Case report: Glycaemic management and pregnancy outcomes in a woman with an insulin receptor mutation, p.Met1180Lys.

BACKGROUND: Heterozygous insulin receptor mutations (INSR) are associated with insulin resistance, hyperglycaemia and hyperinsulinaemic hypoglycaemia in addition to hyperandrogenism and oligomenorrhoea in women. Numerous autosomal dominant heterozygous mutations involving the INSR ß-subunit tyrosine kinase domain resulting in type A insulin resistance have been previously described. We describe the phenotype, obstetric management and neonatal outcomes in a woman with type A insulin resistance caused by a mutation in the ß-subunit of the INSR. CASE PRESENTATION: We describe a woman with a p.Met1180Lys mutation who presents with hirsutism, oligomenorrhoea and diabetes at age 20. She has autoimmune thyroid disease, Coeliac disease and positive GAD antibodies. She is overweight with no features of acanthosis nigricans and is treated with metformin. She had 11 pregnancies treated with insulin monotherapy (n = 2) or combined metformin and insulin therapy (n = 9). The maximum insulin dose requirement was 134 units/day or 1.68 units/kg/day late in the second pregnancy. Mean birthweight was on the 37th centile in INSR positive offspring (n = 3) and the 94th centile in INSR negative offspring (n = 1). CONCLUSION: The p.Met1180Lys mutation results in a phenotype of diabetes, hirsutism and oligomenorrhoea. This woman had co-existent autoimmune disease. Her insulin dose requirements during pregnancy were similar to doses observed in women with type 2 diabetes. Metformin may be used to improve insulin sensitivity in women with this mutation. Offspring inheriting the mutation tended to be smaller for gestational age.

An mHealth-Supported antenatal lifestyle intervention may be associated with improved maternal sleep in pregnancy: Secondary analysis from the PEARS trial.

OBJECTIVE: To investigate the effect of an antenatal diet and exercise intervention during pregnancy on sleep duration. As a secondary objective, associations between sleep duration and gestational weight gain (GWG), maternal metabolic parameters and pregnancy outcomes were assessed. DESIGN: Secondary analysis. SETTING: Large tertiary Maternity Hospital in Dublin, Ireland. POPULATION: 326 women with overweight or obesity who participated in the Pregnancy Exercise And Nutrition Research Study (PEARS) randomised controlled trial between March 2013 and August 2016. METHODS: Secondary analysis of a randomised trial. MAIN OUTCOME MEASURES: Impact of the PEARS intervention on sleep duration, and association of sleep duration and maternal metabolic parameters, and pregnancy outcomes. RESULTS: Participants had a mean age of 32.5 ± 4.5 years and median (interquartile range [IQR]) body mass index of 28.3 (26.6-31.2) kg/m2 . The intervention group had a longer sleep duration in late pregnancy (mean difference 17.1 minutes (95% confidence interval [CI] 0.5-33.7) and a higher proportion achieving optimum sleep duration of 7-9 h (54.3 vs. 42.9%, relative risk [RR] 1.28 (95% CI 1.01-1.62). In late pregnancy, sleep duration of <6 h was associated with lower breastfeeding rates on discharge (RR 0.74, 95% CI 0.57-0.95) and higher triglyceride levels (mean difference 0.24, 95% CI 0.10-0.38). There were no significant associations between sleep and incidence of gestational diabetes mellitus or pre-eclampsia/toxaemia, or other metabolic parameters assessed (insulin, fasting glucose, HOMA-IR). CONCLUSION: A diet and exercise intervention from early pregnancy may promote longer and optimal sleep duration, with maternal benefits such as lower triglyceride levels and higher breastfeeding rates.

Herpes encephalitis and hepatitis in pregnancy: A case report and literature review.

We present the case of a healthy nulliparous woman who presented with persistent fever, proteinuria and elevated transaminases at 33 weeks' gestation. Following initial treatment for suspected chorioamnionitis and potential pre-eclampsia, she had a caesarean section delivering a healthy male infant. However, on her third post-operative day, she developed neurological symptoms and accompanying severe sepsis, necessitating inotropic support and transfer to a higher level of care. A comprehensive work-up revealed herpes simplex Virus-2 (HSV-2) in serum and cerebrospinal fluid. Abdominal imaging was suggestive of accompanying hepatitis with micro-abscesses. This lady recovered well following intravenous acyclovir for 14 days. Her infant was not affected and was discharged home with his mother. Herpes simplex encephalitis and hepatitis associated with HSV-2 have been described three times previously in pregnancy. We delineate the diagnostic challenges that rare conditions such as this pose and emphasise the importance of multi-disciplinary care in managing complicated medical conditions in pregnancy.

The Edmonton Obesity Staging System and pregnancy outcomes in women with overweight or obesity: A secondary analysis of a randomized controlled trial.

The Edmonton Obesity Staging System (EOSS) is a proposed clinical practice tool to determine obesity severity. In a secondary analysis of the Pregnancy Exercise and Research Study (PEARS) (a mobile-health-supported lifestyle intervention among pregnant women with body mass index [BMI] ≥25 kg/m2 ), we apply the EOSS and explore relationships with pregnancy outcomes. In early (14-16 weeks) and late (28 weeks) pregnancy, fasting lipids and glucose were measured, blood pressure was extracted from medical records and maternal well-being was assessed using the WHO-5 Well-being Index. Pearson's correlations, chi-square statistics and multiple logistic regression were used to identify relationships. One-way analysis of variance was used to compare groups. Pregnant women (n = 348) were mean (SD) age 32.44 (4.39) years and median (interquartile range) BMI 28.0 (26.57, 29.88) kg/m2 . Using metabolic criteria only, 81.9% and 98.9% had raised EOSS scores in early and late pregnancy. From early to late pregnancy, EOSS scores increased by 60.1%. Of these, 10.5% experienced a 2-point increase, moving from stage 0 to stage 2. There was a potential relationship between early EOSS and large for gestational age (χ2  = 6.42, df (2), p = .04), although significance was lost when controlled for confounders (p = .223) and multiple testing. Most women with BMI ≥25 kg/m2 had raised EOSS scores, limiting the clinical utility of the tool.

Maternal Well-Being and Stage of Behaviour Change during Pregnancy: A Secondary Analysis of the PEARS Randomised Controlled Trial.

We aimed to determine whether early pregnancy well-being was associated with the stage of behaviour change during an antenatal lifestyle intervention using a secondary analysis of data from the Pregnancy Exercise and Nutrition Research Study (PEARS). Pregnant women (n = 277) with well-being data in early pregnancy were included. Maternal well-being was measured using the World Health Organisation Five-Item Well-Being Index. The intervention consisted of a mobile health (mHealth) phone application, supported by antenatal education and exercise, to prevent gestational diabetes in a population with overweight. Stage of behaviour change was measured in late pregnancy using a five-stage classification. Ordinal logistic regression was used to examine if well-being, the study group, or their interaction, were related to behaviour change. Maternal well-being (OR 1.03, 95% CI 1.01, 1.04, p < 0.01) and the study group (OR 2.25, 95% CI 1.44, 3.51, p < 0.01) both significantly influenced the positive stage of behaviour change. The probability of being at stage 5 increased from 43 to 92% as well-being increased from 0 to 100% and was higher in the intervention (53%) compared to the control (34%) group (p ≤ 0.01 (8.65, 29.27). This study demonstrates the potential importance of well-being in enabling women to engage with a healthy lifestyle, and the role that mHealth technology has in facilitating beneficial behaviour change.

Maternal C3 complement and C-reactive protein and pregnancy and fetal outcomes: A secondary analysis of the PEARS RCT-An mHealth-supported, lifestyle intervention among pregnant women with overweight and obesity.

OBJECTIVES: Elevated circulating levels of complement component 3 (C3) and C-reactive protein (CRP) have been linked with adverse pregnancy outcomes. Lifestyle interventions may hold potential to ameliorate these effects. We investigated the effect of an antenatal healthy lifestyle intervention on maternal C3 and CRP concentrations and assessed their relationship with maternal and fetal metabolic markers and outcomes. STUDY DESIGN: Secondary analysis of data from the Pregnancy Exercise And Nutrition Research Study (PEARS) randomized controlled trial. METHODS: Women (n = 406) with C3 and CRP concentrations determined in early pregnancy (14-16 weeks) and/or late pregnancy (28-weeks) with corresponding fasting glucose, insulin, c-peptide, and lipid profiles were included in the analysis. Pregnancy outcomes included: diagnoses of gestational diabetes (GDM), pre-eclampsia (PET) or pregnancy induced hypertension (PIH), pre-term birth (delivery < 37 weeks), low birth weight (<2500 g), small-for-gestational age (SGA) defined using < 5th or 10th centile for birthweight and cord blood measures of glucose and lipid metabolism. T-tests investigated changes in C3 and CRP over time. Chi-square, Pearson's' correlations and multiple regression investigated relationships with outcomes. RESULTS: The PEARS intervention did not influence maternal C3 or CRP concentrations in pregnancy. There was no relationship between CRP concentrations and any maternal or infant outcome. Women who developed GDM had higher C3 concentrations in early (p = 0.01) and late pregnancy (p = 0.02). Women who developed PIH/PET had lower C3 concentrations in early (p = 0.02), but not late (p = 0.10) pregnancy. Maternal C3 concentrations in early pregnancy were a small but significant predictor of maternal insulin concentrations in early (ß = 0.40, 95% CI 0.27, 0.53; p < 0.001) and late (ß = 0.30, 95% CI 0.17, 0.43p < 0.001) pregnancy, early total cholesterol (TC), and both early and late triglycerides, LDL and HDL Cholesterol concentrations (all p < 0.001). Women who delivered SGA babies (<10th centile) had lower C3 concentrations than women who did not in both early (p < 0.001) and late pregnancy (p = 0.01). No relationship between maternal C3 or CRP and fetal glucose concentrations or lipid profiles was observed. CONCLUSION: Maternal C3 may play a role in multiple adverse pregnancy outcomes including cardiometabolic ill-health. Further research on this, and strategies to reduce C3 in a pregnant population, are warranted.

Effect of an Antenatal Lifestyle Intervention on Dietary Inflammatory Index and Its Associations with Maternal and Fetal Outcomes: A Secondary Analysis of the PEARS Trial.

We investigated the effect of an antenatal lifestyle intervention of a low-glycaemic index (GI) diet and physical activity on energy-adjusted dietary inflammatory index (E-DIITM) and explored its relationship with maternal and child health in women with overweight and obesity. This was a secondary analysis of 434 mother-child pairs from the Pregnancy Exercise and Nutrition Study (PEARS) trial in Dublin, Ireland. E-DIITM scores were calculated for early (10-16 weeks) and late (28 weeks) pregnancy. Outcomes included lipids, inflammation markers, insulin resistance, mode of delivery, infant size, pre-eclampsia, and gestational diabetes. T-tests were used to assess changes in E-DIITM. Chi-square, correlations, and multiple regression were employed to investigate relationships with outcomes. The mean (SD) age of participants was 32.45 (4.29) years with median (IQR) BMI 28.25 (26.70, 31.34) kg/m2. There was no change in E-DIITM in the controls (-0.14 (1.19) vs. -0.07 (1.09), p = 0.465) but E-DIITM reduced by 10% after the intervention (0.01 (1.07) vs -0.75 (1.05), p < 0.001). No associations were found between early pregnancy E-DIITM and maternal and child outcomes, except for increased odds of adverse cardiometabolic phenotype in women who delivered male (OR = 2.29, p = 0.010) but not female infants (OR = 0.99, p = 0.960). A low-GI antenatal intervention can reduce the inflammatory potential of diets. Sex differences should be explored further in future research.

Acceptability of the Pregnancy, Exercise, and Nutrition Research Study With Smartphone App Support (PEARS) and the Use of Mobile Health in a Mixed Lifestyle Intervention by Pregnant Obese and Overweight Women: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: Dietary interventions can improve pregnancy outcomes among women with increased BMI. Although the interest in mobile health interventions is growing, little is known about the acceptability of smartphone apps to support lifestyle interventions in such a cohort. OBJECTIVE: We aimed to assess the acceptability of the pregnancy, exercise, and nutrition research study with smartphone app support (PEARS) and the use of mobile health in a mixed lifestyle intervention delivered to overweight and obese pregnant women. METHODS: PEARS was a randomized controlled trial of a low glycemic index dietary intervention with exercise prescription and a smartphone app, which was delivered to pregnant women who were overweight or obese. Acceptability questionnaires were completed by the intervention group at 28 weeks of gestation (n=149) and at postintervention (n=123). Maternal characteristics were recorded (ie, age, ethnicity, BMI, socioeconomic status). Associations between maternal characteristics and acceptability of the intervention and app were analyzed using two-tailed t tests, Mann-Whitney U tests, chi-square test, and logistic regression. One-on-one semistructured interviews were conducted with a subcohort of the intervention participants (n=28) at 34 weeks of gestation, in which the participants shared their experiences of the PEARS intervention. RESULTS: The intervention was generally accepted, with respondents agreeing that the diet was easy to follow (98/148, 68.5%), enjoyable (106/148, 74.1%), and affordable (110/148, 76.9%). Qualitative and quantitative results were consistent with each another, both demonstrating that app acceptability was high. The participants agreed that the app was enjoyable (96/120, 80.0%) and easy to use (116/119, 97.5%). Compared to those with tertiary education, those with lower education levels were more likely to enjoy the dietary changes (P=.04). Enjoyment of the app was associated with disadvantaged neighborhood deprivation index (P=.01) and higher BMI (P=.03). CONCLUSIONS: The PEARS intervention and use of a supportive smartphone app were accepted by pregnant women, particularly by those from vulnerable subgroups of this population. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 29316280; https://www.isrctn.com/ISRCTN29316280.

