Reducing Cardiovascular Disease Risk in Perimenopausal Latinas
Condition: Cardiovascular Risk Factor; Health Behavior; Physical Activity; Self Efficacy; Vascular Stiffness
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Education, Physical Activity, and Stress Management Program; Wait-list
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hispanic/Latina; Menopause; Cardiovascular disease