{"doi":"10.1016/j.cdnut.2022.100022","title":"Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet","abstract":"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.","journal":"Current Developments in Nutrition","year":2022,"id":272292,"datarank":0.644756131877636,"base_score":2.5649493574615367,"endowment":2.5649493574615367,"self_citation_contribution":0.38474240361923057,"citation_network_contribution":0.26001372825840546,"self_endowment_contribution":0.38474240361923057,"citer_contribution":0.26001372825840546,"corpus_percentile":null,"corpus_rank":null,"citation_count":12,"citer_count":11,"citers_with_citation_signal":9,"citers_with_endowment":9,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9605,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03975556"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":938839,"name":"Claudia B. Díaz-Alvarez","orcid":null,"position":1,"is_corresponding":false},{"id":343290,"name":"Charmaine Alfonso","orcid":null,"position":2,"is_corresponding":false},{"id":384762,"name":"H. J. O’Neill","orcid":"0000-0003-3982-6515","position":3,"is_corresponding":false},{"id":938840,"name":"Carlos F. Ríos‐Bedoya","orcid":null,"position":4,"is_corresponding":false},{"id":509838,"name":"Vasanti Malik","orcid":"0000-0002-9453-4796","position":5,"is_corresponding":false},{"id":237259,"name":"Filipa Godoy‐Vitorino","orcid":"0000-0003-1880-0498","position":6,"is_corresponding":false},{"id":938322,"name":"Chao Cheng","orcid":"0000-0003-3571-8154","position":7,"is_corresponding":false},{"id":332379,"name":"Donna Spiegelman","orcid":"0000-0003-4006-4650","position":8,"is_corresponding":false},{"id":104570,"name":"Walter C. Willett","orcid":"0000-0003-1458-7597","position":9,"is_corresponding":false},{"id":55333,"name":"Frank B. Hu","orcid":"0000-0002-8233-6274","position":10,"is_corresponding":false},{"id":412429,"name":"José F. Rodríguez‐Orengo","orcid":null,"position":11,"is_corresponding":false},{"id":341235,"name":"Josiemer Mattei","orcid":"0000-0001-5424-8245","position":0,"is_corresponding":true}],"reference_count":121,"raw_metadata":null,"created_at":"2026-07-19T00:27:43.806977Z","pmid":"37181130","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}