Dataset Information

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.

SUBMITTER: Mattei J

PROVIDER: S-EPMC10100940 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Mattei Josiemer J Díaz-Alvarez Claudia B CB Alfonso Charmaine C O'Neill H June HJ Ríos-Bedoya Carlos F CF Malik Vasanti S VS Godoy-Vitorino Filipa F Cheng Chao C Spiegelman Donna D Willett Walter C WC Hu Frank B FB Rodríguez-Orengo José F JF

Current developments in nutrition 20221223 1

<h4>Background</h4>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.<h4>Objectives</h4>To describe the study design of a pilot trial testing the efficacy of a MedDiet-like tailored to adults in Puerto Rico (PR).<h4>Methods</h4>The Puerto Rican ...[more]

PMID: 37181130

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Project description:BackgroundTranscription factor 7-like 2 (TCF7L2) genetic variants that predispose individuals to type 2 diabetes (T2D) show inconsistent associations with anthropometric traits. Interaction between TCF7L2 genotypes and dietary factors may help explain these observations.ObjectiveWe aimed to examine the potential modulation of TCF7L2-rs7903146 and rs12255372 on anthropometric markers by a Mediterranean diet (MedDiet).MethodsCross-sectional analysis was conducted in 1120 participants (aged 45-75 y) of the Boston Puerto Rican Health Study. Anthropometric variables were measured, and polymorphisms were genotyped using standardized protocols. Diet was assessed using a validated FFQ. The MedDiet was defined based on adherence to 9 food and nutrient components using sex-specific population-based median cut-offs; high adherence was defined as meeting ≥4 components. Haplotypes were tested for association with obesity traits, independently and via interaction with the MedDiet.ResultsTCF7L2-rs7903146 showed significant interaction with the MedDiet influencing BMI, weight, and waist circumference. The T risk-allele carriers (CT + TT) with a high MedDiet score had lower weight (77.3 ± 1.0 compared with CC 80.9 ± 1.0 kg; P = 0.013) and waist circumference (99.2 ± 0.9 compared with CC 102.2 ± 0.9 cm; P = 0.021), when compared with CC participants. A low MedDiet score resulted in no significant differences between genotypes. For TCF7L2-rs12255372, we found significant interactions with the MedDiet for weight (P-interaction = 0.034) and BMI (P-interaction = 0.036). The T allele carriers with a higher MedDiet score showed a trend of lower but no significant differences when compared with CC participants for BMI (P = 0.19), weight (P = 0.09), and waist circumference (P = 0.11). We found significant interactions between the 2 risk-carrying haplotypes and the MedDiet compared with the common haplotype (GC), with lower BMI (β ± SE, TT: -1.53 ± 0.68; P-interaction = 0.024), weight (TT: -4.16 ± 1.77; P-interaction = 0.019), and waist circumference (GT: -5.07 ± 2.50; P-interaction = 0.042) at a high MedDiet score.ConclusionPuerto Ricans with the TCF7L2-rs7903146 and rs12255372 T2D risk genotypes, although still high, had better anthropometric profiles when adhering to a MedDiet, suggesting that this diet may offset unfavorable genetic predisposition.

Project description:Changes in dietary patterns may partly explain the epidemic of asthma in industrialized countries. The objective of this study was to examine the relationship between dietary patterns and lung function and asthma exacerbations in Puerto Rican children. This is a case-control study of 678 Puerto Rican children (ages 6-14 years) in San Juan (Puerto Rico). All participants completed a respiratory health questionnaire and a 75-item food frequency questionnaire. Food items were aggregated into 7 groups: fruits, vegetables, grains, protein, dairy, fats, and sweets. Logistic regression was used to evaluate consumption frequency of each group and asthma. Based on the results, a dietary score was created [range from -2 (unhealthy diet: high consumption of dairy and sweets, low consumption of vegetables and grains) to 2 (healthy diet: high consumption of vegetables and grains and low consumption of dairy and sweet)]. Multivariable linear or logistic regression was used to assess the relationship between dietary score and lung function or asthma exacerbations. After adjustment for covariates, a healthier diet (each 1-point increment in dietary score) was associated with significantly higher %predicted forced expiratory volume in the first second (FEV1) and %predicted forced vital capacity (FVC) in control subjects. Dietary pattern alone was not associated with asthma exacerbations, but children with an unhealthy diet and vitamin D insufficiency (plasma 25(OH)D <30 ng/mL) had higher odds of ≥1 severe asthma exacerbation [odds ratio (OR) = 3.4, 95% confidence interval (CI) = 1.5-7.5] or ≥1 hospitalization due to asthma (OR = 3.9, 95% CI = 1.6-9.8, OR = 3.4, 95% CI = 1.5-7.5) than children who ate a healthy diet and were vitamin D sufficient. A healthy diet, with frequent consumption of vegetables and grains and low consumption of dairy products and sweets, was associated with higher lung function (as measured by FEV1 and FVC). Vitamin D insufficiency, together with an unhealthy diet, may have detrimental effects on asthma exacerbations in children.

