grant

The EMBER Trial for Weight Management Engagement

Organization VETERANS ADMIN PALO ALTO HEALTH CARE SYSLocation PALO ALTO, UNITED STATESPosted 1 Feb 2022Deadline 30 Sept 2026
VANIHUS FederalResearch GrantFY2026Access to CareActive Follow-upAddressAffectBehaviorBehavioralBeliefBody Weight decreasedCancersCardiac DiseasesCardiac DisordersCardiovascular DiseasesCareer Development AwardsCareer Development Awards and ProgramsCareer Development Programs K-SeriesCessation of lifeColorComplications of Diabetes MellitusDataDeathDiabetes ComplicationsDiabetes MellitusDiabetes-Related ComplicationsDiabetic ComplicationsDiseaseDisorderDissemination and ImplementationEffectivenessEligibilityEligibility DeterminationEnsureEquityExerciseFood ServicesGoalsHealthHealth PromotionHealth Resources AdministrationHealth Services AccessibilityHealth Services AdministrationHeart DiseasesHybridsInterventionInterviewK-AwardsK-Series Research Career ProgramsLettersMalignant NeoplasmsMalignant TumorMethodologyMethodsModelingMorbidityMotivationNutritionObesityOrganization and AdministrationOutcomePain ControlPain TherapyPain managementPaperParticipantPatient Self-ReportPatient-Centered CarePatientsPersonsPhysical activityPilot ProjectsPopulationPrimary CareProtocol ScreeningQOLQuality of lifeRE-AIMRandomizedReach, Effectiveness, Adoption, Implementation, and MaintenanceResearchResearch Career ProgramResearch DesignResearch PriorityRiskSalutogenesisScienceSelf DirectionSelf EfficacySelf-ReportSeriesServicesSiteStudy TypeSystemTestingTimeTouchTouch sensationTranslatingUnited StatesUnited States Health Resources AdministrationVeteransVeterans Health AdministrationVeterans Health AffairsWeightWeight GainWeight IncreaseWeight LossWeight ReductionWeight maintenance regimenWomanWorkaccess to health servicesaccess to servicesaccess to treatmentaccessibility to health servicesactive followupadiposityarmavailability of servicesbehavioral healthbody weight gainbody weight increasebody weight losscardiovascular disordercare accesscease smokingco-morbidco-morbiditycomorbiditycorpulencecostdesigndesigningdiabetesdigitaldisease preventiondisorder preventioneffectiveness and implementation trialeffectiveness/implementation hybrid trialeffectiveness/implementation trialflexibilityflexiblefollow upfollow-upfollowed upfollowupgroup of colorhealth equityhealth service accesshealth service usehealth service utilizationhealth services availabilityheart disorderhigh riskhigh risk grouphigh risk individualhigh risk peoplehigh risk populationhybrid type 1 designhybrid type 1 factorial designhybrid type 1 trialhybrid type 2 trialhybrid type I designhybrid type I trialhybrid type II trialimplementation outcomesimplementation scienceimplementation strategyimprovedindividual of colorinnovateinnovationinnovativeinterestintervention designlife-threatening COVIDlife-threatening COVID-19life-threatening SARS-CoV-2life-threatening coronavirus diseaselife-threatening coronavirus disease 2019life-threatening severe acute respiratory syndrome coronavirus 2malignancymortalitymotivational enhancement therapymotivational interviewneoplasm/cancernovelobese patientsobesity riskpain interventionpain treatmentpatient centeredpatient orientedpatients with obesitypeople of colorperson of colorphysical conditioningphysical healthpilot studypopulation healthpopulation of colorprimary care patientprimary care practiceprimary outcomeprogramspromoting healthquit smokingrandomisationrandomizationrandomly assignedreach, efficacy, adoption, implementation, and maintenancerisk for obesityrisk of obesitysecondary outcomeself helpserious COVIDserious COVID-19serious SARS-CoV-2serious coronavirus diseaseserious coronavirus disease 2019serious severe acute respiratory syndrome coronavirus 2service availabilitysevere COVIDsevere COVID-19severe COVID19severe SARS-CoV-2severe coronavirus diseasesevere coronavirus disease 19severe coronavirus disease 2019severe severe acute respiratory syndrome coronavirus 2smoking cessationstop smokingstrategies for implementationstudy designtactile sensationtherapy designtooltreatment accesstreatment designvirtual carevirtual health careweight controlweight managementweightswt gainwt-loss
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Full Description

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.

Grant Number: 5I01HX003082-05
NIH Institute/Center: VA

Principal Investigator: Jessica Breland

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