CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Education, Physical Activity, and Stress Management Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04313751
NCT04313751N/ACompleted

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

University of North Carolina, Chapel Hill·interventional·Posted Mar 18, 2020·Updated Aug 20, 2024

In Brief

A clinical study evaluating Education, Physical Activity, and Stress Management Program and Wait-list for Cardiovascular Risk Factor and 4 related conditions. Completed, enrolled 49 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 18, 2020
Enrollment StartJun 30, 2020
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 6.3 years ago

Interventions

Education, Physical Activity, and Stress Management Programbehavioral

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.

Wait-listother

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.