Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet.

Autor:	Mattei J; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.; FDI Clinical Research, San Juan, PR, USA., Díaz-Alvarez CB; FDI Clinical Research, San Juan, PR, USA., Alfonso C; College of Nutritionists and Dietitians of Puerto Rico, San Juan, PR, USA.; School of Health Sciences, Ana G. Méndez University, Gurabo Campus, Gurabo, PR, USA., O'Neill HJ; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA., Ríos-Bedoya CF; FDI Clinical Research, San Juan, PR, USA.; McLaren Health Care, Graduate Medical Education, Grand Blanc, MI, USA., Malik VS; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.; Department of Nutritional Sciences, University of Toronto, Ontario, Canada., Godoy-Vitorino F; Department of Microbiology, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA., Cheng C; Department of Biostatistics and Center for Methods in Implementation and Prevention Science, Yale School of Public Health, New Haven, CT, USA., Spiegelman D; Department of Biostatistics and Center for Methods in Implementation and Prevention Science, Yale School of Public Health, New Haven, CT, USA., Willett WC; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA., Hu FB; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA., Rodríguez-Orengo JF; FDI Clinical Research, San Juan, PR, USA.; Department of Biochemistry, School of Medicine, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA.
Jazyk:	angličtina
Zdroj:	Current developments in nutrition [Curr Dev Nutr] 2022 Dec 23; Vol. 7 (1), pp. 100022. Date of Electronic Publication: 2022 Dec 23 (Print Publication: 2023).
DOI:	10.1016/j.cdnut.2022.100022
Abstrakt:	Background: Adhering to a Mediterranean Diet (MedDiet) is associated with a healthier cardiometabolic profile. However, there are limited studies on the MedDiet benefits for non-Mediterranean racial/ethnic minorities, for whom this diet may be unfamiliar and inaccessible and who have a high risk of chronic diseases. Objectives: To describe the study design of a pilot trial testing the efficacy of a MedDiet-like tailored to adults in Puerto Rico (PR). Methods: The Puerto Rican Optimized Mediterranean-like Diet (PROMED) was a single-site 4-mo parallel two-arm randomized pilot trial among a projected 50 free-living adults (25-65 y) living in PR with at least two cardiometabolic risk factors (clinicaltrials.gov registration #NCT03975556). The intervention group received 1 individual nutritional counseling session on a portion-control culturally-tailored MedDiet. Daily text messages reinforced the counseling content for 2 mo, and we supplied legumes and vegetable oils. Participants in the control group received cooking utensils and one standard portion-control nutritional counseling session that was reinforced with daily texts for 2 mo. Text messages for each group were repeated for two more months. Outcome measures were assessed at baseline, 2 and 4 m. The primary outcome was a composite cardiometabolic improvement score; secondary outcomes included individual cardiometabolic factors; dietary intake, behaviors, and satisfaction; psychosocial factors; and the gut microbiome. Results: PROMED was designed to be culturally appropriate, acceptable, accessible, and feasible for adults in PR. Strengths of the study include applying deep-structure cultural components, easing structural barriers, and representing a real-life setting. Limitations include difficulty with blinding and with monitoring adherence, and reduced timing and sample size. The COVID-19 pandemic influenced implementation, warranting replication. Conclusions: If PROMED is proven efficacious in improving cardiometabolic health and diet quality, the findings would strengthen the evidence on the healthfulness of a culturally-appropriate MedDiet and support its wider implementation in clinical and population-wide disease-prevention programs. (© 2023 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu