Periodic mobile application (eMOM) with self-tracking of glucose and lifestyle improves treatment of diet-controlled gestational diabetes without human guidance: a randomized controlled trial.

BACKGROUND: Digitalization with minimal human resources could support self-management among women with gestational diabetes and improve maternal and neonatal outcomes. OBJECTIVE: This study aimed to investigate if a periodic mobile application (eMOM) with wearable sensors improves maternal and neonatal outcomes among women with diet-controlled gestational diabetes without additional guidance from healthcare personnel. STUDY DESIGN: Women with gestational diabetes were randomly assigned in a 1:1 ratio at 24 to 28 weeks' gestation to the intervention or the control arm. The intervention arm received standard care in combination with use of the periodic eMOM, whereas the control arm received only standard care. The intervention arm used eMOM with a continuous glucose monitor, an activity tracker, and a food diary 1 week/month until delivery. The primary outcome was the change in fasting plasma glucose from baseline to 35 to 37 weeks' gestation. Secondary outcomes included capillary glucose, weight gain, nutrition, physical activity, pregnancy complications, and neonatal outcomes, such as macrosomia. RESULTS: In total, 148 women (76 in the intervention arm, 72 in the control arm; average age, 34.1±4.0 years; body mass index, 27.1±5.0 kg/m2) were randomized. The intervention arm showed a lower mean change in fasting plasma glucose than the control arm (difference, -0.15 mmol/L vs -2.7 mg/mL; P=.022) and lower capillary fasting glucose levels (difference, -0.04 mmol/L vs -0.7 mg/mL; P=.002). The intervention arm also increased their intake of vegetables (difference, 11.8 g/MJ; P=.043), decreased their sedentary behavior (difference, -27.3 min/d; P=.043), and increased light physical activity (difference, 22.8 min/d; P=.009) when compared with the control arm. In addition, gestational weight gain was lower (difference, -1.3 kg; P=.015), and there were less newborns with macrosomia in the intervention arm (difference, -13.1 %; P=.036). Adherence to eMOM was high (daily use >90%), and the usage correlated with lower maternal fasting (P=.0006) and postprandial glucose levels (P=.017), weight gain (P=.028), intake of energy (P=.021) and carbohydrates (P=.003), and longer duration of the daily physical activity (P=.0006). There were no significant between-arm differences in terms of pregnancy complications. CONCLUSION: Self-tracking of lifestyle factors and glucose levels without additional guidance improves self-management and the treatment of gestational diabetes, which also benefits newborns. The results of this study support the use of digital self-management and education tools in maternity care.

Associations Between Sedentary Time, Physical Activity, and Cardiovascular Health in 6-Year-Old Children Born to Mothers With Increased Cardiometabolic Risk.

PURPOSE: To assess associations between sedentary time (ST), physical activity (PA), and cardiovascular health in early childhood. METHOD: Cross-sectional study including 160 children (age 6.1 y [SD 0.5], 86 boys, 93 maternal body mass index ≥ 30 kg/m2, and 73 gestational diabetes) assessed for pulse wave velocity, echocardiography, ultra-high frequency 48-70 MHz vascular ultrasound, and accelerometery. RESULTS: Boys had 385 (SD 53) minutes per day ST, 305 (SD 44) minutes per day light PA, and 81 (SD 22) minutes per day moderate to vigorous PA (MVPA). Girls had 415 (SD 50) minutes per day ST, 283 (SD 40) minutes per day light PA, and 66 (SD 19) minutes per day MVPA. In adjusted analyses, MVPA was inversely associated with resting heart rate (ß = -6.6; 95% confidence interval, -12.5 to -0.7) and positively associated with left ventricular mass (ß = 6.8; 1.4-12.3), radial intima-media thickness (ß = 11.4; 5.4-17.5), brachial intima-media thickness (ß = 8.0; 2.0-14.0), and femoral intima-media thickness (ß = 1.3; 0.2-2.3). MVPA was inversely associated with body fat percentage (ß = -3.4; -6.6 to -0.2), diastolic blood pressure (ß = -0.05; -0.8 to -0.1), and femoral (ß = -18.1; -32.4 to -0.8) and radial (ß = -13.4; -24.0 to -2.9) circumferential wall stress in boys only. ST and pulse wave velocity showed no significant associations. CONCLUSIONS: In young at-risk children, MVPA is associated with cardiovascular remodeling, partly in a sex-dependant way, likely representing physiological adaptation, but ST shows no association with cardiovascular health in early childhood.

