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Mind Your Heart Intervention for American Indian Women (MYH)

2026년 6월 22일 업데이트: University of North Carolina, Chapel Hill

MIND Your Heart Study for American Indian Women

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

70

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • North Carolina
      • Pembroke, North Carolina, 미국, 28372
        • 모병
        • UNC Health Primary and Specialty Care at Pembroke
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention Group
Intervention Group: 8-week culturally-adapted intervention
행동: Culturally-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
간섭 없음: Regular Care
Control Group: receives no intervention during the study

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Blood pressure
기간: 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.
Baseline, Week 8, and Month 3
Change in Heart rate variability (HRV)
기간: 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.
Baseline and Month 3
Change in Hs-CRP
기간: Baseline and Month 3
Collection of high-sensitivity C-reactive protein (Hs-CRP) to measure inflammation.
Baseline and Month 3
Change in Interleukin-6 (IL-6)
기간: Baseline and Month 3
Collection of IL-6 to measure inflammation.
Baseline and Month 3
Change in Hemoglobin A1c
기간: Baseline and Month 3
Collection of hemoglobin A1c to measure metabolic function.
Baseline and Month 3
Change in Lipid panel
기간: 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.
Baseline and Month 3
Change in body mass index (BMI)
기간: 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).
Baseline, Week 8, and Month 3
Change in body fat percentage
기간: Baseline, Week 8, and Month 3
Collection of body fat measurements using a handheld bioelectrical impedance device.
Baseline, Week 8, and Month 3

2차 결과 측정

결과 측정
측정값 설명
기간
Change in contextualized stress: burden
기간: 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.
Baseline, Week 8, and Month 3
Change in perceived stress
기간: 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.
Baseline, Week 8, and Month 3
Change in positive psychological well-being
기간: 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.
Baseline, Week 8, and Month 3
Change in positive emotions
기간: 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.
Baseline, Week 8, and Month 3
Change in negative emotions
기간: 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.
Baseline, Week 8, and Month 3
Change in carotenoid concentration
기간: 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.
Baseline, Week 8, and Month 3
Change in physical activity
기간: 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.
Baseline, Week 8, and Month 3
Change in mindfulness self-regulation
기간: 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.
Baseline, Week 8, and Month 3
Change in eating self-efficacy
기간: 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.
Baseline, Week 8, and Month 3
Change in exercise self-efficacy
기간: 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.
Baseline, Week 8, and Month 3
Change in contextualized stress: stress states
기간: 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.
Baseline, Week 8, and Month 3
Change in Super Woman Schema (SWS)
기간: 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.
Baseline, Week 8, and Month 3

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of North Carolina, Chapel Hill

협력자

National Heart, Lung, and Blood Institute (NHLBI)

수사관

  • 수석 연구원: Jada Brooks, University of North Carolina, Chapel Hill

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 7일

기본 완료 (추정된)

2026년 7월 1일

연구 완료 (추정된)

2026년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 22일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 21-1762
  • 5R34HL158947-03 (미국 NIH 보조금/계약)
  • 5R34HL158947-02 (미국 NIH 보조금/계약)
  • 1R34HL158947-01 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

beginning 9 and continuing for 24 months

IPD 공유 액세스 기준

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다