2025
Learn-As-you-GO (LAGO) trials: optimizing treatments and preventing trial failure through ongoing learning
Bing A, Spiegelman D, Nevo D, Lok J. Learn-As-you-GO (LAGO) trials: optimizing treatments and preventing trial failure through ongoing learning. Biometrics 2025, 81: ujaf061. PMID: 40407021, PMCID: PMC12099308, DOI: 10.1093/biomtc/ujaf061.Peer-Reviewed Original ResearchConceptsIntervention packageBinary outcomesIntervention effectsConditional mean modelsOptimal intervention packagesOverall intervention effectContinuous outcomesComplex intervention packagesConfidence bandsInterval estimationImplementation trialLarge-scale intervention trialsMean modelIntervention trialsHypothesis testingInterventionStandard statistical methodsOutcomesTrialsConfidenceTheoryPower and Sample Size Calculations for Cluster Randomized Hybrid Type 2 Effectiveness‐Implementation Studies
Owen M, Curran G, Smith J, Tedla Y, Cheng C, Spiegelman D. Power and Sample Size Calculations for Cluster Randomized Hybrid Type 2 Effectiveness‐Implementation Studies. Statistics In Medicine 2025, 44: e70015. PMID: 39930740, DOI: 10.1002/sim.70015.Peer-Reviewed Original ResearchConceptsHybrid type 2 effectiveness-implementation studySample size calculationCluster randomized trialCluster randomized designSize calculationImplementation research outcomesReduce cardiovascular diseaseIssue of multiple testingEffective outcomesImplementation outcomesCommunity interventionsControl blood pressureBinary outcomesOutcomes approachLiterature searchMultiple testingCardiovascular diseaseInterventionRandomized trialsStandard statistical methodsBlood pressureOutcomesType 2 studies
2024
Estimation and inference for causal spillover effects in egocentric-network randomized trials in the presence of network membership misclassification
Chao A, Spiegelman D, Buchanan A, Forastiere L. Estimation and inference for causal spillover effects in egocentric-network randomized trials in the presence of network membership misclassification. Biostatistics 2024, 26: kxaf009. PMID: 40159413, PMCID: PMC11955068, DOI: 10.1093/biostatistics/kxaf009.Peer-Reviewed Original ResearchConceptsHIV Prevention Trials NetworkBehavioral changesImpact of interventionsPopulation behavior changePeer-based strategiesRandomized trialsIntervention effectsBehavioral interventionsStudy designSpillover effectsInterventionTrials NetworkInvestigate finite sample propertiesAverage spillover effectFinite sample propertiesBehavioral trainingParticipantsLeverage peer influenceMisclassificationDisseminate informationInterference settingOutcomesPeer influenceSurrogate networksSample propertiesNavigating grey areas in HIV and mental health implementation science
Harkness A, Giusto A, Hamilton A, Hernandez‐Ramirez R, Spiegelman D, Weiner B, Beidas R, Larson M, Lippman S, Wainberg M, Smith J. Navigating grey areas in HIV and mental health implementation science. Journal Of The International AIDS Society 2024, 27: e26271. PMID: 38923301, PMCID: PMC11197965, DOI: 10.1002/jia2.26271.Peer-Reviewed Original ResearchConceptsImplementation scienceNational Institute of Mental HealthImplementation researchMental healthImplementation strategiesImpact of implementation strategiesHIV Epidemic goalsInstitute of Mental HealthUNAIDS targetsFederal fundersResearch workforceHIV transmissionEvidence-basedGlobal HIVUnited StatesHIVCapacity buildingRecipient's perspectiveNational InstituteHealthExpert guidanceInterventionHigh-impact scienceControl groupOvercome challengesAssessing Direct and Spillover Effects of Intervention Packages in Network-randomized Studies
Buchanan A, Hernández-Ramírez R, Lok J, Vermund S, Friedman S, Forastiere L, Spiegelman D. Assessing Direct and Spillover Effects of Intervention Packages in Network-randomized Studies. Epidemiology 2024, 35: 481-488. PMID: 38709023, DOI: 10.1097/ede.0000000000001742.Peer-Reviewed Original ResearchIntervention packageEffectiveness of interventional packageImprove intervention deliveryPeer education interventionHIV prevention trialsPeer educator trainingMarginal structural modelsPublic health impactHIV risk behaviorsIntervention deliveryIntervention NetworkEducational interventionParticipant visitsPrevention trialsFollow-up visitRisk behaviorsHealth impactsInterventionEducational trainingParticipantsSpillover effectsVisitsHIVExposed networksPeer
2023
Overall, Direct, Spillover, and Composite Effects of Components of a Peer-Driven Intervention Package on Injection Risk Behavior Among People Who Inject Drugs in the HPTN 037 Study
Hernández-Ramírez R, Spiegelman D, Lok J, Forastiere L, Friedman S, Latkin C, Vermund S, Buchanan A. Overall, Direct, Spillover, and Composite Effects of Components of a Peer-Driven Intervention Package on Injection Risk Behavior Among People Who Inject Drugs in the HPTN 037 Study. AIDS And Behavior 2023, 28: 225-237. PMID: 37932493, PMCID: PMC11062514, DOI: 10.1007/s10461-023-04213-x.Peer-Reviewed Original ResearchInjection risk behaviorsPeer education interventionRisk behaviorsClinical trial registrationSubsequent risk behaviorsTRIAL REGISTRATIONOutcome ratesSecondary data analysisIndex individualsRoutine evaluationIntervention componentsIntervention NetworkMixed effects modelsIntervention packageGroups/networksPeer education trainingPeer educatorsOverall rateInterventionPeer educationEffects modelTraining sessionsDrugsControl conditionBehavioral measuresRandomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors
Puklin L, Harrigan M, Cartmel B, Sanft T, Gottlieb L, Zhou B, Ferrucci L, Li F, Spiegelman D, Sharifi M, Irwin M. Randomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors. Cancers 2023, 15: 4719. PMID: 37835412, PMCID: PMC10571774, DOI: 10.3390/cancers15194719.Peer-Reviewed Original ResearchBreast cancer survivorsCancer survivorsLifestyle interventionPhysical activityQuality of lifeBody weightWaitlist groupDiet qualitySelf-reported body weightWeight lossFavorable weight changeHealthy weight lossBody mass indexHealthy body weightGreater weight lossEvidence-based materialsDiverse healthcare settingsIntervention armMass indexClinical practicePositive behavior changeHealthcare settingsSurvivorsWeight changeIntervention
2021
Workplace cafeteria and other multicomponent interventions to promote healthy eating among adults: A systematic review
Naicker A, Shrestha A, Joshi C, Willett W, Spiegelman D. Workplace cafeteria and other multicomponent interventions to promote healthy eating among adults: A systematic review. Preventive Medicine Reports 2021, 22: 101333. PMID: 33732606, PMCID: PMC7937753, DOI: 10.1016/j.pmedr.2021.101333.Peer-Reviewed Original ResearchMulticomponent interventionHealthy eatingWorkplace cafeteriasDietary intakeWorkplace health interventionsEnglish-language articlesImproved health outcomesFood choicesHealth risksWeb of ScienceCOM-B systemHealth risk indicatorsVegetable intakeHigh intakeElectronic searchHealth outcomesSystematic reviewHealth interventionsNarrative summaryReview protocolIntakeInterventionCafeteria interventionsRisk indicatorsBehavioral changesUtilizing a church-based platform for mental health interventions: exploring the role of the clergy and the treatment preference of women with depression
Iheanacho T, Nduanya UC, Slinkard S, Ogidi AG, Patel D, Itanyi IU, Naeem F, Spiegelman D, Ezeanolue EE. Utilizing a church-based platform for mental health interventions: exploring the role of the clergy and the treatment preference of women with depression. Cambridge Prisms Global Mental Health 2021, 8: e5. PMID: 34026236, PMCID: PMC8127631, DOI: 10.1017/gmh.2021.4.Peer-Reviewed Original ResearchHealthy Beginning InitiativeTreatment preferencesMental health interventionsMental disordersHealth interventionsCommon mental disordersMental health screeningHealth-seeking behaviourResource-limited settingsHealth manpower shortagesMiddle-income countriesHealth screeningHealth beliefsHealth advisorsTherapyFree-listing exercisesDisordersWomenDepressionFocus group discussionsInterventionExerciseCommunity ChurchEffective strategyGroup discussions
2020
Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol
Pyakurel P, Shrestha A, Karmacharya BM, Budhathoki SS, Chaudhari RK, Tamrakar D, Shrestha A, Karmacharya RM, Shrestha A, Sharma S, Sharma SK, Spiegelman D. Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol. Open Heart 2020, 7: e001236. PMID: 32847993, PMCID: PMC7451278, DOI: 10.1136/openhrt-2019-001236.Peer-Reviewed Original ResearchMeSH KeywordsAdultBiomarkersBlood GlucoseDiabetes MellitusGlycated HemoglobinHealth BehaviorHealth Knowledge, Attitudes, PracticeHealthy LifestyleHumansMaleMiddle AgedMulticenter Studies as TopicNepalOccupational Health ServicesPatient Education as TopicPrediabetic StatePrimary PreventionRandomized Controlled Trials as TopicRisk Reduction BehaviorTime FactorsTreatment OutcomeConceptsBehavioral interventionsControl periodDiabetes risk reductionMonth control periodNepal Health Research CouncilBehavioral intervention groupWorksite intervention studiesT-testHealth Research CouncilInstitutional review boardTwo-sample t-testBlood sugarTrial protocolIntervention groupEthical approvalControl groupIntervention studiesType 2More monthsReview boardInterventionDiabetesParticipant changesPublic healthRisk reductionOptimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial
Barnhart DA, Semrau KEA, Zigler CM, Molina RL, Delaney MM, Hirschhorn LR, Spiegelman D. Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial. Implementation Science Communications 2020, 1: 29. PMID: 32885188, PMCID: PMC7427863, DOI: 10.1186/s43058-020-00014-8.Peer-Reviewed Original ResearchSafe Childbirth ChecklistComplex intervention developmentComplex interventionsBetterBirth ProgramWorld Health Organization Safe Childbirth ChecklistIntervention developmentIntervention packageEffective intervention componentsReal-world studyFuture complex interventionsNeonatal healthAdvanced stageIntervention componentsComplete data collectionTrialsInterventionHealth impactsImplementation intensityFull-scale trialFuture studiesOutcomesFull-scale evaluationEvaluation
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