Project description:Background: Multiple diet quality scores have been used to evaluate adherence to specific dietary recommendations or to consumption of healthful foods and nutrients. It remains unknown which score can more strongly predict longitudinal changes in cardiometabolic risk factors.Objective: We aimed to determine associations of 5 diet quality scores [AHA diet score (AHA-DS), Dietary Approaches to Stop Hypertension (DASH), Healthy Eating Index (HEI)-2005, Mediterranean diet score (MeDS), and Alternative Healthy Eating Index (AHEI)] with 2-y changes in cardiometabolic risk factors in adults 45-75 y old.Methods: Data from the Boston Puerto Rican Health Study were analyzed (n = 1194). Diet quality scores were calculated from a baseline-validated food-frequency questionnaire. Multivariable-adjusted, repeated-subjects, mixed-effects models, adjusted for baseline measures, estimated associations between each z score and 14 individual cardiometabolic factors measured at 2 y.Results: MeDS was significantly associated with lower 2-y waist circumference (β coefficient ± SE: -0.52 ± 0.26, P = 0.048); body mass index (BMI; -0.23 ± 0.08, P = 0.005); log-insulin (-0.06 ± 0.02, P = 0.005); log-homeostasis model assessment of insulin resistance (HOMA-IR; -0.05 ± 0.02, P = 0.030), and log-C-reactive protein (-0.13 ± 0.03, P = 0.0002). Similar but weaker associations were observed for the AHEI with BMI, insulin, and HOMA-IR. The AHA-DS was inversely associated with BMI (-0.17 ± 0.08, P = 0.033). Neither the HEI-2005 nor DASH was significantly associated with any variable. Traditional Puerto Rican foods consumed by individuals with high MeDSs included vegetables and meats in homemade soups, orange juice, oatmeal, beans and legumes, fish, whole milk, corn oil, and beer.Conclusions: The MeDS comprises food components and scores associated with a favorable cardiometabolic profile over 2 y in Puerto Rican adults. An overall healthy diet may be particularly beneficial for maintaining a lower BMI. These results can help identify suitable measures of diet quality in epidemiologic studies and craft meaningful nutritional messages and dietary recommendations for the intended population. This study was registered at clinicaltrials.gov as NCT01231958.

