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

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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Device: ActivPAL inclinometer; Behavioral: Phone counseling call: Breaking up sitting time; Behavioral: In-person counseling: Breaking up sitting time; Other: Tools to prompt standing; Behavioral: Phone counseling call: Healthy living; Behavioral: In-person counseling: Healthy living

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.

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitting Less group; 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; 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.; Behavioral: Phone counseling call: Breaking up sitting time; Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.; Behavioral: In-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.; Other: Tools 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.
Active Comparator: Attention Control; 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; 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.; Behavioral: In-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.

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: San Diego State University; San Ysidro Health Center; South Bay Latino Research Center
• Investigators: Principal Investigator: Matthew Allison, MDD, University of California, San Diego

Publications and helpful links

General Publications

• 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.
• 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.
• Gardiner PA. Understanding and influencing sedentary behaviour in older adults [dissertation]. Vol Doctorate of Philosophy. Brisbane, Australia: University of Queeensland; 2011.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: sedentary behavior; sitting; standing; inclinometer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 160682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data will be shared with universities or centers in AHA funded research networks.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No