Limited Impact of Fetal Sex and Maternal Body Mass Index on Fetal and Maternal Insulin Resistance and Lipid Metabolism: Findings from the PEARs Study.

The intrauterine environment can have a significant impact on fetal and maternal well-being, both during pregnancy and in later life. We aimed to identify how fetal sex and maternal body mass index (BMI) influence insulin resistance and metabolic function during pregnancy with maternal BMI > 25 kg/m2. This secondary analysis assessed data from the PEARS-randomized controlled trial that recruited pregnant women with body mass indexes 25-39.9 kg/m2. Longitudinal measurements of maternal and fetal insulin resistance and metabolic function were recorded throughout pregnancy. Regression models tested the effects of fetal sex and maternal BMI on markers of metabolic function and insulin regulation. A total of 484 women and their newborns (252 (52%) males vs. 232 (48%) females) were included in the analysis. A total of 333 (69%) women were overweight and 151 (31%) were obese. Male newborns were heavier and larger than females, and had a higher rate of instrumental delivery. Males had a lower LDL, but no other markers of insulin resistance or metabolic function were affected by fetal sex. Women with obesity had elevated markers of insulin resistance and metabolic dysfunction compared with women that were overweight, but maternal BMI did not impact these variables in the fetus. Fetal sex did not impact maternal and fetal metabolic parameters in women with BMI > 25 kg/m2. However, a higher BMI caused increasingly deranged maternal blood lipid concentrations and markers of insulin resistance as pregnancy progressed. Lipid monitoring and interventions to reduce lipids during pregnancy therefore require further evaluation.

Cost-effectiveness of a mobile health-supported lifestyle intervention for pregnant women with an elevated body mass index.

OBJECTIVE: To assess the cost-effectiveness of a mobile health-supported lifestyle intervention compared with usual care. METHODS: We conducted a cost-effectiveness analysis from the perspective of the publicly-funded health care system. We estimated costs associated with the intervention and health care utilisation from first antenatal care appointment through delivery. We used bootstrap methods to quantify the uncertainty around cost-effectiveness estimates. Health outcomes assessed in this analysis were gestational weight gain (GWG; kg), incidence of excessive GWG, quality-adjusted life years (QALYs), and incidence of large-for-gestational-age (LGA). Incremental cost-effectiveness ratios (ICERs) were calculated as cost per QALY gained, cost per kg of GWG avoided, cost per case of excessive GWG averted, and cost per case of LGA averted. RESULTS: Total mean cost including intervention and health care utilisation was €3745 in the intervention group and €3471 in the control group (mean difference €274, P = 0.08). The ICER was €2914 per QALY gained. Assuming a ceiling ratio of €45,000, the probability that the intervention was cost-effective based on QALYs was 79%. Cost per kg of GWG avoided was €209. The cost-effectiveness acceptability curve (CEAC) for kg of GWG avoided reached a confidence level of 95% at €905, indicating that if one is willing to pay a maximum of an additional €905 per kg of GWG avoided, there is a 95% probability that the intervention is cost-effective. Costs per case of excessive GWG averted and case of LGA averted were €2117 and €5911, respectively. The CEAC for case of excessive GWG averted and for case of LGA averted reached a confidence level of 95% at €7090 and €25,737, respectively. CONCLUSIONS: Results suggest that a mobile-health lifestyle intervention could be cost-effective; however, a better understanding of the short- and long-term costs of LGA and excessive GWG is necessary to confirm the results.

