2022
Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet
Mattei J, Díaz-Alvarez C, Alfonso C, O’Neill H, Ríos-Bedoya C, Malik V, Godoy-Vitorino F, Cheng C, Spiegelman D, Willett W, Hu F, Rodríguez-Orengo J. Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet. Current Developments In Nutrition 2022, 7: 100022. PMID: 37181130, PMCID: PMC10100940, DOI: 10.1016/j.cdnut.2022.100022.Peer-Reviewed Original ResearchMediterranean-like dietNutritional counseling sessionsPilot trialHealthier cardiometabolic profileIndividual cardiometabolic factorsCardiometabolic risk factorsRandomized pilot trialDisease prevention programsCounseling sessionsDaily text messagesFree-living adultsCardiometabolic factorsCardiometabolic profileCardiometabolic healthSecondary outcomesPrimary outcomeRisk factorsDietary intakeIntervention groupChronic diseasesTwo-armOutcome measuresHigh riskMediterranean dietPsychosocial factors
2020
The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk
Spiegelman D, Lovato LC, Khudyakov P, Wilkens TL, Adebamowo CA, Adebamowo SN, Appel LJ, Beulens JW, Coughlin JW, Dragsted LO, Edenberg HJ, Eriksen JN, Estruch R, Grobbee DE, Gulayin PE, Irazola V, Krystal JH, Lazo M, Murray MM, Rimm EB, Schrieks IC, Williamson JD, Mukamal KJ. The Moderate Alcohol and Cardiovascular Health Trial (MACH15): Design and methods for a randomized trial of moderate alcohol consumption and cardiometabolic risk. European Journal Of Preventive Cardiology 2020, 27: 1967-1982. PMID: 32250171, PMCID: PMC7541556, DOI: 10.1177/2047487320912376.Peer-Reviewed Original ResearchConceptsModerate alcohol consumptionCardiovascular Health TrialAlcohol consumptionHealth trialsCardiovascular diseaseModerate alcoholNon-fatal ischemic strokeNon-fatal myocardial infarctionPrimary composite endpointCongestive heart failureCoronary heart diseaseModerate alcohol consumersAdults 50 yearsPublic health guidelinesAlcohol use disorderPreferred alcoholic beverageCardiometabolic effectsCardiometabolic riskCarotid revascularizationIschemic strokeSecondary outcomesComposite endpointHeart failurePrimary outcomeMyocardial infarctionVitamin D Supplements for Prevention of Tuberculosis Infection and Disease
Ganmaa D, Uyanga B, Zhou X, Gantsetseg G, Delgerekh B, Enkhmaa D, Khulan D, Ariunzaya S, Sumiya E, Bolortuya B, Yanjmaa J, Enkhtsetseg T, Munkhzaya A, Tunsag M, Khudyakov P, Seddon JA, Marais BJ, Batbayar O, Erdenetuya G, Amarsaikhan B, Spiegelman D, Tsolmon J, Martineau AR. Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease. New England Journal Of Medicine 2020, 383: 359-368. PMID: 32706534, PMCID: PMC7476371, DOI: 10.1056/nejmoa1915176.Peer-Reviewed Original ResearchConceptsVitamin D groupAcute respiratory infectionsVitamin D supplementationPlacebo groupRespiratory infectionsTuberculosis infectionD groupVitamin DTuberculosis diseaseD supplementationAdverse eventsQFT resultsPositive QFT resultWeekly oral doseVitamin D supplementsQuantiFERON-TB GoldProportion of childrenD supplementsSecondary outcomesPrimary outcomeOral doseD levelsImmune responseLower riskInfectionMortality under early access to antiretroviral therapy vs. Eswatini’s national standard of care: the MaxART clustered randomized stepped‐wedge trial
Chao A, Spiegelman D, Khan S, Walsh F, Mazibuko S, Pasipamire M, Chai B, Reis R, Mlambo K, Delva W, Khumalo G, Zwane M, Fleming Y, Mafara E, Hettema A, Lejeune C, Bärnighausen T, Okello V. Mortality under early access to antiretroviral therapy vs. Eswatini’s national standard of care: the MaxART clustered randomized stepped‐wedge trial. HIV Medicine 2020, 21: 429-440. PMID: 32458567, DOI: 10.1111/hiv.12876.Peer-Reviewed Original ResearchConceptsAntiretroviral therapyMortality rateDisease-related mortality rateCox proportional hazards modelCause mortality ratesStepped-wedge trialProportional hazards modelStepped-wedge designQuality of lifeEvidence of harmClinic transitionSecondary outcomesSOC participantsHealth clinicsLong-term consequencesImplementation trialHazards modelHIVStudy participantsMortalityHealth systemDecrease infectionEarly accessClinicTherapy
2019
Substituting brown rice for white rice on diabetes risk factors in India: a randomised controlled trial
Malik V, Sudha V, Wedick N, RamyaBai M, Vijayalakshmi P, Lakshmipriya N, Gayathri R, Kokila A, Jones C, Hong B, Li R, Krishnaswamy K, Anjana R, Spiegelman D, Willett W, Hu F, Mohan V. Substituting brown rice for white rice on diabetes risk factors in India: a randomised controlled trial. British Journal Of Nutrition 2019, 121: 1389-1397. PMID: 31006420, PMCID: PMC6948352, DOI: 10.1017/s000711451900076x.Peer-Reviewed Original ResearchConceptsBrown rice groupMetabolic syndromePrimary outcomeRisk factorsHigh-sensitivity C-reactive proteinRandomised cross-over trialT2D risk factorsDiabetes risk factorsC-reactive proteinCross-over trialType 2 diabetesWhite rice groupMeals/dHs-CRPSecondary outcomesElevated BMIWashout periodInsulin resistanceBlood glucoseEpidemiological evidenceWhite riceT2D riskUrban South IndiaBMISyndrome