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Trial record 9 of 184 for:    (hispanic OR latina) AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT02905929
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
South Bay Latino Research Center
San Ysidro Health Center
San Diego State University
Information provided by (Responsible Party):
Jacqueline Kerr, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle 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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Control Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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. 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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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 and less than 8000 steps/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. ≥8000 steps/day average, as measured by ActivPAL
  8. Participating in another clinical trial related to study outcomes (as determined by the PI).
  9. Unable to wear devices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905929


Contacts
Contact: Nicole Villa, MPH 619-205-1931 nvilla@mail.sdsu.edu
Contact: Jacqueline Kerr, PhD 858-534-9305 jkerr@ucsd.edu

Locations
United States, California
South Bay Latino Research Center Recruiting
Chula Vista, California, United States, 91910
Contact: Nicole Villa, MPH    619-205-1931    nvilla@mail.sdsu.edu   
UCSD Recruiting
San Diego, California, United States, 92093
Contact: Katie Crist, MPH    858-534-9306    kcrist@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
South Bay Latino Research Center
San Ysidro Health Center
San Diego State University
Investigators
Principal Investigator: Jacqueline Kerr, PhD University of California, San Diego

Publications:
Responsible Party: Jacqueline Kerr, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02905929     History of Changes
Other Study ID Numbers: 160682
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with universities or centers in AHA funded research networks.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacqueline Kerr, University of California, San Diego:
sedentary behavior
standing
sitting
inclinometer

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases