Mind Your Heart Intervention for American Indian Women
ConditionCardiovascular Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The goal of this clinical trial is to learn if a culturally-adapted intervention can improve cardiovascular health in American Indian women.
The main questions it aims to answer are:
* Can this intervention realistically work for American Indian women? * Do American Indian women find the intervention acceptable? * Does the intervention help improve cardiovascular health in American Indian women? Researchers will compare the intervention group to a control group (a group that does not receive the intervention) to see whether the cardiovascular health of the intervention group improves.
Participants will:
* Attend 3 data collections over 3 months. * Be randomly assigned to either the intervention group or a control group. * (Intervention group participants) attend 8 weekly classes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women 18-55 years old who self-identify as Lumbee Indian and
overweight/obese, defined as BMI >25 kg/m²
hypertensive as measured by study staff
physical inactivity
Disqualifiers
Women currently enrolled in an organized weight-loss or mindfulness program
Pregnant women or women planning to become pregnant during the study period
heart murmur
congenital heart disease
Trial design
Design model
Parallel
Treatments tested in this trial
Culturally-adapted intervention to improve cardiovascular health in American Indian women
BehavioralA culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Regular CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Blood pressure
Blood pressure will be measured three times during each appointment. The first blood pressure will be discarded, and the second and third measures will be averaged. Participants will rest 1 to 2 minutes between each reading.
Time frame
Baseline, Week 8, and Month 32
Change in Heart rate variability (HRV)
HRV will be measured using a dual wireless electrocardiogram portable device for 10 minutes while the participant is resting in a seated position.
Time frame
Baseline and Month 33
Change in Hs-CRP
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
Time frame
Baseline and Month 34
Change in Interleukin-6 (IL-6)
Collection of IL-6 to measure inflammation.
Time frame
Baseline and Month 3Secondary outcomes
1
Change in contextualized stress: burden
The investigators will measure burden (as a subscale of contextualized stress) using the Jackson, Hogue, Phillips (JHP) Contextualized Stress Measure (Gendered and Financial Stress) Burden Subscale. 17-item subscale of the JHP Contextualized Stress measure assessing chronic exposure to gendered and racialized stress. The burden subscale uses a 6-point Likert scale (1=Strongly Agree to 5=Strongly Disagree; 6=Not Applicable). Scores range from 17-102 with higher scores reflect a better outcome.
Time frame
Baseline, Week 8, and Month 32
Change in perceived stress
Perceived stress will be measured using the Perceived Stress Scale (PSS), a 10-item scale assessing stress experiences over the preceding month. The PSS measures the frequency of feelings and thoughts using a 5-point Likert scale, where positive responses are scored in reverse. The PSS score is determined by totaling all responses and ranges from 0 to 40 with lower scores reflecting a better outcome.
Time frame
Baseline, Week 8, and Month 33
Change in positive psychological well-being
Mental Health Continuum - Short Form (MHC-SF) measures positive emotions and comprises 14 items, representing emotional well-being, psychosocial well-being, and social well-being. On a 6-point Likert scale (0 = never; 5 = everyday), respondents indicate how often they felt various positive feelings in the past month and the extent of their agreement or disagreement with various statements indicative of psychosocial and social well-being. Possible scores for the MHC-SF range from 0 - 70. Higher scores reflect a better outcome.
Time frame
Baseline, Week 8, and Month 34
Change in positive emotions
The Modified Differential Emotions Scale (mDES) will be used to capture a broader array of emotions. Respondents rate the frequency of their experiences of 20 different emotions over the past two weeks, using a 5-point scale (0 = not at all; 4 = most of the time). Items are summed for both positive and negative emotions (both ranging from 0 - 40). Higher scores on the positive subscale indicate more positive emotions.
Time frame
Baseline, Week 8, and Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov