IntroductionDespite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based Expecting intervention (NCT02125149) with pregnant women with obesity in community settings.Methods and analysisWe will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted Expecting intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol).Ethics and disseminationThis study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals.Trial registration numberNCT04298125; Pre-results.

Background Distinct molecular, inflammatory, and metabolic signatures are present in oocytes and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases. This study aims to assess the feasibility and efficacy of a peri-conception nutrition and exercise intervention on mitigating obesity-associated changes in oocyte gene expression profiles and follicular fluid metabolites. Methods This single blinded randomized control trial will include 120 women with a BMI of 25–45 kg/m2, ≥21 years of age, and undergoing in vitro fertilization (IVF) treatments. Participants will be randomized to standard of care (N = 60) or an intervention group (N = 60) in a block design by polycystic ovary syndrome status. The intervention will combine a dietary component (Mediterranean meal plan) with exercise prescription following the Physical Activity Guidelines for Americans. Participants will be assessed pre- and post-intervention. The standard of care group will be offered to join the intervention group if the IVF treatments are unsuccessful as a cross over design. Recruitment is anticipated to start in July of 2021. Primary outcomes will include single oocyte gene expression profiles and follicular fluid metabolites. Mann-Whitney U nonparametric tests will be used to assess potential differences for each stratum. Follicular fluid and serum metabolites will be analyzed using a one-factor Analysis of Covariance (ANCOVA) at four levels, pair-wise comparisons using Tukey-Kramer post-hoc tests will be used to identify groups whose means differ significantly while retaining the family-wise error rate at 5%. When the design is balanced, two-way Analysis of Variance (ANOVA), or non-parametric Friedman test will be used in data analysis. Additionally, general linear models and ANCOVA may be used to control for covariates. Significance will be set at p < 0.05. Findings will be disseminated via peer-reviewed manuscripts and presentations at scientific conferences. Discussion This study will provide novel data and key information on the impact of a dietary and exercise intervention on oocyte gene expression and follicular fluid content. Results will demonstrate the potential of such intervention in mitigating obesity-induced changes in oocyte gene expression and follicular fluid metabolites. Trial registration ClinicalTrials.gov (NCT04273048): submitted November 13, 2019; posted February 17, 2020.

No abstract

Objectives Human milk (HM) is impacted by both maternal obesity and diet. HM from women with obesity has higher fat, leptin and insulin concentrations. Additionally, maternal dietary fat intake is associated with increased HM fat content. The objective of this study was to determine the impact of a Mediterranean meal plan on the composition of HM from women with obesity. Methods In this pilot study, thirteen women with obesity (body mass index (BMI) ≥ 30 kg/m2) enrolled at five months post-partum and followed a provided Mediterranean meal plan focused on reducing fat intake and increasing unsaturated fat and fiber intake for four weeks. Participants’ diet was assessed using Nutrition Data System for Research. HM was collected at baseline and after the 4-week intervention and the concentrations of metabolites, hormones and cytokines were assayed. Wilcoxon signed-rank tests and analysis of variance were used to assess changes in participant diet and HM composition. Summary statistics are presented as mean ± standard deviation. Results The participants’ Healthy Eating Index Score, a measure of diet quality, significantly improved (38.3 ± 5.13 vs. 78.2 ± 6.75, p &lt; 0.001) and total fat intake was significantly lower (99.6 ± 23.3 g vs. 66.9 ± 12.0 g/day, p &lt; 0.001) after the intervention. Human milk leptin (694 ± 464 pg/ml vs. 437 ± 324 pg/ml, p = 0.007) and tumor necrosis factor α (0.515 ± 0.267 pg/ml vs. 0.310 ± 0.127 pg/ml, p = 0.010) concentrations were lower post intervention, whereas HM macronutrient composition was unchanged. The concentrations of several individual human milk oligosaccharides (HMO) and total HMOs (7720 ± 797 nmol/ml vs. 6986 ± 940 nmol/ml, p = 0.049), as well as HM tyrosine concentration (18.2 ± 6.16 nmol/ml vs. 14.5 ± 4.69 nmol/ml, p = 0.005) were significantly lower post intervention. Conclusions The composition of HM from women with obesity can be modulated by short-term adherence to a Mediterranean meal pattern. These findings merit further studies that use longer interventions and examine the impact of any changes in HM composition on infant growth and development. Modifying HM composition via a dietary intervention may provide a novel strategy to promote child development and health. Funding Sources USDA ARS #6026-51,000-010-05S and #6026-51,000-012-06S, NIH/NIDDK R01DK107516, Arkansas Children's Research Institute/Arkansas Biosciences Institute GR037121.

Objectives Human milk (HM) fatty acid content is, influenced by both maternal adiposity and diet. The objective of this study was to determine the impact of a Mediterranean meal plan on HM fatty acid content in women with obesity. Methods In this pilot study, thirteen women with obesity (body mass index (BMI) ≥ 30 kg/m2) enrolled at five months post-partum and were provided a Mediterranean meal plan for four weeks. Nutrition Data System for Research was used to assess participants’ diet during the study. HM was collected at baseline and after the 4-week intervention. Cytokines were measured using multi-spot assays and the fatty acid composition of triglycerides determined using a UHPLC electrospray ionization mass spectrometry. Triglycerides containing a particular fatty acid species were normalized to the total abundance of all triglyceride species detected in each sample. Wilcoxon signed-rank tests were used to assess changes in participant diet and HM composition, and repeated measures correlations were used to test associations of paired measures. Summary statistics are presented as mean ± standard deviation. Results During the intervention, the ratio of the maternal intake of ω6 and ω3 fatty acids (ω6: ω3) significantly decreased (8.86 ± 1.60 vs. 4.63 ± 1.25, P &lt; 0.001) and was positively correlated with HM levels of leptin and tumor necrosis factor-α (r = 0.64, p = 0.024 and r = 0.67, p = 0.017, respectively). Levels of human milk 20:3 (0.588 ± 0.085% vs. 0.483 ± 0.080%, P &lt; 0.001) and 22:4 (0.057 ± 0.012% vs. 0.050 ± 0.011%, p = 0.01) fatty acids were significantly decreased following the intervention. Maternal intake of ω6: ω3 positively correlated with HM 20:3 and 22:4 fatty acid concentrations (r = 0.78, p = 0.001 and r = 0.71, p = 0.005, respectively). Conclusions A 4-week Mediterranean meal plan modulated the fatty acid content in HM from women with obesity. There was an association between maternal ω6: ω3 intake and HM fatty acid content, supporting a role for maternal diet in modulating HM composition. Future studies are needed to investigate the effect of the intervention on specific fatty acids and whether the observed changes in HM impact infant growth or development. Funding Sources USDA ARS #6026–51,000-010–05S and #6026–51,000-012–06S, NIH/NIDDK R01DK107516, Arkansas Children's Research Institute/Arkansas Biosciences Institute GR037121.