An observational analysis of meal patterns in overweight and obese pregnancy: exploring meal pattern behaviours and the association with maternal and fetal health measures.

BACKGROUND: Nutrient intakes are known to be poorer among pregnant women with raised body mass index (BMI) than those with a healthy BMI. While meal patterns have the potential to influence obstetric, metabolic and anthropometric measures for mother and infant, limited data exists regarding meal patterns among pregnant women with raised BMI. AIM: To identify categories of meal patterns among pregnant women with overweight and obesity and determine whether patterns change with advancing gestation. To determine if maternal meal patterns are associated with dietary intakes and pregnancy outcomes. METHODS: Prospective, observational analysis of pregnant women (n = 143) (BMI 25-39.9 kg/m2). Meal pattern data were analysed from 3-day food diaries at 16 and 28 weeks' gestation. Outcomes include maternal blood glucose, insulin resistance, gestational diabetes, gestational weight gain and infant anthropometry. RESULTS: Three meal pattern categories were identified: 'main meal dominant' (3 main eating occasions + 0-3 snacks), 'large meal dominant' (≤ 2 main eating occasions + < 2 snacks), and 'snack dominant' (3 main eating occasions + > 3 snacks and ≤ 2 main + ≥ 2 snacks). A main meal-dominant pattern prevailed at 16 weeks' (85.3%) and a snack-dominant pattern at 28 weeks' (68.5%). Dietary glycaemic index was lower among the main meal versus large meal-dominant pattern at 28 weeks (P = 0.018). Infant birth weight (kg) and macrosomia were highest among participants with a large meal-dominant pattern at 28 weeks (P = 0.030 and P = 0.008, respectively). CONCLUSION: Women with raised BMI changed eating patterns as pregnancy progressed, moving from main meal-dominant to snack-dominant patterns. Large meal-dominant meal patterns in later pregnancy were associated with higher glycaemic index and greater prevalence of macrosomia.

Nutrition, Behavior Change and Physical Activity Outcomes From the PEARS RCT-An mHealth-Supported, Lifestyle Intervention Among Pregnant Women With Overweight and Obesity.

Background: Diet quality and physical activity positively impact pregnancy outcomes among women with obesity, but successful lifestyle interventions require intense clinician time. We aimed to investigate the impact of a behavioral-lifestyle intervention (PEARS) supported by a smartphone app among pregnant women with overweight and obesity, on nutrient intake, behavioral stage-of-change and physical activity. Methods: Pregnant women (BMI 25-39.9 kg/m2, measured, n = 565) were randomized at 15.6 weeks' gestation to the intervention (n = 278), or a control group (n = 287) (ISRCTN29316280). The intervention was grounded in behavior-change theory. Participants received nutrition (low glycaemic index and healthy eating) and exercise advice, a smartphone app and fortnightly emails. The control group received usual care which does not include dietary advice. At baseline and 28 weeks' gestation, dietary data were obtained through 3-day food diaries (n = 290 matched), and stage-of-change and physical activity data were self-reported. App usage data were collected. Results: There were no differences between the groups at baseline. Compared with the control group, the intervention group had improved dietary intakes post-intervention with; lower glycaemic index (MD -1.75); free sugars (%TE) (MD -0.98); fat (%TE) (MD -1.80); and sodium (mg) (MD -183.49). Physical activity (MET-minutes/week) was higher in the intervention group post-intervention (MD 141.4; 95% CI 62.9, 219.9). The proportion of participants at "maintenance" stage-of-change for physical activity was higher in the intervention group (56.3 vs. 31.2%). App use was associated with lower glycaemic index and less energy from free sugars, but not with physical activity. Conclusion: A behavioral-lifestyle intervention in pregnancy supported by a smartphone app improved dietary intakes, physical activity, and motivation to engage in exercise.

