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Education, Physical Activity, and Stress Management Program for Cardiovascular Risk

N/A

Waitlist Available

Led By Yamnia I Cortes, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (time 1), time 3 (after 6 months with no contact from the study staff, approximately 12 months)

Awards & highlights

Study Summary

This trial will test a 12-week program to help perimenopausal Latinas reduce their risk of cardiovascular disease by improving nutrition, physical activity, sleep, and stress management.

Eligible Conditions

Cardiovascular Risk
Self-Efficacy
Vascular Stiffness
Physical Activity
Health Behaviors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (time 1), time 3 (6 month after completion of intervention, approximately 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (time 1), time 3 (6 month after completion of intervention, approximately 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (time 1), time 3 (6 month after completion of intervention, approximately 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mean (or Median) Arterial Stiffness from Baseline (Time 1) to Time 3

Change in Mean (or Median) Systolic and Diastolic Blood Pressure (mm/Hg) from Baseline (Time 1) to Time 2

Change in Mean (or Median) Systolic and Diastolic Blood Pressure from Baseline (Time 1) to Time 3

+5 more

Secondary outcome measures

Change in Health Behaviors (Accelerometer Measurement for 7 Days) from Baseline (Time 1) to Time 2

Change in Health Behaviors (Accelerometer Measurement for 7 Days) from Baseline (Time 1) to Time 3

Change in Mean (or Median) Adiposity (Waist Circumference) from Baseline (Time 1) to Time 2

+21 more

Other outcome measures

Change in Vasomotor Symptoms from Baseline (Time 1) to Time 2

Change in Vasomotor Symptoms from Baseline (Time 1) to Time 3

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Education, Physical Activity, and Stress Management ProgramExperimental Treatment1 Intervention

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.

Group II: Wait-list ControlActive Control1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Education, Physical Activity, and Stress Management Program

2020

N/A

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

383 Previous Clinical Trials

1,216,160 Total Patients Enrolled

2 Trials studying Cardiovascular Risk

1,539 Patients Enrolled for Cardiovascular Risk

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,931 Total Patients Enrolled

5 Trials studying Cardiovascular Risk

1,291 Patients Enrolled for Cardiovascular Risk

Yamnia I Cortes, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this scientific experiment?

"According to clinicaltrials.gov, this medical research project has finished recruiting candidates as of July 28th 2022. It was initially posted on June 30th 2020 and is no longer accepting applicants at this time. However, there are 709 other studies actively searching for participants right now."

Answered by AI

Does this medical experiment permit the participation of participants under 25 years of age?

"This clinical trial seeks patients aged between 40 to 60. Patients that are under 18 and over 65 can find 98 and 579 trials, respectively, best suited for their age group."

Answered by AI

Do I qualify to take part in this investigation?

"This trial is open to 51 individuals who fit the following criteria: aged between 40 and 60, identify as Hispanic/Latina, comprehend either English or Spanish orally, perimenopausal or in early postmenopause (menses within past 3 months but irregular; no menses in last 3-11 months; last menstrual cycle 12-24 months ago), possess a uterus and at least one ovary, not expecting a child currently, abstained from hormone therapy of oral contraceptives for three prior months. Additionally they must provide consent before joining the study."

Answered by AI

What goals are researchers seeking to accomplish with this research endeavor?

"This medical trial is seeking to measure the effect of its intervention on fasting lipids (LDL cholesterol) between baseline assessment and six months after treatment completion. Secondary objectives include changes in weight and BMI, as well as a comparison of health behaviors based on responses to a 16-item food behavior checklist."

Answered by AI

Recent research and studies

Pilot and Feasibility StudiesJournal

A Multi-component, Community-engaged Intervention to Reduce Cardiovascular Disease Risk in Perimenopausal Latinas: Pilot Study Protocol

Cortés, Yamnia I., Diane C. Berry, Krista M. Perreira, Alison Stuebe, Lee Stoner, Cheryl Woods Giscombé, Jamie Crandell, Lymarí Santíago, Latesha K. Harris, and Mayra Duran. 2021. “A Multi-component, Community-engaged Intervention to Reduce Cardiovascular Disease Risk in Perimenopausal Latinas: Pilot Study Protocol”. Pilot and Feasibility Studies. Springer Science and Business Media LLC. doi:10.1186/s40814-020-00756-1.

MenopauseJournal

Lessons Learned in Clinical Research Recruitment of Midlife Latinas During COVID-19

Cortés, Yamnia I., Mayra Duran, Valentina Marginean, Latesha K. Harris, Andrea Cazales, Lymari Santiago, Margarita Diaz Mislan, and Krista M. Perreira. 2022. “Lessons Learned in Clinical Research Recruitment of Midlife Latinas During COVID-19”. Menopause. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/gme.0000000000001983.

clinicaltrials.govStudy

Reducing Cardiovascular Disease Risk in Perimenopausal Latinas

2020. "Reducing Cardiovascular Disease Risk in Perimenopausal Latinas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04313751.