Early ascending growth is associated with maternal lipoprotein profile during mid and late pregnancy and in cord blood.

INTRODUCTION: Intrauterine conditions and accelerating early growth are associated with childhood obesity. It is unknown, whether fetal programming affects the early growth and could alterations in the maternal-fetal metabolome be the mediating mechanism. Therefore, we aimed to assess the associations between maternal and cord blood metabolite profile and offspring early growth. METHODS: The RADIEL study recruited 724 women at high risk for gestational diabetes mellitus (GDM) BMI ≥ 30 kg/m2 and/or prior GDM) before or in early pregnancy. Blood samples were collected once in each trimester, and from cord. Metabolomics were analyzed by targeted nuclear magnetic resonance (NMR) technique. Following up on offsprings' first 2 years growth, we discovered 3 distinct growth profiles (ascending n = 80, intermediate n = 346, and descending n = 146) by using latent class mixed models (lcmm). RESULTS: From the cohort of mother-child dyads with available growth profile data (n = 572), we have metabolomic data from 232 mothers from 1st trimester, 271 from 2nd trimester, 277 from 3rd trimester and 345 from cord blood. We have data on 220 metabolites in each trimester and 70 from cord blood. In each trimester of pregnancy, the mothers of the ascending group showed higher levels of VLDL and LDL particles, and lower levels of HDL particles (p < 0.05). When adjusted for gestational age, birth weight, sex, delivery mode, and maternal smoking, there was an association with ascending profile and 2nd trimester total cholesterol in HDL2, 3rd trimester total cholesterol in HDL2 and in HDL, VLDL size and ratio of triglycerides to phosphoglycerides (TG/PG ratio) in cord blood (p ≤ 0.002). CONCLUSION: Ascending early growth was associated with lower maternal total cholesterol in HDL in 2nd and 3rd trimester, and higher VLDL size and more adverse TG/PG ratio in cord blood. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://www. CLINICALTRIALS: com , NCT01698385.

Genetic risk of type 2 diabetes modifies the effects of a lifestyle intervention aimed at the prevention of gestational and postpartum diabetes.

AIMS/HYPOTHESIS: The aim of this study was to assess the interaction between genetic risk and lifestyle intervention on the occurrence of gestational diabetes mellitus (GDM) and postpartum diabetes. METHODS: The RADIEL study is an RCT aimed at prevention of GDM and postpartum diabetes through lifestyle intervention. Participants with a BMI ≥30 kg/m2 and/or prior GDM were allocated to intervention and control groups before pregnancy or in early pregnancy. The study visits took place every 3 months before pregnancy, once in each trimester, and at 6 weeks and 6 and 12 months postpartum. We calculated a polygenic risk score (PRS) based on 50 risk variants for type 2 diabetes. RESULTS: Altogether, 516 participants provided genetic and GDM data. The PRS was associated with higher glycaemic levels (fasting glucose and/or HbA1c) and a lower insulin secretion index in the second and third trimesters and at 12 months postpartum, as well as with a higher occurrence of GDM and glycaemic abnormalities at 12 months postpartum (n = 356). There was an interaction between the PRS and lifestyle intervention (p=0.016 during pregnancy and p=0.024 postpartum) when analysing participants who did not have GDM at the first study visit during pregnancy (n = 386). When analysing women in tertiles according to the PRS, the intervention was effective in reducing the age-adjusted occurrence of GDM only among those with the highest genetic risk (OR 0.37; 95% CI 0.17, 0.82). The risk of glycaemic abnormalities at 12 months postpartum was reduced in the same group after adjusting additionally for BMI, parity, smoking and education (OR 0.35; 95% CI 0.13, 0.97). CONCLUSIONS/INTERPRETATION: Genetic predisposition to diabetes modifies the response to a lifestyle intervention aimed at prevention of GDM and postpartum diabetes. This suggests that lifestyle intervention may benefit from being tailored according to genetic risk. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01698385.

Physical activity and health-related quality of life among high-risk women for type 2 diabetes in the early years after pregnancy.

