Cardiovascular Health
Conditions
Brief summary
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.
Detailed description
Conduct a 3-month randomized controlled pilot study to examine feasibility, acceptability, and initial efficacy of an 8-week, culturally-adapted intervention in American Indian women at risk for cardiovascular disease on the following outcomes: Primary cardiovascular health outcomes: * blood pressure * heart rate variability * inflammatory markers * metabolic function Secondary outcomes: * stress * positive psychological well-being * health behaviors (diet, exercise) * self-regulation * self-efficacy
Interventions
BEHAVIORALCulturally-adapted intervention to improve cardiovascular health in American Indian women
A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease
Sponsors
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Research assistants collecting research data
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women 18-55 years old who self-identify as Lumbee Indian and * Have one or more risk factors for cardiovascular disease: * overweight/obese, defined as BMI \>25 kg/m\^2 * hypertensive as measured by study staff * physical inactivity * Willing and able to follow study procedures
Exclusion criteria
* Women currently enrolled in an organized weight-loss or mindfulness program * Pregnant women or women planning to become pregnant during the study period * Conditions that exclude study enrollment include: * heart murmur * congenital heart disease * family history of sudden death * or orthopedic limitations or health conditions precluding exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood pressure | Baseline, Week 8, and Month 3 | 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. |
| Change in Heart rate variability (HRV) | Baseline and Month 3 | HRV will be measured using a dual wireless electrocardiogram portable device for 10 minutes while the participant is resting in a seated position. |
| Change in Hs-CRP | Baseline and Month 3 | Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation. |
| Change in Interleukin-6 (IL-6) | Baseline and Month 3 | Collection of IL-6 to measure inflammation. |
| Change in Hemoglobin A1c | Baseline and Month 3 | Collection of hemoglobin A1c to measure metabolic function. |
| Change in Lipid panel | Baseline and Month 3 | Collection of a fasting lipid panel to measure total cholesterol, high-density lipoprotein, triglycerides, and low-density lipoprotein to measure metabolic function. |
| Change in body mass index (BMI) | Baseline, Week 8, and Month 3 | Collection of weight and height to calculate BMI. Weight and height will be collected two times during each visit and averaged. The average weight and height will be calculated to determine BMI. BMI is calculated as weight (kg) / height (m\^2). |
| Change in body fat percentage | Baseline, Week 8, and Month 3 | Collection of body fat measurements using a handheld bioelectrical impedance device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in contextualized stress: burden | Baseline, Week 8, and Month 3 | 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. |
| Change in perceived stress | Baseline, Week 8, and Month 3 | 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. |
| Change in positive psychological well-being | Baseline, Week 8, and Month 3 | 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. |
| Change in positive emotions | Baseline, Week 8, and Month 3 | 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. |
| Change in negative emotions | Baseline, Week 8, and Month 3 | 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 negative subscale indicate more negative emotions. |
| Change in carotenoid concentration | Baseline, Week 8, and Month 3 | As a proxy for fruit and vegetable (F/V) intake, carotenoid concentrations in the skin will be measured using a portable, non-invasive, pressure-mediated reflection spectroscopy device called the Veggie Meter. The Veggie Meter produces a score from 0 to 800, with higher scores indicating greater skin carotenoid levels, which suggest a greater intake of fruits and vegetables. |
| Change in physical activity | Baseline, Week 8, and Month 3 | Physical activity will be measured by total time being active. Investigators will collect activity data over a 7-day span using an accelerometer worn on the wrist. |
| Change in mindfulness self-regulation | Baseline, Week 8, and Month 3 | Mindfulness self-regulation will be measured using the Five Facet Mindfulness Questionnaire (FFMQ), a 39-item, self-administered measure that assesses various aspects of mindfulness. Responses range from 1 (never/very rarely true) to 5 (almost always/always true) and are summed for a final score. Higher scores indicate greater mindfulness. Total scores range from 39 - 195. |
| Change in eating self-efficacy | Baseline, Week 8, and Month 3 | Eating self-efficacy will be measured using the Eating Self-Efficacy Scale, a 25-item tool asking respondents to rate their difficulty in controlling eating from 1 (no difficulty) to 7 (most difficultly). Scores range from 25 - 175 with higher total scores indicating lower self-efficacy. |
| Change in exercise self-efficacy | Baseline, Week 8, and Month 3 | Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale (SEE), which records the strength of efficacy beliefs by 9 questions on a 11-point scale from 0 (cannot do at all) to 10 (certain can do). Scores range from 0 - 90 with higher scores indicating greater exercise self-efficacy. |
| Change in contextualized stress: stress states | Baseline, Week 8, and Month 3 | The investigators will measure stress states (as a subscale of contextualized stress) using the Jackson, Hogue, Phillips (JHP) Contextualized Stress Measure (Gendered and Financial Stress) Stress States Subscale. 4-item subscale of the JHP Contextualized Stress assessing chronic exposure to gendered and racialized stress. The stress states subscale uses a 6-point Likert scale (1=Strongly Agree to 5=Strongly Disagree; 6=Not Applicable). Higher scores indicate greater stress. |
| Change in Super Woman Schema (SWS) | Baseline, Week 8, and Month 3 | 35-item measures 5 dimensions of internalized strength, emotion suppression, vulnerability resistance, motivation, and caretaking. Items are summed using a Likert scale (0=not true to 4=true all the time). Low SWS = 0-36; Moderate SWS = 36-70; High SWS = 71-105. Higher scores indicate closer alignment to the schema. |
Countries
United States
Contacts
CONTACTJada Brooks
PRINCIPAL_INVESTIGATORJada Brooks
University of North Carolina, Chapel Hill
Outcome results
None listed