Pregnancy Exercise and Nutrition With Smartphone Application Support: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of a healthy lifestyle package (an antenatal behavior change intervention supported by smartphone application technology) on the incidence of gestational diabetes mellitus (GDM) in overweight and obese women. METHODS: Women with body mass indexes (BMIs) 25-39.9 were enrolled into this randomized controlled trial. The intervention consisted of specific dietary and exercise advice that addressed behavior change supported by a tailor-designed smartphone application. Women in the control group received usual care. The primary outcome was the incidence of GDM at 28-30 weeks of gestation. To reduce GDM from 15% to 7.2%, we estimated that 506 women would be required to have 80% power to detect this effect size at a significance of .05, that is, 253 in each group. RESULTS: Between March 2013 and February 2016, 565 women were recruited with a mean BMI of 29.3 and mean gestational age of 15.5 weeks. The incidence of GDM did not differ between the two groups, 37 of 241 (15.4%) in the intervention group compared with 36 of 257 (14.1%) in the control group (relative risk 1.1, 95% CI 0.71-1.66, P=.71). CONCLUSIONS: A mobile health-supported behavioral intervention did not decrease the incidence of GDM. CLINICAL TRIAL REGISTRATION: ISRCTN registry, https://www.isrctn.com/, ISRCTN29316280.

Maternal metabolic response to dietary treatment for impaired glucose tolerance and gestational diabetes mellitus.

BACKGROUND: Dietary advice is a standard component of treatment for pregnant women with impaired glucose tolerance (IGT) and gestational diabetes (GDM), yet few studies report glycemic profiles in response to dietary therapies and the optimal dietary approach remains uncertain. AIM: To assess changes in maternal glycemic profile and pregnancy outcomes among women with diet-controlled IGT and GDM. METHODS: Pregnant women who had one or more elevated values on a 3-h oral glucose tolerance test were enrolled. All participants received dietary advice and glucose monitoring as part of routine clinical care. Fasting and 1-h post-prandial blood samples, collected prior to initiation of clinical treatment and repeated 4-6 weeks later, were analyzed for glucose, insulin, and C-peptide. Homeostasis model assessment of insulin resistance (HOMA-IR) was calculated. Women who required pharmacological therapy for glucose control were excluded from analyses. RESULTS: Participants (N = 93) were of moderately older age (mean 33 years), with a high rate of overweight/obesity (mean body mass index (BMI) = 28.65 kg/m2), and were diagnosed late in gestation (mean 29 weeks). Fasting (mean ± SD 4.82 ± 0.53 to 4.60 ± 0.42 mmol/l; p < 0.001) and post-prandial glucose (7.01 ± 1.19 to 6.47 ± 1.10; p = 0.004) decreased significantly following the intervention. Baseline HOMA-IR was elevated (3.12 ± 1.03) but did not significantly decrease (2.78 ± 1.52; p = 0.066). There were high rates of macrosomia (24.7%) and cesarean delivery (32.3%). CONCLUSIONS: Although improvements in blood glucose levels were observed among women with diet-controlled IGT and GDM, this was insufficient to significantly affect insulin resistance or perinatal outcome. Late diagnosis and treatment of IGT/GDM may have contributed to such outcomes.

Influences on the food choices and physical activity behaviours of overweight and obese pregnant women: A qualitative study.

OBJECTIVE: to qualitatively explore influences identified by overweight/obese pregnant women on food choices and physical activity (PA) behaviours; to determine the impact of pregnancy on these factors; and to inform development of future lifestyle interventions during pregnancy. DESIGN: cross-sectional interview study. SETTING: maternity hospital, Ireland. PARTICIPANTS: pregnant women (n=22), early pregnancy Body Mass Index > 25kg/m2 MEASURES: barriers to and facilitators of healthy eating and PA in overweight/obese pregnancy. Interviews were transcribed verbatim and analysed using inductive thematic analysis. FINDINGS: overweight/obese women perceived the following factors to influence their food choices and PA behaviours: personal (e.g. age, enjoyment, health, aesthetic appearance, and response to fatigue); social (e.g. social support, food modelling, social facilitation and weight bias) and environmental (e.g. food salience and the obesogenic environment). These factors affected PA and food choice trajectories differently according to socio-economic and socio-cultural context. CONCLUSION AND IMPLICATIONS: personal, social and environmental factors affect food choices and PA behaviours. Pregnancy is a powerful stimulus for positive changes in food choices particularly. This change is driven by desire for healthy pregnancy outcome, and is not intrinsically motivated. Healthy lifestyle interventions should aim to sustain positive changes beyond pregnancy through: empowerment, intrinsic motivation, family-centred approach, and behavioural goals.

Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.

OBJECTIVE: Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population. METHODS: We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference. CONCLUSION: This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM.

Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial.

