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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34HL158947-03 | U.S. NIH Grant/Contract | View source | |
| 5R34HL158947-02 | U.S. NIH Grant/Contract | View source | |
| 1R34HL158947-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
Participants will:
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:
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Intervention Group: 8-week culturally-adapted intervention |
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| Regular Care | No Intervention | Control Group: receives no intervention during the study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally-adapted intervention to improve cardiovascular health in American Indian women | Behavioral | A culturally-adapted cardiovascular health promotion intervention delivered for 8-weeks with American Indian women at risk for cardiovascular disease |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 8, and Month 3 |
| 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. | Baseline and Month 3 |
| Change in Hs-CRP | Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation. | Baseline and Month 3 |
| Change in Interleukin-6 (IL-6) | Collection of IL-6 to measure inflammation. | Baseline and Month 3 |
| Change in Hemoglobin A1c | Collection of hemoglobin A1c to measure metabolic function. | Baseline and Month 3 |
| Change in Lipid panel | Collection of a fasting lipid panel to measure total cholesterol, high-density lipoprotein, triglycerides, and low-density lipoprotein to measure metabolic function. | Baseline and Month 3 |
| Change in body mass index (BMI) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Women 18-55 years old who self-identify as Lumbee Indian and
Have one or more risk factors for cardiovascular disease:
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:
cisgender women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jada Brooks | Contact | 919-966-4260 | jada@email.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jada Brooks | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Health Primary and Specialty Care at Pembroke | Recruiting | Pembroke | North Carolina | 28372 | United States |
Deidentified individual data that supports the results will be shared beginning 9 and continuing for 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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beginning 9 and continuing for 24 months
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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Research assistants collecting research data
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| Baseline, Week 8, and Month 3 |
| Change in body fat percentage | Collection of body fat measurements using a handheld bioelectrical impedance device. | Baseline, Week 8, and Month 3 |
| Baseline, Week 8, and Month 3 |
| 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. | Baseline, Week 8, and Month 3 |
| 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. | Baseline, Week 8, and Month 3 |
| 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. | Baseline, Week 8, and Month 3 |
| Change in negative 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 negative subscale indicate more negative emotions. | Baseline, Week 8, and Month 3 |
| Change in carotenoid concentration | 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. | Baseline, Week 8, and Month 3 |
| Change in physical activity | 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. | Baseline, Week 8, and Month 3 |
| Change in mindfulness self-regulation | 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. | Baseline, Week 8, and Month 3 |
| Change in eating self-efficacy | 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. | Baseline, Week 8, and Month 3 |
| Change in exercise self-efficacy | 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. | Baseline, Week 8, and Month 3 |
| Change in contextualized stress: stress states | 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. | Baseline, Week 8, and Month 3 |
| Change in Super Woman Schema (SWS) | 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. | Baseline, Week 8, and Month 3 |