Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

July 25, 2024 updated by: University of North Carolina, Chapel Hill

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas: Pilot Study of a Multi-Component Intervention

The goal of this study is to pilot test a 12-week behavioral intervention among perimenopausal Latinas (age 40-55 years) that integrates evidence-based education with physical activity, stress management, and coping skills training to: 1) reduce cardiovascular disease (CVD) risk factors and arterial stiffness; 2) improve nutrition, physical activity, and sleep behaviors; and 3) improve stress management, coping strategies, and self-efficacy. This study will recruit participants from two community groups: one group will be randomly assigned to complete the intervention; the other will be a wait-list control.

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

While CVD mortality is the leading cause of death in the United States, large racial/ethnic disparities in cardiovascular health exist between Latinas and non-Hispanic populations. Risk of CVD increases significantly for women following menopause. There are substantial increases in CVD risk factors during perimenopause, specifically, perimenopausal women exhibit greater visceral adipose tissue, fasting glucose, total cholesterol, and systolic blood pressure, compared to premenopausal women. Although behavioral intervention research targeting CVD risk during perimenopause emerged over the past decade, no studies were designed to decrease biological CVD risk among perimenopausal Latinas. This study will recruit perimenopausal Latinas (age 40-55 years) from two community groups: one group will be randomly assigned to complete the intervention; the other will be a wait-list control. This intervention has 3 phases: 12 weekly sessions (Phase I: education, physical activity, stress management, coping skills training) followed by 3 monthly sessions of continued support (Phase II); and finally 6 months of skill maintenance on their own (Phase III). Data will be collected at Time 1 (0 months [baseline]), Time 2 (6 months [completion of the intervention]) and Time 3 (12 months [after 6 months of maintenance on own]). Data collected will include biological CVD risk factors and arterial stiffness (primary outcomes: blood pressure, lipid profile, blood glucose, carotid-femoral pulse wave velocity). Secondary outcomes will include health behaviors and self-efficacy (Food Behavior Checklist, 7 day Accelerometer, Sleep Quality Scale, Eating Self-Efficacy Scale, Exercise Self-Efficacy Scale) and other biological factors related to CVD risk (waist circumference, weight, body mass index [BMI], C-reactive protein, hair cortisol). The investigators will also evaluate the feasibility of the intervention (e.g., enrollment and retention rates, barriers and facilitators to enrollment, intervention fidelity, suitability of study procedures and outcome measures, and participant satisfaction with the intervention and study protocol). The knowledge to be gained from this pilot study may provide a foundation for extending this intervention to a larger efficacy trial. This research holds potential to accelerate greatly the acquisition of knowledge related to CVD risk among perimenopausal Latinas, and the impact of behavioral interventions to reduce CVD risk in this underserved population.

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.
49

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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 40-60 years
  • self-identify as Hispanic/Latina
  • understand spoken English or Spanish
  • perimenopausal or early postmenopausal (menstrual bleeding in the past 3 months, but timing have varied in past year; no menstrual bleeding in the past 3-11 months; last menstrual cycle 12-24 months ago)
  • intact uterus and at least one ovary
  • not currently pregnant
  • no hormone therapy or oral contraceptives in the past 3 months
  • consent to join the study

Exclusion Criteria:

  • heart murmur
  • congenital heart disease
  • family history of sudden death
  • difficulty exercising
  • history of CVD (heart attack, stroke, coronary heart disease)

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: Triple

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: Education, Physical Activity, and Stress Management Program
Classes for the intervention group will be run by a bilingual interventionist and will last 120 minutes weekly for 12 weeks and then monthly for 3 months.
Behavioral: Education, Physical Activity, and Stress Management Program
Twelve weekly classes for one hour focused on CVD risk factor education using the Su Corazón Su Vida curriculum and coping skills training followed by a 45 minute exercise class and 15 minute stress management session. Then they will return for one hour for continued support, a forty-five minute exercise class, and fifteen minute stress management session.
Active Comparator: Wait-list Control
Data in the wait-list control group will be collected at the same time intervals as the intervention group. After Time 3 data collection, they will be offered the Phase I intervention (12 weekly sessions).
Other: Wait-list
The wait-list control group will receive 12 weekly one hour education and coping skills training sessions followed by a 45 minute exercise class and a 15 minute stress management session.