BACKGROUND: Previous studies have shown that physical activity (PA) correlates positively with health-related quality of life (HRQoL) in the general population. Few studies have investigated associations between device-measured PA and HRQoL among premenopausal women at risk for type 2 diabetes (T2D). In addition to physical well-being, general well-being improved by PA has been suggested to strengthen PA's benefits in reducing metabolic diseases. The aim of this study was to examine the associations between PA and HRQoL (general and dimensions) among high-risk women in the early post-pregnancy years when T2D risk is highest and to estimate whether current obesity or prior gestational diabetes (GDM) modified these associations. METHODS: This cross-sectional study of high-risk women [body mass index (BMI) ≥ 30 kg/m2 and/or prior GDM)]4-6 years after delivery measured sleep, sedentary time, daily steps, and light (LPA), moderate-to-vigorous (MVPA), and vigorous PA (VPA) with the SenseWear ArmbandTM accelerometer for seven days and HRQoL with the 15D instrument. RESULTS: The analyses included 204 women with a median (IQR) age of 39 (6.0) years and a median BMI of 31.1 kg/m2 (10.9). 54% were currently obese (BMI ≥ 30 kg/m2), and 70% had prior gestational diabetes (GDM+). Women with obesity had lower PA levels than women with normal weight or overweight (p < 0.001) but there was no difference between the GDM+ or GDM- women. Women with both current obesity and GDM+ had highest sedentary time and lowest PA levels. The whole sample's median 15D score was 0.934 (IQR 0.092), lower among women with obesity compared to the others (p < 0.001), but not different between GDM+ or GDM-. There was a positive correlation between VPA (adjusted rs = 0.262 p = 0.001) and the 15D score. After grouping according to BMI (< and ≥ 30 kg/m2), the associations remained significant only in women without obesity. Among them, sleep, total steps, MVPA, and VPA were positively associated with 15D. CONCLUSIONS: Higher PA levels are associated with better HRQoL among high-risk women with normal weight and overweight but no differences were found among women affected by obesity in the early years after pregnancy. Trial registration Ethics committees of Helsinki University Hospital (Dnro 300/e9/06) and South Karelian Central Hospital (Dnro 06/08).

Bone health in women with a history of gestational diabetes or obesity.

INTRODUCTION: Type 2 diabetes is associated with an increased risk of bone fractures. However, bone health of women with a history of gestational diabetes (GDM) has received little attention. This cross-sectional study compares bone health between premenopausal women with and without a history of GDM, and examines factors associated with bone health in women with a history of GDM or obesity. MATERIAL AND METHODS: We measured areal bone mineral density for total hip, lumbar spine and whole body, and total body fat percentage (fat%) with dual-energy X-ray absorptiometry in 224 women. In addition, we measured bone characteristics of radius and tibia with peripheral quantitative computed tomography. RESULTS: When compared with women without a history of GDM (mean age 39 years [SD 5], body mass index [BMI] 35 kg/m2 [SD 6], fat% 48 [SD 7]), women with a history of GDM (age 41 years [SD 4], BMI 31 kg/m2 [SD 7], fat% 43 [SD 10]) had lower hip and whole body bone mineral densities, and inferior tibia outcomes. However, the differences in bone characteristics disappeared after controlling for age, height, BMI and fat%. After controlling for age, height, BMI and smoking, physical activity and healthier diet were positively associated with bone outcomes, whereas fat%, HbA1c and screen time were negatively associated with bone outcomes. Particularly, fat% showed independent negative associations with whole body bone mineral density and several tibia and radius characteristics. CONCLUSIONS: Fat% is associated with adverse bone health, independently of BMI, in women with a history of GDM or obesity. Promoting healthy lifestyle and reducing fat% in high-risk women could improve bone health and prevent future fractures.

Effect of lifestyle counselling on health-related quality of life in women at high risk for gestational diabetes.

