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Effect of metformin in addition to an antenatal diet and lifestyle intervention on fetal growth and adiposity: the GRoW randomised trial.

ABSTRACT: BACKGROUND:The infants born to women who are overweight or obese in pregnancy are at an increased risk of being born macrosomic or large for gestational age. Antenatal dietary and lifestyle interventions have been shown to be ineffective at reducing this risk. Our aim was to examine the effects of metformin in addition to a diet and lifestyle intervention on fetal growth and adiposity among women with a BMI above the healthy range. METHODS:Women who had a body mass index ?25?kg/m2 in early pregnancy, and a singleton gestation, were enrolled in the GRoW trial from three public maternity hospitals in metropolitan Adelaide. Women were invited to have a research ultrasounds at 28 and 36?weeks' gestation at which ultrasound measures of fetal biometry and adiposity were obtained. Fetal biometry z-scores and trajectories were calculated. Measurements and calculations were compared between treatment groups. This secondary analysis was pre-specified. RESULTS:Ultrasound data from 511 women were included in this analysis. The difference in femur length at 36?weeks' gestation was (0.07?cm, 95% CI 0.01-0.14?cm, p?=?0.019) and this was was statistically significant, however the magnitude of effect was small. Differences between treatment groups for all other fetal biometry measures, z-scores, estimated fetal weight, and adiposity measures at 28 and 36?weeks' gestation were similar. CONCLUSIONS:The addition of metformin to dietary and lifestyle advice in pregnancy for overweight and obese women has no clinically relevant effect on ultrasound measures of fetal biometry or adiposity. TRIAL REGISTRATION:Australian and New Zealand Clinical Trials Registry ( ACTRN12612001277831 ).

SUBMITTER: Poprzeczny AJ

PROVIDER: S-EPMC7488668 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Effect of metformin in addition to an antenatal diet and lifestyle intervention on fetal growth and adiposity: the GRoW randomised trial.

Poprzeczny Amanda J AJ Louise Jennie J Deussen Andrea R AR Dodd Jodie M JM

BMC endocrine disorders 20200914 1

<h4>Background</h4>The infants born to women who are overweight or obese in pregnancy are at an increased risk of being born macrosomic or large for gestational age. Antenatal dietary and lifestyle interventions have been shown to be ineffective at reducing this risk. Our aim was to examine the effects of metformin in addition to a diet and lifestyle intervention on fetal growth and adiposity among women with a BMI above the healthy range.<h4>Methods</h4>Women who had a body mass index ≥25 kg/m< ...[more]

PMID: 32928167

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Project description:ObjectiveTo test the effect of a multidimensional lifestyle intervention on aerobic fitness and adiposity in predominantly migrant preschool children.DesignCluster randomised controlled single blinded trial (Ballabeina study) over one school year; randomisation was performed after stratification for linguistic region.Setting40 preschool classes in areas with a high migrant population in the German and French speaking regions of Switzerland.Participants652 of the 727 preschool children had informed consent and were present for baseline measures (mean age 5.1 years (SD 0.7), 72% migrants of multicultural origins). No children withdrew, but 26 moved away.InterventionThe multidimensional culturally tailored lifestyle intervention included a physical activity programme, lessons on nutrition, media use (use of television and computers), and sleep and adaptation of the built environment of the preschool class. It lasted from August 2008 to June 2009.Main outcome measuresPrimary outcomes were aerobic fitness (20 m shuttle run test) and body mass index (BMI). Secondary outcomes included motor agility, balance, percentage body fat, waist circumference, physical activity, eating habits, media use, sleep, psychological health, and cognitive abilities.ResultsCompared with controls, children in the intervention group had an increase in aerobic fitness at the end of the intervention (adjusted mean difference: 0.32 stages (95% confidence interval 0.07 to 0.57; P=0.01) but no difference in BMI (-0.07 kg/m(2), -0.19 to 0.06; P=0.31). Relative to controls, children in the intervention group had beneficial effects in motor agility (-0.54 s, -0.90 to -0.17; P=0.004), percentage body fat (-1.1%, -2.0 to -0.2; P=0.02), and waist circumference (-1.0 cm, -1.6 to -0.4; P=0.001). There were also significant benefits in the intervention group in reported physical activity, media use, and eating habits, but not in the remaining secondary outcomes.ConclusionsA multidimensional intervention increased aerobic fitness and reduced body fat but not BMI in predominantly migrant preschool children. Trial registration Clinical Trials NCT00674544.

Project description:IntroductionAlthough the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes.Study designRCT.Setting/participantsNinety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013-2015 and analyzed in 2016.InterventionThe 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care.Main outcome measuresWeight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months.ResultsILI participants demonstrated significantly greater mean weight loss (-4.0 kg, 5.0%) than metformin (-0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063).ConclusionsIn the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

Project description:IntroductionDespite evidence that iron and folic acid (IFA) supplements can improve anaemia in pregnant women, uptake in Nepal is suboptimal. We hypothesised that providing virtual counselling twice in mid-pregnancy, would increase compliance to IFA tablets during the COVID-19 pandemic compared with antenatal care (ANC alone.Methods and analysisThis non-blinded individually randomised controlled trial in the plains of Nepal has two study arms: (1) control: routine ANC; and (2) 'Virtual' antenatal counselling plus routine ANC. Pregnant women are eligible to enrol if they are married, aged 13-49 years, able to respond to questions, 12-28 weeks' gestation, and plan to reside in Nepal for the next 5 weeks. The intervention comprises two virtual counselling sessions facilitated by auxiliary nurse midwives at least 2 weeks apart in mid-pregnancy. Virtual counselling uses a dialogical problem-solving approach with pregnant women and their families. We randomised 150 pregnant women to each arm, stratifying by primigravida/multigravida and IFA consumption at baseline, providing 80% power to detect a 15% absolute difference in primary outcome assuming 67% prevalence in control arm and 10% loss-to-follow-up. Outcomes are measured 49-70 days after enrolment, or up to delivery otherwise.Primary outcomeconsumption of IFA on at least 80% of the previous 14 days.Secondary outcomesdietary diversity, consumption of intervention-promoted foods, practicing ways to enhance bioavailability and knowledge of iron-rich foods. Our mixed-methods process evaluation explores acceptability, fidelity, feasibility, coverage (equity and reach), sustainability and pathways to impact. We estimate costs and cost-effectiveness of the intervention from a provider perspective. Primary analysis is by intention-to-treat, using logistic regression.Ethics and disseminationWe obtained ethical approval from Nepal Health Research Council (570/2021) and UCL ethics committee (14301/001). We will disseminate findings in peer-reviewed journal articles and by engaging policymakers in Nepal.Trial registration numberISRCTN17842200.

Dataset Information

Effect of metformin in addition to an antenatal diet and lifestyle intervention on fetal growth and adiposity: the GRoW randomised trial.

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Effect of metformin in addition to an antenatal diet and lifestyle intervention on fetal growth and adiposity: the GRoW randomised trial.

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