Project description:BackgroundPrevious studies support cultural tailoring of recruitment materials as a strategy to promote the enrollment of minoritized groups in clinical trials. However, there is a lack of guidance for research teams to create culturally tailored materials, potentially contributing to low recruitment rates of minoritized groups. We describe the development and pilot testing of recruitment material guidelines used to culturally tailor clinical trial recruitment materials targeting African Americans and Latinos.MethodsThe guideline development team consisted of investigators, research staff, and community leaders and members experienced in the recruitment and community engagement of minoritized groups. The recruitment material guidelines were developed using the literature, focus groups with African Americans and Latinos, the teams' research experience, and guidance from a community advisory board. To assess the effectiveness of the guidelines, a pilot study was conducted comparing advertisement click-through rates and enrollment outcomes between two institutions differing in use of culturally tailored versus non-tailored Facebook banner ads for the "Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness" (ADAPTABLE) study.ResultsFive themes emerged from focus groups: (1) employ diversity and inclusion in recruitment efforts; (2) access multiple recruitment channels to increase reach and possible participation; (3) increase your "footwork"; (4) personalize outreach and recruitment to specific groups' beliefs and values; (5) align recruitment messaging with language preferences and motivations for study participation; and (6) specify incentives for participation. Guidelines were: 1) be inclusive; 2) use all forms of media; 3) take a personalized approach; 4) align recruitment messaging with motivations for study participation; 5) specify incentives; and 6) get out into the community. Additional guidelines were developed addressing specific considerations for images and language when targeting African American and Latino populations. Pilot study results demonstrated that clicks per impression ratio (0.47 clicks per impression vs. 0.03 clicks per impression) and the percentage of African American enrollment were significantly higher when using tailored compared to non-tailored ads (12.8% vs. 8.3%, respectively).ConclusionThe recruitment material guidelines offer practical recommendations to reach diverse populations for clinical trial participation more effectively. Our preliminary data supports use of these guidelines as a strategy to enhance recruitment of minoritized groups into clinical research studies.

Project description:ImportanceBenefits of breastfeeding are extensive, but racial and ethnic disparities persist. Mama Sana (Spanish for healthy mother) is a bilingual, culturally tailored program that aims to reduce breastfeeding inequities.ObjectiveTo examine differences in lactation support and breastfeeding outcomes among Spanish-speaking Hispanic birthing parents who participated in Mama Sana compared with a historical control (pre-Mama Sana) group.Design, setting, and participantsIn this cohort study, patients who participated in the Mama Sana program during their delivery hospitalization from January 2022 to September 2023 were compared with a historical control group who delivered prior to the implementation of the program (July 2019 to December 2021). The study took place at an academic medical center in Boston with a high-risk obstetric service. Data were analyzed from January to September 2024.ExposureBeginning in January 2022, a bilingual native Spanish-speaker licensed as a registered dietitian and certified lactation counselor provided lactation support to participants during their delivery hospitalization with follow-up phone calls after discharge (until 6 months post partum).Main outcomes and measuresThe primary outcome was exclusive breastfeeding at discharge. Secondary outcomes included any breastfeeding at discharge, any breastfeeding and exclusive breastfeeding at 6 weeks post partum, and change in maternal body mass index (BMI). Process measures included inpatient lactation consult placement and receipt of any and language-concordant lactation support. The χ2 test was used to analyze outcomes, process measures, and balancing measures.ResultsIn this study, 417 patients were included (Mama Sana group, 175 patients; mean [SD] age, 28.9 [6.1] years; pre-Mama Sana group: 242 patients; mean [SD] age, 29.8 [6.1] years). Sociodemographic characteristics including age and BMI were similar between groups. Mama Sana participants were less likely to be multiparous or to have diabetes compared with the pre-Mama Sana group. At hospital discharge, 36 of 175 Mama Sana participants (20.6%) were exclusively breastfeeding compared with 39 of 242 pre-Mama Sana (16.1%) (adjusted risk difference [aRD], 2.5%; 95% CI, -1.2 to 6.4). Significantly more Mama Sana participants engaged in any breastfeeding prior to hospital discharge (172 of 175 [98.3%] vs 222 of 242 [91.7%]; aRD, 7.1%; 95% CI, 2.8% to 11.5%) and at the 6 week postpartum visit (81 of 102 [79.4%] vs 109 of 170 [64.1%]; aRD, 15.6%; 95% CI, 4.8% to 26.4%) compared with the pre-Mama Sana group. More Mama Sana participants had a lactation consult placed (109 of 175 [62.3%] vs 108 of 242 [44.6%]; P < .001) and received lactation support in Spanish (175 of 175 [100%] vs 49 of 242 [20.3%]; P < .001) than those in the pre-Mama Sana group.Conclusions and relevanceIn this cohort study, Mama Sana's language-concordant, culturally tailored lactation program was associated with higher rates of lactation support and some breastfeeding outcomes, which suggests the program may be a useful approach to perinatal care equity.

Dataset Information

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

Background

Objectives

Methods

Results

Conclusions

Publications

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

Similar Datasets

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