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The EMBER Trial for Weight Management Engagement

The EMBER Trial for Weight Management Engagement
参与体重管理的 EMBER 试验
批准号:
10315463
负责人:
Jessica Yelena Breland
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-02-01 至 2025-08-31
关键词:
AddressAffectBehaviorBehavioralBeliefBody Weight decreasedCardiovascular DiseasesCardiovascular systemCessation of lifeColorComplications of Diabetes MellitusDataDiabetes MellitusDiseaseDissemination and ImplementationEffectivenessEnsureExerciseFood ServicesGoalsHealthHealth PromotionHealth Services AccessibilityHealth Services AdministrationHeart DiseasesHybridsInterventionInterviewK-Series Research Career ProgramsLettersMalignant NeoplasmsMethodologyMethodsModelingMorbidity - disease rateMotivationObesityOrganization and AdministrationOutcomePain managementPaperParticipantPatient Self-ReportPatient-Centered CarePatientsPersonsPhysical activityPilot ProjectsPopulationPrimary Health CareQuality of lifeRandomizedResearchResearch DesignResearch PriorityRiskScienceSelf EfficacySelf-DirectionSeriesServicesSiteSystemTestingTimeTouch sensationTranslatingUnited StatesUnited States Health Resources AdministrationVeteransVeterans Health AdministrationWeightWeight GainWeight maintenance regimenWomanWorkarmbasebehavioral healthcomorbiditycostdesigndigitaldisorder preventioneffectiveness implementation trialflexibilityfollow-uphealth equityhealth service usehigh riskhigh risk populationhybrid type 1 designhybrid type 1 trialhybrid type 2 trialimplementation outcomesimplementation scienceimplementation strategyimprovedinnovationinterestmortalitymotivational enhancement therapynovelnutritionobese patientsobesity riskpatient orientedpeople of colorphysical conditioningpopulation healthprimary outcomeprogramssecondary outcomeself helpsevere COVID-19smoking cessationtherapy designtoolvirtual healthcare

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Background: Almost 40% of Veterans using the Veterans Health Administration (VA) have obesity, putting millions at risk for costly and debilitating conditions, including diabetes, cancer, and severe COVID-19. VA weight management programs effectively reduce weight, morbidity, and mortality. For example, MOVE!, VA’s flagship program for weight management is associated with reductions in cardiovascular disease and diabetes. However, while 94% of eligible Veterans are offered weight management programs, less than 8% use them. Motivational interviewing improves treatment engagement, but clinicians have limited time to apply it. Therefore, we developed EMBER, a self-directed tool with the goal of Enhancing Motivation for Better Engagement and Reach for weight management. It is available in paper and digital formats. EMBER is not a weight management program, instead it engages Veterans in existing programs by informing and guiding choices about weight management. EMBER is the product of an HSR&D Career Development Award (15-257). Significance: If EMBER increases engagement in effective weight management programs, it has the potential to help Veterans lose weight, thereby improving health and quality of life for thousands of patients. As a result, we address many HSR&D priorities, e.g., access to care, virtual care, healthy equity, & primary care. Innovation & Impact: EMBER is the first self-directed, motivational interviewing-based intervention designed to increase Veteran engagement in weight management programs. As opposed to a “one-off” study in a specific population, the proposed work takes a novel, low-touch population health approach that could be translated to other programs (e.g., behavioral pain management). EMBER also includes vignettes relevant to populations at high risk for obesity (e.g., women, people of color). Further, t he Hybrid Type 1 design will ensure results can be scaled and sustained while also advancing implementation science. As such, the proposed work will: 1) advance the science of engagement in behavioral health programs and 2) facilitate future research on the implementation of EMBER and similar interventions. Specific Aims: 1. Assess whether Veterans randomized to EMBER are more likely to have any weight management engagement at 2-month follow-up (per administrative data supplemented with self-report) compared to those randomized to the control arm (information sheet listing available programs). (Primary Outcome) 2. Assess whether Veterans randomized to EMBER have greater weight management program retention, weight management behaviors (e.g., physical activity), weight loss, and quality of life gains at 6-month follow-up compared to those randomized to the control arm. (Secondary Outcomes) 3. Assess factors likely to affect EMBER’s implementation. Preliminary implementation outcomes will be assessed via RE-AIM4 (Reach, Effectiveness, Implementation) and the Proctor et al.5 implementation outcomes framework (Acceptability, Appropriateness, Costs, Fidelity). (Implementation Outcomes) Randomized two site Hybrid Type 1 Effectiveness-Implementation Trial among Veteran primary care patients with obesity in VA (N=470). Participants will be randomized to EMBER or a control condition consisting of a list of available weight management programs. The primary outcome is any weight management engagement 2-months after baseline. Aims 1 and 2 will use self-report and administrative data to assess intervention outcomes. Aim 3 will use patient data and information from research staff. Methodology: Implementation/Next Steps: If effective, we will use implementation strategies suggested by Aim 3 to ensure Veterans receive EMBER. We will test these strategies in a Hybrid Type 2 trial to understand EMBER’s effectiveness in real world contexts and best practices for dissemination and implementation of EMBER and similar interventions.
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