OBJECTIVE: Probiotics are live microorganisms that may confer health benefits on the host. Recent trials of probiotic use among healthy pregnant women demonstrate potential for improved glycemic control. The aim of this study was to investigate the effects of a probiotic capsule intervention on maternal metabolic parameters and pregnancy outcome among women with gestational diabetes. STUDY DESIGN: This double-blind placebo-controlled randomized trial recruited pregnant women with a new diagnosis of gestational diabetes or impaired glucose tolerance following a 3-hour 100-g glucose tolerance test. Women were randomized to a daily probiotic (Lactobacillus salivarius UCC118) or placebo capsule from diagnosis until delivery. Fasting blood samples were collected at baseline and 4-6 weeks after capsule commencement for analysis of glucose, insulin, c-peptide, and lipids. The primary outcome was difference in fasting glucose postintervention, first analyzed on an intention-to-treat basis and followed by per-protocol analysis that excluded women commenced on pharmacological therapy (insulin or metformin). Secondary outcomes were changes in insulin, c-peptide, homeostasis model assessment and lipids, requirement for pharmacological therapy, and neonatal anthropometry. RESULTS: Of 149 women recruited and randomized, there were no differences between the probiotic and placebo groups in postintervention fasting glucose (4.65 ± 0.49 vs 4.65 ± 0.53 mmol/L; P = 373), requirement for pharmacological therapy (17% vs 14%; P = .643), or birthweight (3.57 ± 0.64 vs 3.60 ± 0.57 kg; P = .845). Among 100 women managed with diet and exercise alone, fasting plasma glucose decreased significantly within both the probiotic (4.76 ± 0.45 to 4.57 ± 0.42 mmol/L; P < .001) and placebo (4.85 ± 0.58 to 4.58 ± 0.45 mmol/L; P < .001) groups, but the levels between groups did not differ (P = .316). The late gestation-related rise in total and low-density lipoprotein (LDL) cholesterol was attenuated in the probiotic vs the placebo group (+0.27 ± 0.48 vs +0.50 ± 0.52 mmol/L total cholesterol, P = .031; +0.08 ± 0.51 vs +0.31 ± 0.45 mmol/L LDL cholesterol, P = .011). No differences were noted between groups in other metabolic parameters or pregnancy outcome. CONCLUSION: A probiotic capsule intervention among women with abnormal glucose tolerance had no impact on glycemic control. The observed attenuation of the normal pregnancy-induced rise in total and LDL cholesterol following probiotic treatment requires further investigation, particularly in this obstetric group at risk of future metabolic syndrome.

Probiotics in obese pregnancy do not reduce maternal fasting glucose: a double-blind, placebo-controlled, randomized trial (Probiotics in Pregnancy Study).

BACKGROUND: Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women. Obesity significantly increases risk of impaired glucose tolerance in pregnancy, but glycemic effects of probiotics in this specific obstetric group require additional investigation. OBJECTIVE: The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women. DESIGN: In this placebo-controlled, double-blind, randomized trial, 175 pregnant women with an early pregnancy body mass index (BMI; in kg/m²) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital, Dublin, Ireland. Exclusion criteria were BMI <30.0 or >39.9, prepregnancy or gestational diabetes, age <18 y, multiple pregnancy, and fetal anomaly. Women were randomly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care. The primary outcome was the change in fasting glucose between groups from preintervention to postintervention. Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures. RESULTS: In 138 women who completed the study (63 women in the probiotic group; 75 women in the placebo group), mean (±SD) early pregnancy BMI was 33.6 ± 2.6, which differed significantly between probiotic (32.9 ± 2.4) and placebo (34.1 ± 2.7) groups. With adjustment for BMI, the change in maternal fasting glucose did not differ significantly between treated and control groups [-0.09 ± 0.27 compared with -0.07 ± 0.39 mmol/L; P = 0.391; B = -0.05 (95% CI: -0.17, 0.07)]. There were also no differences in the incidence of impaired glycemia (16% in the probiotic group compared with 15% in the placebo group; P = 0.561), birth weight (3.70 kg in the probiotic group compared with 3.68 kg in the placebo group; P = 0.723), or other metabolic variables or pregnancy outcomes. A secondary analysis of 110 women, excluding antibiotic users and poor compliers, also revealed no differences in maternal glucose or other outcomes between groups. CONCLUSION: Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose, the metabolic profile, or pregnancy outcomes in obese women.