BACKGROUND: The incidence of gestational diabetes (GDM) is increasing and interventions to curb the detrimental effects of GDM are needed. We have previously reported that a combined diet and physical activity intervention has the potential to reduce GDM among high-risk women. It is also important to know whether the intervention affects health-related quality of life (HRQoL). METHODS: A total of 378 women at high risk for GDM were randomized into an intervention (lifestyle counselling four times during pregnancy, n=192), or a control group (n=186) before 20 gestational weeks. HRQoL was assessed with the 15D-instrument six times: once during each trimester and at six weeks, six months and 12 months postpartum. RESULTS: In this study population, the cumulative incidence of GDM was similar in the intervention and the control group (45.7 vs. 44.5%). There was no difference between the 15D scores of the control and intervention groups at any of the time points. CONCLUSIONS: Combined diet and physical activity intervention did not provide HRQoL benefits in the study. A high prevalence of GDM in both study groups may have confounded the effect of the intervention.

Long-term effects of a preconception lifestyle intervention on cardiometabolic health of overweight and obese women.

BACKGROUND: The global prevalence of obesity in women keeps increasing. The preconception period may be a window of opportunity to improve lifestyle, reduce obesity and improve cardiometabolic health. This study assessed the effect of a preconception lifestyle intervention on long-term cardiometabolic health in two randomized controlled trials (RCTs). METHODS: Participants of the LIFEstyle and RADIEL preconception lifestyle intervention studies with a baseline body mass index (BMI) ≥29 kg/m2 were eligible for this follow-up study. Both studies randomized between a lifestyle intervention targeting physical activity, diet and behaviour modification or usual care. We assessed cardiometabolic health 6 years after randomization. RESULTS: In the LIFEstyle study (n = 111) and RADIEL study (n = 39), no statistically significant differences between the intervention and control groups were found for body composition, blood pressure, arterial stiffness, fasting glucose, homeostasis model assessment of insulin resistance, HbA1c, lipids and high sensitive C-reactive protein levels 6 years after randomization. Participants of the LIFEstyle study who successfully lost ≥5% bodyweight or reached a BMI <29 kg/m2 during the intervention (n = 22, [44%]) had lower weight (-8.1 kg; 99% CI [-16.6 to -0.9]), BMI (-3.3 kg/m2; [-6.5 to -0.8]), waist circumference (-8.2 cm; [-15.3 to -1.3]), fasting glucose (-0.5 mmol/L; [-1.1 to -0.0]), HbA1c (-4.1 mmol/mol; [-9.1 to -0.8]), and higher HDL-C (0.3 mmol/L; [0.1-0.5]) compared with controls. CONCLUSION: We found no evidence of improved cardiometabolic health 6 years after a preconception lifestyle intervention among overweight and obese women in two RCTs. Women who successfully lost weight during the intervention had better cardiometabolic health 6 years later, emphasizing the potential of successful preconception lifestyle improvement.

Effects of maternal lifestyle interventions on child neurobehavioral development: Follow-up of randomized controlled trials.

Obesity is a major public health problem. Children of women who were obese before or during pregnancy are at increased risk for neurobehavioral developmental problems. Whether a maternal lifestyle intervention conducted before and during pregnancy in obese women affects child neurobehavioral development is unknown. This study reports on the follow-up of a subsample of two randomized controlled trials, the Finnish RADIEL (n = 216) and Dutch LIFEstyle (n = 305) trial. Women with a pre-pregnancy BMI ≥29 kg/m2 wishing to conceive or who were already pregnant (<20 weeks) were allocated to a lifestyle intervention or to care as usual. Child neurodevelopment was measured with the Ages and Stages Questionnaire and child behavioral problems were measured with the Childhood Behavior Checklist (RADIEL) or the Strengths and Difficulties Questionnaire (LIFEstyle) at age 3-6 years. We used linear and binary logistic regression analyses to assess the effects of the lifestyle interventions on children's neurobehavioral developmental scores. Follow-up data was available from 161(38%) RADIEL and 96(32%) LIFEstyle children. Child neurodevelopmental scores did not differ significantly between children in the intervention and the control group (RADIEL:median = 275 vs. 280; LIFEstyle:median = 270 vs 267). Child behavioral problem scores did not differ significantly between children in the intervention and the control group (RADIEL:median = 22 vs. 21; LIFEstyle:median = 8 vs. 8). We did not observe considerable effects of the lifestyle interventions before or during pregnancy in obese women on child neurobehavioral development. With our sample sizes, we were not able to detect subtle differences in neurobehavioral development however.

Diet quality as assessed by the Healthy Food Intake Index and relationship with serum lipoprotein particles and serum fatty acids in pregnant women at increased risk for gestational diabetes.

