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

October 1, 2022 updated by: Matthew Allison, University of California, San Diego

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 3 months
Change in blood pressure
3 months
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 months
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.
3 months
Anthropometrics
Time Frame: 3 months
Change in body mass index (BMI)
3 months
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.
3 months
Psychosocial and environmental mediators: self-efficacy
Time Frame: 3 months
Investigators will use measures adapted for our pilot including self-efficacy to sit less.
3 months
Psychosocial and environmental mediators: social support
Time Frame: 3 months
Investigators will use measures adapted for our pilot including social support surrounding sitting less.
3 months
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.
3 months
Psychosocial and environmental mediators: habit formation
Time Frame: 3 months
Assessed using the Self-Report Habit Index
3 months
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.
3 months
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.
3 months
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.
3 months
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.
3 months
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.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3 months
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 months
Epigenetic microRNA biomarkers
Time Frame: 3 months
Measurement of microRNA populations in blood (PBMCs and endothelial cell microparticles) using Hi-Seq
3 months
Vascular environment/endothelial functioning biomarker 1
Time Frame: 3 months
Measurement of plasma biomarkers of systemic inflammation (C-reactive protein (CRP))
3 months
Vascular environment/endothelial functioning biomarker 2
Time Frame: 3 months
Measurement of endothelial cell adhesiveness and activation (vascular adhesion molecule 1 (sVCAM-1))
3 months
Vascular environment/endothelial functioning biomarker 3
Time Frame: 3 months
Measurement of endothelial cell adhesiveness and activation (intercellular adhesion molecule 1 (sICAM-1))
3 months
Vascular environment/endothelial functioning biomarker 4
Time Frame: 3 months
Measurement of endothelial cell adhesiveness and activation (P- and E-selectins)
3 months
Vascular environment/endothelial functioning biomarker 5
Time Frame: 3 months
Measurement of oxidative stress (F2-isoprostane)
3 months
Vascular environment/endothelial functioning biomarker 6
Time Frame: 3 months
Measurement of coagulation (fibrinogen)
3 months
Glucoregulatory and lipid metabolism biomarker 1
Time Frame: 3 months
Measurement of fasting plasma insulin
3 months
Glucoregulatory and lipid metabolism biomarker 2
Time Frame: 3 months
Measurement of glucose
3 months
Glucoregulatory and lipid metabolism biomarker 3
Time Frame: 3 months
Measurement of lipid panel components (total cholesterol, LDL, HDL and triglycerides)
3 months
Glucoregulatory and lipid metabolism biomarker 4
Time Frame: 3 months
Measurement of hemoglobin A1c (HbA1c)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Diego State University
San Ysidro Health Center
South Bay Latino Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthew Allison, MDD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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