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
Change in Mean Systolic and Diastolic Blood Pressure (mm/Hg) From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Blood pressure will be measured in the right arm using a digital monitor. Participants will be seated comfortably with feet flat on the floor in a chair with back supported and the right arm resting on a table. The patient should be seated for 3-5 minutes without talking or moving around before recording the first blood pressure reading. Blood pressure will be repeated twice with the average computed. If it is not possible to measure blood pressure in the right arm, the left arm will be used and noted in the participant record.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Mean Systolic and Diastolic Blood Pressure From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Blood pressure will be measured in the right arm using a digital monitor. Participants will be seated comfortably with feet flat on the floor in a chair with back supported and the right arm resting on a table. The patient should be seated for 3-5 minutes without talking or moving around before recording the first blood pressure reading. Blood pressure will be repeated twice with the average computed. If it is not possible to measure blood pressure in the right arm, the left arm will be used and noted in the participant record.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Change in Mean Arterial Stiffness From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Arterial stiffness will be measured by carotid-femoral pulse wave velocity and pulse wave analysis using the Vicorder® System (Skidmore Medical, Bristol, UK). Pulse wave velocity will be repeated twice with the average computed.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Changes in Mean Fasting Lipids (Total Cholesterol) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc™ pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Changes in Mean Fasting Lipids (Triglycerides) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Changes in Mean Fasting Lipids (HDL Cholesterol) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)]
Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)]
Changes in Mean Fasting Lipids (LDL Cholesterol) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
LDL Cholesterol will be computed at Time 1 and Time 3. Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Changes in Mean Fasting Glucose From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Venous blood draw: A certified Research Assistant or Registered Nurse will perform a fasting blood draw. The participant will sit in a stationary chair with their arm of choice placed for the blood draw flat on the table, on top of the BloodBloc pad. The fasting blood sample will be analyzed by using the Cholestech LDX™ System at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 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
Time for Recruitment
Time Frame: Baseline
This will be defined as time (days) from initial contact with research staff to randomization into the study.
Baseline
Change in Mean Weight (Kg) From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Weight will be measured twice using a digital scale placed on a hard, flat surface. The measurement will be recorded to the nearest 0.1-kg.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Mean Weight (Kg) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Weight will be measured twice using a digital scale placed on a hard, flat surface. The measurement will be recorded to the nearest 0.1-kg.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Participant weight and height will be used to calculate BMI. Calculation of BMI in kilograms divided by meters squared.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Mean Body Mass Index (BMI) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Participant weight and height will be used to calculate BMI. Calculation of BMI in kilograms divided by meters squared.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Waist circumference will be measured at the level of the umbilicus in centimeters using a measuring tape.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Mean Adiposity (Waist Circumference) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Waist circumference will be measured at the level of the umbilicus in centimeters using a measuring tape.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in proportion of participants meeting American Heart Association-recommended intake of each of the following: fruits, vegetables, and fish based on completing the Food Behavior Checklist. The Food Behavior Checklist asks participants to indicate the number of daily servings consumed for each category..
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Proportion of Participants Meeting Recommended Intake of Fruits, Vegetables and Fish (Food Behavior Checklist) Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Change in proportion of participants meeting American Heart Association-recommended intake of each of the following: fruits, vegetables, and fish based on completing the Food Behavior Checklist. The Food Behavior Checklist asks participants to indicate the number of daily servings consumed for each category.
Baseline (Time 1), Time 3 (6 month after completion of intervention, approximately 12 months)
Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
The participant will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. The proportion of participants across categories will be reported.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Health Behaviors (Accelerometer Measurement for 7 Days) From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
The participant will wear an accelerometer for 7 days total. This information will be uploaded into the computer to provide data on low, moderate, and high intensity physical activity. The proportion of participants across categories will be reported.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
This is a 25-item questionnaire asking how much difficulty the participant has with controlling her eating in social situations and every day. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score (0-175). A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Median Eating Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
This is a 25-item questionnaire asking how much difficulty the participant has with controlling her eating in social situations and every day. The range of scores go from 1 to 7 with 1 being no difficulty controlling eating to 4 moderate difficulty controlling eating to 7 the most difficulty controlling eating. The 25 questions are added to produce a total score (0-175). A lower score equals less difficulty controlling eating and a higher score equals more difficulty controlling eating.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