The importance of overall diet in modifying circulating lipoprotein particles and fatty acids during pregnancy is unclear. We examined the relationships of diet quality as assessed by the validated Healthy Food Intake Index (HFII) with serum HDL, LDL and VLDL particle concentrations and sizes and proportions of serum fatty acids in pregnant women at high risk for gestational diabetes mellitus (GDM). Overall, 161 women with a BMI of ≥30 kg/m2 and/or a history of GDM were drawn from the Finnish Gestational Diabetes Prevention Study, which is a dietary and exercise intervention trial to prevent GDM. At baseline, the HFII score was inversely related to concentrations of HDL particles (P=0·010) and MUFA (P=0·010) and positively related to concentrations of n-3 (P<0·001) and n-6 (P=0·003) PUFA. The significance for MUFA disappeared after adjustments. An increase in the HFII score from the first to second trimester of pregnancy correlated with reduced VLDL particle size (r -0·16, 95 % CI -0·31, -0·01), decreased MUFA concentrations (r -0·17, 95 % CI -0·31, -0·01) and elevated n-6 PUFA concentrations (r 0·16, 95 % CI 0·01, 0·31). In the maximum-adjusted model, the results remained significant except for VLDL particle size. These findings suggest that higher diet quality as defined by the HFII is related to a more favourable serum fatty acid profile, whereas the relationship with serum lipoprotein profile is limited in pregnant women at increased GDM risk.

Gut microbiome in gestational diabetes: a cross-sectional study of mothers and offspring 5 years postpartum.

INTRODUCTION: An altered gut microbiome composition is shown to be associated with various diseases and health outcomes. We compare the gut microbiota of women who developed gestational diabetes mellitus (GDM) with that of those who did not, and the gut microbiota of their offspring, to determine any differences in the composition and diversity of their gut microbiota, which may be correlated with their GDM state. MATERIAL AND METHODS: All women were at high risk for GDM and participated in the Finnish Gestational Diabetes Prevention Study (RADIEL). Stool samples were obtained, 5 years postpartum, from 60 GDM-positive women, 68 non-GDM control women, and their children (n = 109), 237 individuals in total. 16S ribosomal RNA gene sequencing was employed to determine the composition of bacterial communities present. Statistical correlations were inferred between clinical variables and microbiota, while taking into account potential confounders. RESULTS: In mothers, no significant differences were observed in microbiota composition between the two groups. Genus Anaerotruncus was increased in children of women with GDM (p < 0.001). Beta-diversity measures showed that a mother and her child have a more similar microbiome composition when compared with unrelated children, other mothers, or the children compared with each other (p < 0.001). CONCLUSIONS: These results suggest that there may be no discernible microbiome basis to GDM susceptibility in high-risk women, whereas microbiome differences between the offspring could be of greater biological significance. The heterogeneous nature of the disease could be obscuring potential differences between women. A longer time-series study, with carefully defined subject subgroups, may be an appropriate course of future investigation into GDM and the microbiome.

Is improvement in the Healthy Food Intake Index (HFII) related to a lower risk for gestational diabetes?

The aim was to analyse whether changes in the Healthy Food Intake Index (HFII) during pregnancy are related to gestational diabetes (GDM) risk. The 251 pregnant women participating had a pre-pregnancy BMI≥30 kg/m2 and/or a history of GDM. A 75 g oral glucose tolerance test (OGTT) was performed during the first and second trimesters of pregnancy for assessment of GDM. A normal OGTT result at first trimester was an inclusion criterion for the study. FFQ collected at first and second trimesters served for calculating the HFII. A higher HFII score reflects higher adherence to the Nordic Nutrition Recommendations (NNR) (score range 0-17). Statistical methods included Student's t test, Mann-Whitney U test, Fisher's exact test and linear and logistic regression analyses. The mean HFII at first trimester was 10·1 (95 % CI 9·7, 10·4) points, and the mean change from the first to the second trimester was 0·35 (95 % CI 0·09, 0·62) points. The range of the HFII changes varied from -7 to 7. The odds for GDM decreased with higher HFII change (adjusted OR 0·83 per one unit increase in HFII; 95 % CI 0·69, 0·99; P=0·043). In the analysis of the association between HFII-sub-indices and GDM, odds for GDM decreased with higher HFII-Fat change (fat percentage of milk and cheese, type of spread and cooking fats) but it was not significant in a fully adjusted model (P=0·058). Dietary changes towards the NNR during pregnancy seem to be related to a lower risk for GDM.

