grant

Mind Your Heart Intervention for American Indian Women

Organization UNIV OF NORTH CAROLINA CHAPEL HILLLocation CHAPEL HILL, UNITED STATESPosted 20 Aug 2021Deadline 31 Jul 2026
NIHUS FederalResearch GrantFY2023AddressAdult-Onset Diabetes MellitusAgeAge YearsAmerican IndianAmerican IndiansAreaAttentionBlood PressureBuffersCardiac healthCardiovascular DiseasesCategoriesCessation of lifeCharacteristicsClinical TrialsClinical Trials DesignCognitive DiscriminationCommunitiesControl GroupsCoping SkillsDataData CollectionDeathDeath RateDietDiscriminationDisparateElementsEmotional well beingEnrollmentExclusionExerciseFeels wellFoundationsFutureGoalsHealthHealth BenefitHealth Care ProvidersHealth InstructionHealth PersonnelHealth PromotionHealth Promotion and EducationHealth Promotion and InstructionHealth Promotion and TrainingHealth TutoringHealth behaviorHealth educationHealthcare ProvidersHealthcare workerHeartHeart healthHistoryIRBIRBsImpoverishedIndigenousInformal Social ControlInfrastructureInjuryInstitutional Review BoardsInterventionIntervention StrategiesInvestigatorsKetosis-Resistant Diabetes MellitusLength of LifeLifeLongevityManualsMaturity-Onset Diabetes MellitusMetabolicMethodologyMethodsMindModelingNHLBINIDDMNational Heart, Lung, and Blood InstituteNon-Insulin Dependent DiabetesNon-Insulin-Dependent Diabetes MellitusNoninsulin Dependent DiabetesNoninsulin Dependent Diabetes MellitusNormal mental conditionNormal mental stateNormal psycheNorth CarolinaObesityOutcomeOver weightOverweightPTSDPilot ProjectsPost-Traumatic NeurosesPost-Traumatic Stress DisordersPosttraumatic NeurosesPovertyPremature MortalityPreparationProceduresProcessProtocolProtocols documentationPsychological Well BeingPsychosocial FactorPsychosocial StressQOCQuality of CareRaceRacesRandomizedRandomized, Controlled TrialsRecording of previous eventsReportingResearchResearch PersonnelResearchersRiskSalutogenesisSample SizeSamplingSelf EfficacySelf RegulationSense of well-beingSlow-Onset Diabetes MellitusStable Diabetes MellitusStressT2 DMT2DT2DMTestingTimeTraumaTribesType 2 Diabetes MellitusType 2 diabetesType II Diabetes MellitusType II diabetesUnderserved PopulationVulnerable PopulationsWaiting ListsWell in selfWomanWorkacceptability and feasibilityadiposityadolescent womanadolescent womenadult onset diabetesagescardiovascular disease riskcardiovascular disordercardiovascular disorder riskcardiovascular healthclinical trial protocolcommunity based participatory researchcommunity interventioncommunity led researchcommunity participatory researchcommunity researchcoping strategycorpulencecostcultural valuesdata managementdesigndesigningdietsefficacy trialemotional wellbeingemotional wellnessenrollevidence baseexperiencefeasibility testinggroup interventionhealth care personnelhealth care workerhealth providerhealth related behaviorhealth workforcehealthcare personnelheart rate variabilityhistoriesimprovedinflammation markerinflammatory markerinjuriesinnovateinnovationinnovativeinstrumentintervention designintervention mappingintervention refinementinterventional strategyketosis resistant diabeteslife spanlifespanmaturity onset diabetesmedical personnelmenmental well-beingmental wellbeingmental wellnessmindfulnessmindfulness-based stress reductionmortalityoperationoperationsparticipatory action researchpilot studypost-trauma stress disorderposttrauma stress disorderprematureprematuritypreparationspreventpreventingprogramspromoting healthpsychologicpsychologicalpsychological wellbeingpsychological wellnesspsychosocial variablesracialracial backgroundracial originrandomisationrandomizationrandomized control trialrandomly assignedrecruitretention rateretention strategysecondary outcomeself wellnesssense of wellbeingskills trainingstress bufferingstress managementstress reductionstressortherapy designtraumatic neurosistreatment designtreatment providertrial planningtype 2 DMtype II DMtype two diabetesunder served groupunder served individualunder served peopleunder served populationunderserved groupunderserved individualunderserved peoplevulnerable groupvulnerable individualvulnerable peoplewaitlistyoung woman
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Full Description

PROJECT SUMMARY/ABSTRACT
Premature deaths due to cardiovascular disease (CVD) are increasing among American Indian women. Using a

collaborative intervention planning approach that blends community-based participatory research (CBPR)

principles and Intervention Mapping, we will implement a 3-year clinical trial planning project to adapt and

investigate the feasibility, acceptability, and initial efficacy of a multi-component cardiovascular health promotion

pilot intervention for American Indian women living in the southeast. First, we will adapt Mind Your Heart – an

intervention with cardiovascular health education, mindfulness self-regulation, and coping skills training –

culturally through qualitative formative research involving Talking Circles and Intervention Mapping with

American Indian women ages 18-50 at risk for CVD, tribal citizens, and American Indian healthcare providers

and traditional healers. Second, we will conduct a randomized controlled pilot study to examine feasibility,

acceptability, and initial efficacy of the adapted Mind Your Heart intervention in American Indian women at risk

for CVD. Third, we will refine the study infrastructure and intervention, obtain tribal and institutional review board

approval, modify recruitment and retention strategies, develop a Clinical Trials Protocol, develop a Manual of

Operations, and refine data collection and management procedures. Accomplishing these aims would provide

the foundation for a future R01 clinical trial that directly aligns with the National Heart, Lung, and Blood Institute's

scientific focus area of promoting cardiovascular health and preventing CVD across the lifespan. Preliminary

evidence on the acceptability and feasibility of the adapted Mind Your Heart intervention for American Indian

women would support the design and execution of a future R01 clinical trial to evaluate its efficacy. Our long-

term goal is to develop a sustainable cardiovascular health program that promotes positive psychological well-

being in American Indian women to prevent premature mortality from CVD.

Grant Number: 5R34HL158947-03
NIH Institute/Center: NIH

Principal Investigator: Jada Brooks

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