This is a 9-item questionnaire asking how much confidence the participant has doing particular exercises. The range of scores go from 0 to 10 with 0 being she is not confident at all (low self-efficacy) and and 10 being that she is certain she can do it (high self-efficacy). The numbers are summed for a total score (0-90) with higher scores indicating greater exercise self-efficacy.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Mean Exercise Self-Efficacy Questionnaire From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
This is a 9-item questionnaire asking how much confidence the participant has doing particular exercises. The range of scores go from 0 to 10 with 0 being she is not confident at all (low self-efficacy) and and 10 being that she is certain she can do it (high self-efficacy). The numbers are summed for a total score (0-90) with higher scores indicating greater exercise self-efficacy.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) ]
This is a 4-item question questionnaire previously used in studies during the menopause transition. Each question is scored from 0 to 4, with 0 being indicating no difficulty with sleep in the past two weeks and 4 indicating five or more times a week of difficulty sleeping. The numbers are summed for a total score (0-16). A lower number indicates that the participant does not have difficulty sleeping and a higher number means that the participant has a lot of difficulty sleeping.
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months) ]
Change in Mean Sleep Quality Questionnaire From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
This is a 4-item question questionnaire previously used in studies during the menopause transition. Each question is scored from 0 to 4, with 0 being indicating no difficulty with sleep in the past two weeks and 4 indicating five or more times a week of difficulty sleeping. The numbers are summed for a total score (0-16). A lower number indicates that the participant does not have difficulty sleeping and a higher number means that the participant has a lot of difficulty sleeping.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Change in Median High-Sensitivity C-Reactive Protein From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Serum high-sensitivity C-reactive protein levels will by obtained by from a fasting blood sample and at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Change in Mean Hair Cortisol Levels From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Cortisol will be obtained from hair samples and analyzed using a standard laboratory protocol at the Biobehavioral Laboratory in the School of Nursing at the University of North Carolina at Chapel Hill.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Number of Eligible Women That Agree to Participate in the Study
Time Frame: Baseline
This will be defined as a number of women that agree to participate in the study out of the total women screened for the study.
Baseline
Mean Proportion of Group Sessions Participants Attend
Time Frame: Time 2 (Intervention completion, approx. 6 months)
The attendance rate will be defined as the proportion of group sessions the participant attends.The mean proportion of sessions that participants attended out of the total of 15 sessions offered is reported.
Time 2 (Intervention completion, approx. 6 months)
Number of Participants at Post-intervention (Time 2) and Study Completion (Time 3)
Time Frame: Time 2 (Intervention completion, approx. 6 months) and Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
The retention rate will be defined as the percentage of participants remaining in the study at post-intervention and at study completion.
Time 2 (Intervention completion, approx. 6 months) and Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Proportion of Participants That Attend at Least 80% of the Intervention Session (12-15 Sessions).
Time Frame: Time 2 (Intervention completion, approx. 6 months)
A Research Assistant will assess fidelity of the intervention fidelity by keeping an attendance log.
Time 2 (Intervention completion, approx. 6 months)
Number of Participants That Would Recommend the Study to a Friend or Relative.
Time Frame: Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Participants will be asked: "If a friend or relative were to be asked to take part in the study, how likely would you be to recommend that they participate?"
Time 3 (after 6 months with no contact from the study staff, approximately 12 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
Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 2
Time Frame: Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks
Baseline (Time 1), Time 2 (Intervention completion, approximately 6 months)
Change in Proportion of Participants Reporting Vasomotor Symptoms From Baseline (Time 1) to Time 3
Time Frame: Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 months)
Participants will report experiencing any vasomotor symptoms (night sweats, hot flashes) in the past two weeks.
Baseline (Time 1), Time 3 (after 6 months with no contact from the study staff, approximately 12 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 North Carolina, Chapel Hill

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.
National Institute on Minority Health and Health Disparities (NIMHD)

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: Yamnia I Cortes, PhD, University of North Carolina, Chapel Hill

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.
June 30, 2020

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.
June 30, 2023

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.
June 30, 2023

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).
March 16, 2020

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.
March 16, 2020

First Posted (Actual)

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.
March 18, 2020

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.
August 20, 2024

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.
July 25, 2024

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.
April 1, 2024

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.
  • 19-2756
  • K23MD014767 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

At the close of the study and after the main data from the study has been published.

IPD Sharing Access Criteria

Contact Dr. Yamnia I. Cortes at yicortes@email.unc.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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