"The Burden of Pregnancy"; heavier for the heaviest? The changes in Health Related Quality of Life (HRQoL) assessed by the 15D instrument during pregnancy and postpartum in different body mass index groups: a longitudinal survey.

INTRODUCTION: Only little information is available on health-related quality of life (HRQoL) and its changes during the course of a normal pregnancy. We studied changes in HRQoL in a pregnant population during pregnancy and until 1 year postpartum in different body mass index (BMI) groups. MATERIAL AND METHODS: Seven hundred and fifty pregnant women attending the first ultrasound examination before gestational week 14 were invited to participate in a longitudinal, communal-based survey. The participants were divided into three groups according to their BMI; <25, 25-29.9, and ≥30 kg/m2 . The women were asked to fill in questionnaires assessing HRQoL (15D), depressive symptoms (Edinburgh Depression Scale, EPDS), medical, obstetric and socioeconomic status at baseline. HRQoL and EPDS were re-assessed at 30 weeks of gestation, and 6 weeks, 3 and 12 months postpartum. RESULTS: Of the invited 750 mothers, 325 (43%) returned the questionnaires and at least one follow-up questionnaire. At baseline, mean 15D scores decreased with increasing BMI but the difference was not statistically significant when adjusted for age, educational attainment, parity or EPDS-scores (0.929, 0.921 and 0.916, p = 0.16). During the course of pregnancy, the HRQoL of all women decreased but this decrease was significantly greater in the obese group (-0.088; 95% CI -0.110 to -0.065) than in the other groups [-0.054 (95% CI -0.062 to -0.045) and -0.051 (95% CI -0.068 to -0.033), p = 0.019]. Within 3 months postpartum the mean HRQoL recovered in all BMI groups to baseline levels, irrespective of the mode of delivery or pregnancy-related complications. CONCLUSION: The burden of pregnancy is heavier for the heaviest.

Perceived Financial Satisfaction, Health Related Quality of Life and depressive Symptoms in Early Pregnancy.

Objectives To assess the associations of perceived financial satisfaction and health-related quality of life (HRQoL) and depressive symptoms in an unselected pregnant population in early pregnancy. Methods 750 consecutive pregnant women attending the first communal ultrasound examination before gestational week 14 were invited to participate. Questionnaires assessing HRQoL (15D), depressive symptoms (Edinburgh Depression Scale, EPDS), medical, obstetric, and socioeconomic status were handed out. The participants were divided into three groups according to their satisfaction with their financial status, (unsatisfied, somewhat satisfied, and satisfied). Main outcome measures were 15D and EPDS-scores and dimensions of HRQoL. Results 325 (43,3%) questionnaires were returned. The mean 15D-score for HRQoL was 0,926 (SD 0,056). The financially unsatisfied women had lower HRQoL than women in more satisfied groups (0.906, 0.923 and 0.931, p = 0.012). The result remained significant, even after adjusting for age and education(p = 0.032). The unsatisfied women had a higher mean body mass index (BMI) (25.4, 24.4 and 23.2 kg/m2, p for linearity = 0.002), were more often smokers, (13 vs. 4 and 3%, p = 0.029), and had experienced at least one abortion (18, 14 and 7%, p = 0.017). Dimensions of depression, distress and sleep explained the differences between the groups. 27% of unsatisfied women scored EPDS ≥10 points suggesting increased risk of depression. Conclusions Financial satisfaction in early pregnancy associates with HRQoL and risk of perinatal depressive symptoms. Unsatisfied women more often have risk factors for unfavourable pregnancy outcomes which may influence the later health and wellbeing of the mother and child.

Interaction between rs10830963 polymorphism in MTNR1B and lifestyle intervention on occurrence of gestational diabetes.

