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Completed

NCT Number: NCT02905929

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.

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Key information

Conditions

Sedentary Lifestyle Behavior Sedentary Behavior

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

South Bay Latino Research Center, Chula Vista, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Sitting, standing and stepping time

    Time frame: 3 months

    Change in daily time spent sitting, standing and stepping during waking hours as measured objectively by the ActivPAL

Secondary outcomes

  1. Blood pressure

    Time frame: 3 months

    Change in blood pressure

  2. Depressive symptoms

    Time frame: 3 months

    Change in depressive symptoms, measured with Center for Epidemiologic Studies Depression (CESD) short form. Scores greater than 10 indicate probable depressive symptoms.

  3. Improvement in Quality of Life

    Time frame: 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.

  4. Anthropometrics

    Time frame: 3 months

    Change in body mass index (BMI)

  5. Psychosocial and environmental mediators: benefits and barriers

    Time frame: 3 months

    Investigators will use measures adapted for our pilot that include benefits and barriers to sitting less.

  6. Psychosocial and environmental mediators: self-efficacy

    Time frame: 3 months

    Investigators will use measures adapted for our pilot including self-efficacy to sit less.

  7. Psychosocial and environmental mediators: social support

    Time frame: 3 months

    Investigators will use measures adapted for our pilot including social support surrounding sitting less.

  8. Psychosocial and environmental mediators: home environment support

    Time frame: 3 months

    Investigators will use measures adapted for our pilot including home environment support surrounding sitting less.

  9. Psychosocial and environmental mediators: habit formation

    Time frame: 3 months

    Assessed using the Self-Report Habit Index

  10. Demographic moderators: age

    Time frame: 3 months

    Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.

  11. Demographic moderators: sex

    Time frame: 3 months

    Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.

  12. Demographic moderators: education

    Time frame: 3 months

    Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.

  13. Demographic moderators: marital status

    Time frame: 3 months

    Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.

  14. Demographic moderators: retirement status

    Time frame: 3 months

    Self-reported items on the baseline survey. Some of these demographic variables will also be considered covariates in analyses.

Other outcomes

  1. Mitochondrial functioning biomarkers

    Time frame: 3 months

    Targeted metabolomic measurement of ~300 plasma metabolites (e.g., amino acids, acylcarnitines, organic acids), primarily associated with mitochondrial biochemical pathways

  2. Epigenetic DNA modification profile

    Time frame: 3 months

    Measurement of DNA methylation in peripheral blood monocytes (PBMCs) to determine "bio-age" and Apparent Methylomic Aging Rate (AMAR)

  3. Epigenetic microRNA biomarkers

    Time frame: 3 months

    Measurement of microRNA populations in blood (PBMCs and endothelial cell microparticles) using Hi-Seq

  4. Vascular environment/endothelial functioning biomarker 1

    Time frame: 3 months

    Measurement of plasma biomarkers of systemic inflammation (C-reactive protein (CRP))

  5. Vascular environment/endothelial functioning biomarker 2

    Time frame: 3 months

    Measurement of endothelial cell adhesiveness and activation (vascular adhesion molecule 1 (sVCAM-1))

  6. Vascular environment/endothelial functioning biomarker 3

    Time frame: 3 months

    Measurement of endothelial cell adhesiveness and activation (intercellular adhesion molecule 1 (sICAM-1))

  7. Vascular environment/endothelial functioning biomarker 4

    Time frame: 3 months

    Measurement of endothelial cell adhesiveness and activation (P- and E-selectins)

  8. Vascular environment/endothelial functioning biomarker 5

    Time frame: 3 months

    Measurement of oxidative stress (F2-isoprostane)

  9. Vascular environment/endothelial functioning biomarker 6

    Time frame: 3 months

    Measurement of coagulation (fibrinogen)

  10. Glucoregulatory and lipid metabolism biomarker 1

    Time frame: 3 months

    Measurement of fasting plasma insulin

  11. Glucoregulatory and lipid metabolism biomarker 2

    Time frame: 3 months

    Measurement of glucose

  12. Glucoregulatory and lipid metabolism biomarker 3

    Time frame: 3 months

    Measurement of lipid panel components (total cholesterol, LDL, HDL and triglycerides)

  13. Glucoregulatory and lipid metabolism biomarker 4

    Time frame: 3 months

    Measurement of hemoglobin A1c (HbA1c)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Diego State University
  • San Ysidro Health Center
  • South Bay Latino Research Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Sep 19, 2016
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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