Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes.

Background: The Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study is a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes (T2D). The study aims to test the efficacy of a personalized behavioral approach for dietary management of moderately-controlled T2D, versus a standardized behavioral intervention that uses one-size-fits-all dietary recommendations, versus a usual care control (UCC). The primary outcome will compare the impact of each intervention on the mean amplitude of glycemic excursions (MAGE). Methods: Eligible participants are between 21 to 80 years of age diagnosed with moderately-controlled T2D (HbA1c: 6.0-8.0%), and managed on lifestyle alone or lifestyle plus metformin. Participants must be willing and able to attend virtual counseling sessions and log meals into a dietary tracking smartphone application (DayTwo), and wear a continuous glucose monitor (CGM) for up to 12 days. Participants are randomized with equal allocation (n = 255, n = 85 per arm) to one of three arms: 1) Personalized, 2) Standardized, or 3) UCC. Measurements occur at 0 (baseline), 3, and 6 months. All participants receive isocaloric energy and macronutrients targets to meet Mediterranean diet guidelines plus 14 intervention contacts over 6 months (4 weekly then 10 biweekly) to cover diabetes self-management education. The first 4 UCC intervention contacts are delivered via synchronous videoconferences followed by educational video links. Participants in Standardized receive the same education content as UCC on the same schedule. However, all intervention contacts are conducted via synchronous videoconferences, paired with Social Cognitive Theory (SCT)-based behavioral counseling, plus dietary self-monitoring of planned meals using a mobile app that provides real-time feedback on calories and macronutrients. Participants in the Personalized arm receive all elements of the Standardized intervention, plus real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app. Discussion: The DiaTeleMed study will address an important gap in the current landscape of precision nutrition by determining the contributions of behavioral counseling and personalized nutrition recommendations on glycemic control in individuals with T2D. The fully remote methodology of the study allows for scalability and innovative delivery of personalized dietary recommendations at a population level. Trial registration: The DiaTeleMed Study is registered with ClinicalTrials.gov (Identifier: NCT05046886).

Prenatal Dietary Patterns and Associations With Weight-Related Pregnancy Outcomes in Hispanic Women With Low Incomes.

Background: Dietary patterns during pregnancy may contribute to gestational weight gain (GWG) and birthweight, but there is limited research studying these associations in racial and ethnic minority groups. The objective of this study was to evaluate associations between prenatal dietary patterns and measures of GWG and birthweight in a cohort of culturally diverse Hispanic women with low incomes. Methods: Data were analyzed from 500 mother-infant dyads enrolled in the Starting Early Program, a childhood obesity prevention trial. Diet over the previous year was assessed in the third trimester of pregnancy using an interviewer-administered food frequency questionnaire. Dietary patterns were constructed using the Healthy Eating Index-2015 (HEI-2015) and principal components analysis (PCA) and analyzed as tertiles. GWG and birthweight outcomes were abstracted from medical records. Associations between dietary pattern tertiles and outcomes were assessed by multivariable linear and multinomial logistic regression analyses. Results: Dietary patterns were not associated with measures of GWG or adequacy for gestational age. Greater adherence to the HEI-2015 and a PCA-derived dietary pattern characterized by nutrient-dense foods were associated with higher birthweight z-scores [ß: 0.2; 95% confidence interval (CI): 0.04 to 0.4 and ß: 0.3; 95% CI: 0.1 to 0.5, respectively], but in sex-specific analyses, these associations were only evident in male infants (ß: 0.4; 95% CI: 0.03 to 0.7 and ß: 0.3; 95% CI: 0.03 to 0.6, respectively). Conclusions: Among a cohort of culturally diverse Hispanic women, adherence to healthy dietary patterns during pregnancy was modestly positively associated with increased birthweight, with sex-specific associations evident only in male infants.

Predictors of Gestational Weight Gain in a Low-Income Hispanic Population: Sociodemographic Characteristics, Health Behaviors, and Psychosocial Stressors.

Hispanic women have a higher prevalence of weight associated complications in pregnancy. This ethnic disparity is likely related to behavior patterns, social circumstances, environmental exposures, and access to healthcare, rather than biologic differences. The objective was to determine associations between sociodemographic characteristics, health behaviors, and psychosocial stressors and gestational weight gain (GWG) in low-income Hispanic women. During pregnancy, information on sociodemographic characteristics, health behaviors, and psychosocial stressors were collected. Linear regression estimated mean differences in GWG by selected predictors. Multinomial logistic regression estimated odds of inadequate and excessive GWG by selected predictors. Five-hundred and eight women were included, 38% had inadequate and 28% had excessive GWG; 57% with a normal pre-pregnancy BMI had inadequate GWG. Compared to women with normal BMI, women with overweight or obesity were more likely to have excessive GWG (aRRR = 1.88, 95% CI: 1.04, 3.40 and aRRR = 1.98, 95% CI: 1.08, 3.62, respectively). Mean total GWG was higher among women who were nulliparous (ß = 1.34 kg, 95% CI: 0.38, 2.29) and those who engaged in ≥3 h of screen time daily (ß = 0.98 kg, 95% CI: 0.02, 1.94), and lower among women who were physically active during pregnancy (ß = -1.00 kg, 95% CI: -1.99, -0.03). Eating breakfast daily was associated with lower risk of inadequate GWG (aRRR = 0.47, 95% CI: 0.26, 0.83). Depressive symptoms and poor adherence to dietary recommendations were prevalent, but none of the psychosocial or dietary variables were associated with GWG. In this cohort of primarily immigrant, low-income, Hispanic women, there were high rates of poor adherence to diet and physical activity recommendations, and a majority of women did not meet GWG guidelines. Modifiable health behaviors were associated with GWG, and their promotion should be included in prenatal care.