AIMS/HYPOTHESIS: The aim of this study was to assess the interaction between melatonin receptor 1B gene (MTNR1B) rs10830963 polymorphism and lifestyle intervention during pregnancy on occurrence of gestational diabetes mellitus (GDM) in high-risk women. METHODS: This is a secondary analysis of the randomised controlled gestational diabetes prevention trial 'RADIEL', conducted between 2008 and 2014 in four maternity hospitals in southern Finland. A total of 226 women with a history of GDM and/or a pre-pregnancy BMI ≥ 30 kg/m(2) were enrolled at <20 weeks of gestation (mean 13 weeks) and randomised into an intervention group receiving counselling on diet, physical activity and weight control and a control group receiving standard antenatal care. The main outcome was incidence of GDM, defined as one or more pathological glucose values in a standard 75 g 2-h OGTT. The MTNR1B rs10830963 was genotyped for further analyses. RESULTS: No significant differences were found in the genotype distribution between the intervention and the control group. A significant interaction was observed between the rs10830963 genotypes and the lifestyle intervention on age-adjusted occurrence of gestational diabetes (p = 0.038). Among women homozygous for the C allele of rs10830963, the OR for GDM was significantly lower in the intervention group than in the control group (OR 0.16 [95% CI 0.03, 0.85], p = 0.014). This difference was not seen in women heterozygous (OR 0.88 [95% CI 0.32, 2.41], p = 0.798) or homozygous (OR 2.25 [95% CI 0.34, 14.69], p = 0.384) for the risk allele G. CONCLUSIONS/INTERPRETATION: In women at high risk of GDM, only those not carrying the risk allele G benefited from the lifestyle intervention. Our results indicate that certain genetic risk variants may modify the effectiveness of lifestyle interventions. This may provide important information when planning GDM prevention studies in the future.

Healthy Food Intake Index (HFII) - Validity and reproducibility in a gestational-diabetes-risk population.

BACKGROUND: The aim was to develop and validate a food-based diet quality index for measuring adherence to the Nordic Nutrition Recommendations (NNR) in a pregnant population with high risk of gestational diabetes (GDM). METHODS: This study is a part of the Finnish Gestational Diabetes Prevention Study (RADIEL), a lifestyle intervention conducted between 2008 and 2014. The 443 pregnant participants (61 % of those invited), were either obese or had a history of GDM. Food frequency questionnaires collected at 1st trimester served for composing the HFII; a sum of 11 food groups (available score range 0-17) with higher scores reflecting higher adherence to the NNR. RESULTS: The average HFII of the participants was 10.2 (SD 2.8, range 2-17). Factor analysis for the HFII component matrix revealed three factors that explained most of the distribution (59 %) of the HFII. As an evidence of the component relevance 9 out of 11 of the HFII components independently contributed to the total score (item-rest correlation coefficients <0.31). Saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, sucrose, and fiber intakes (among other nutrients) showed linearity across the HFII categories (P ≤ 0.030 for all nutrients tested); the higher the HFII, the closer the nutrient intake to the recommended intake level. Educational attainment (P = 0.0045), BMI (P = 0.0098), smoking (P = 0.007), and leisure time physical exercise (P = 0.038) showed linearity across the HFII categories. Intra-class correlation coefficient for the HFII was 0.85 (CI 0.79, 0.90). CONCLUSIONS: The HFII components reflect the food guidelines of the NNR, intakes of relevant nutrients, and characteristics known to vary with diet quality. It largely ignores energy intake, its components have independent contribution to the HFII, and it exhibits reproducibility. The main shortcomings are absence of red and processed meat component, and the validation in a selected study population. It is suitable for ranking participants according to the adherence to the NNR in pregnant women at high risk of GDM.

Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL).

BACKGROUND: Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences. METHODS: RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group. DISCUSSION: To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also provides an opportunity to focus upon the health of the next generation. The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age.

Metabolomic Profiles of Nonobese and Obese Women With Gestational Diabetes.

