1 | Measurement of fasting plasma insulin | 3 months |
| Glucoregulatory and lipid metabolism biomarker 2 | Measurement of glucose | 3 months |
| Glucoregulatory and lipid metabolism biomarker 3 | Measurement of lipid panel components (total cholesterol, LDL, HDL and triglycerides) | 3 months |
| Glucoregulatory and lipid metabolism biomarker 4 | Measurement of hemoglobin A1c (HbA1c) | 3 months |
| San Diego |
| California |
| 92093 |
| United States |
| Background |
| Salmon J, Hume C, Ball K, Booth M, Crawford D. Individual, social and home environment determinants of change in children's television viewing: the Switch-Play intervention. J Sci Med Sport. 2006 Oct;9(5):378-87. doi: 10.1016/j.jsams.2006.06.018. Epub 2006 Aug 14. |
| 16270708 | Background | Norman GJ, Sallis JF, Gaskins R. Comparability and reliability of paper- and computer-based measures of psychosocial constructs for adolescent physical activity and sedentary behaviors. Res Q Exerc Sport. 2005 Sep;76(3):315-23. doi: 10.1080/02701367.2005.10599302. |
| Background | Norman G, Vaughn AA, Roesch S, Sallis JF, Calfas K, Patrick K. Development of decisional balance and self-efficacy measures for adolescent sedentary behaviors. Psychology and Health 2004;19:561-575. |
| 3432232 | Background | Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3. |
| 20181057 | Background | Rosenberg DE, Sallis JF, Kerr J, Maher J, Norman GJ, Durant N, Harris SK, Saelens BE. Brief scales to assess physical activity and sedentary equipment in the home. Int J Behav Nutr Phys Act. 2010 Jan 31;7:10. doi: 10.1186/1479-5868-7-10. |
| 30771560 | Derived | Takemoto M, Schechtman M, Villa N, Talavera G, Sears DD, Natarajan L, Owen N, Rosenberg DE, Dunstan D, Allison M, Kerr J. Arriba por la Vida Estudio (AVE): Study protocol for a standing intervention targeting postmenopausal Latinas. Contemp Clin Trials. 2019 Apr;79:66-72. doi: 10.1016/j.cct.2019.02.004. Epub 2019 Feb 13. |
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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