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.

Development and Testing of a Mobile App for Management of Gestational Diabetes in Nepal: Protocol for a User-Centered Design Study and Exploratory Randomized Controlled Trial.

BACKGROUND: The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs) like Nepal. GDM self-management, including intensive dietary and lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse outcomes. However, in resource-limited settings, several barriers hinder optimal self-management. Mobile health (mHealth) technology holds promise as a strategy to augment GDM treatment by promoting healthy behaviors and supporting self-management, but this approach has not yet been tested in any LMIC. OBJECTIVE: This report describes the protocol to develop a culturally tailored mHealth app that supports self-management and treatment of GDM (GDM-Dhulikhel Hospital [GDM-DH] app, phase 1) and test its usability and preliminary efficacy (phase 2) among patients with GDM in a periurban hospital setting in Nepal. METHODS: The study will be conducted at Dhulikhel Hospital in Dhulikhel, Nepal. In the development phase (phase 1), a prototype of the GDM-DH app will be developed based on expert reviews and a user-centered design approach. To understand facilitators and barriers to GDM self-management and to gather feedback on the prototype, focus groups and in-depth interviews will be conducted with patients with GDM (n=12), health care providers (n=5), and family members (n=3), with plans to recruit further if saturation is not achieved. Feedback will be used to build a minimum viable product, which will undergo user testing with 18 patients with GDM using a think-aloud protocol. The final GDM-DH app will be developed based on user feedback and following an iterative product design and user testing process. In the randomized controlled trial phase (phase 2), newly diagnosed patients with GDM (n=120) will be recruited and randomized to either standard care alone or standard care plus the GDM-DH app from 24-30 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be maternal glycemic control at 6 weeks post partum, birth weight, and rates of labor induction and cesarean delivery. Qualitative data obtained from phase 1 will be analyzed using thematic analysis. In phase 2, independent 2-tailed t tests or chi-square analyses will examine differences in outcomes between the 2 treatment conditions. RESULTS: As of July 2024, we have completed phase 1. Phase 2 is underway. The first participant was enrolled in October 2021, with 99 participants enrolled as of July 2024. We anticipate completing recruitment by December 2024 and disseminating findings by December 2025. CONCLUSIONS: App-based lifestyle interventions for GDM management are not common in LMICs, where GDM prevalence is rapidly increasing. This proof-of-concept trial will provide valuable insights into the potential of leveraging mHealth app-based platforms for GDM self-management in LMICs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04198857; https://clinicaltrials.gov/study/NCT04198857. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59423.

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).

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 and 80 years of age diagnosed with moderately controlled T2D (HbA1c: 6.0 to 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 macronutrient targets to meet Mediterranean diet guidelines, in addition to 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 educational content as those in the UCC arm, following 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, in addition to real-time feedback on predicted post-prandial glycemic response (PPGR) to meals and snacks logged into the mobile app. DISCUSSION: The DiaTeleMed Study aims to 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: ClinicalTrials.gov NCT05046886. Registered on September 16, 2021.

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.