CONTEXT: In non-pregnant population, nonobese individuals with obesity-related metabolome have increased risk for type 2 diabetes and cardiovascular diseases. The risk of these diseases is also increased after gestational diabetes. OBJECTIVE: This work aimed to examine whether nonobese (body mass index [BMI] < 30) and obese (BMI ≥ 30) women with gestational diabetes mellitus (GDM) and obese non-GDM women differ in metabolomic profiles from nonobese non-GDM controls. METHODS: Levels of 66 metabolic measures were assessed in early (median 13, IQR 12.4-13.7 gestation weeks), and across early, mid (20, 19.3-23.0), and late (28, 27.0-35.0) pregnancy blood samples in 755 pregnant women from the PREDO and RADIEL studies. The independent replication cohort comprised 490 pregnant women. RESULTS: Nonobese and obese GDM, and obese non-GDM women differed similarly from the controls across early, mid, and late pregnancy in 13 measures, including very low-density lipoprotein-related measures, and fatty acids. In 6 measures, including fatty acid (FA) ratios, glycolysis-related measures, valine, and 3-hydroxybutyrate, the differences between obese GDM women and controls were more pronounced than the differences between nonobese GDM or obese non-GDM women and controls. In 16 measures, including HDL-related measures, FA ratios, amino acids, and inflammation, differences between obese GDM or obese non-GDM women and controls were more pronounced than the differences between nonobese GDM women and controls. Most differences were evident in early pregnancy, and in the replication cohort were more often in the same direction than would be expected by chance alone. CONCLUSION: Differences between nonobese and obese GDM, or obese non-GDM women and controls in metabolomic profiles may allow detection of high-risk women for timely targeted preventive interventions.

Ultra-high frequency ultrasound delineated changes in carotid and muscular artery intima-media and adventitia thickness in obese early middle-aged women.

Obesity is linked to increased arterial size, carotid intima-media thickness and arterial stiffness. The effects of obesity and body composition on muscular artery intima-media and adventitia thickness has previously not been established. The aim of this study was to explore associations between carotid and muscular artery wall layer thickness with body composition and cardiovascular risk factors in early middle-aged women. This is a cross-sectional study including 199 women aged 40±4 years. Arterial lumen (LD), intima-media (IMT) and adventitia thickness (AT) were measured from carotid, brachial and radial arteries using ultra-high frequency ultrasound (22-71 MHz). Women with obesity had increased IMT in carotid (0.47 vs 0.45 mm), brachial (0.19 vs 0.17 mm) and radial arteries (0.16 vs 0.15 mm) and increased brachial AT (0.14 vs 0.13 mm). In multiple regression models all arterial LD (ß-range 0.02-0.03 mm/kg/m2), IMT (ß-range 0.91-3.37 µm/kg/m2), AT (ß-range 0.73-1.38 µm/kg/m2) were significantly associated with BMI. The IMT of all arteries were significantly associated with systolic blood pressure (ß-range 0.36-0.85 µm/mmHg), attenuating the association between IMT and BMI (ß-range 0.18-2.24 µm/kg/m2). Obese early middle-aged women have increased arterial intima media thickness and brachial artery adventitia thickness compared to non-obese counterparts. The association between BMI and intima-media thickness is partly mediated through blood pressure levels.

Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study).

INTRODUCTION: Gestational diabetes (GDM) causes various adverse short-term and long-term consequences for the mother and child, and its incidence is increasing globally. So far, the most promising digital health interventions for GDM management have involved healthcare professionals to provide guidance and feedback. The principal aim of this study is to evaluate the effects of comprehensive and real-time self-tracking with eMOM GDM mobile application (app) on glucose levels in women with GDM, and more broadly, on different other maternal and neonatal outcomes. METHODS AND ANALYSIS: This randomised controlled trial is carried out in Helsinki metropolitan area. We randomise 200 pregnant women with GDM into the intervention and the control group at gestational week (GW) 24-28 (baseline, BL). The intervention group receives standard antenatal care and the eMOM GDM app, while the control group will receive only standard care. Participants in the intervention group use the eMOM GDM app with continuous glucose metre (CGM) and activity bracelet for 1 week every month until delivery and an electronic 3-day food record every month until delivery. The follow-up visit after intervention takes place 3 months post partum for both groups. Data are collected by laboratory blood tests, clinical measurements, capillary glucose measures, wearable sensors, air displacement plethysmography and digital questionnaires. The primary outcome is fasting plasma glucose change from BL to GW 35-37. Secondary outcomes include, for example, self-tracked capillary fasting and postprandial glucose measures, change in gestational weight gain, change in nutrition quality, change in physical activity, medication use due to GDM, birth weight and fat percentage of the child. ETHICS AND DISSEMINATION: The study has been approved by Ethics Committee of the Helsinki and Uusimaa Hospital District. The results will be presented in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: NCT04714762.