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Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial protocol.

ABSTRACT: INTRODUCTION:Obesity represents a significant health burden, and WHO recognises the importance of preventing weight gain and subsequent development of obesity among adults who are within the healthy weight range. Women of reproductive age have demonstrated high rates of weight gain during pregnancy placing them at risk of becoming overweight or obese. We will evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women of normal body mass index (BMI). METHODS AND ANALYSIS:We will conduct a randomised controlled trial, consenting and randomising women with a live singleton pregnancy between 10+0 and 20+0 weeks and BMI 18.5-24.9?kg/m2 at first antenatal visit, from a tertiary maternity hospital. Women randomised to the Lifestyle Advice Group will receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant) and three telephone calls over pregnancy, in which they will be provided with dietary and lifestyle advice and encouraged to make change using a SMART goals approach. Women randomised to the Standard Care Group will receive routine antenatal care. The primary outcome is infant birth weight >4?kg. Secondary outcomes will include adverse infant and maternal outcomes, maternal weight change, maternal diet and physical activity changes, maternal quality of life and emotional well-being, fetal growth and costs of healthcare. We will recruit 624 women to detect a reduction from 8.72% to 3.87% (alpha 0.05 (two-tailed); power 70%) in infants with birth weight >4?kg. Analyses will be intention to treat with estimates reported as relative risks and 95% CIs. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Women's and Children's Hospital ethics committee. Findings will be disseminated widely via journal publication and conference presentation(s), and participants informed of results. TRIAL REGISTRATION NUMBER:ACTRN12614000583640.

SUBMITTER: Dodd JM

PROVIDER: S-EPMC5855335 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial protocol.

Dodd Jodie M JM Deussen Andrea R AR Louise Jennie J

BMJ open 20180220 2

<h4>Introduction</h4>Obesity represents a significant health burden, and WHO recognises the importance of preventing weight gain and subsequent development of obesity among adults who are within the healthy weight range. Women of reproductive age have demonstrated high rates of weight gain during pregnancy placing them at risk of becoming overweight or obese. We will evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women o ...[more]

PMID: 29463591

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Project description:ImportanceBoth low and high gestational weight gain have been associated with adverse maternal and infant outcomes, but optimal gestational weight gain remains uncertain and not well defined for all prepregnancy weight ranges.ObjectivesTo examine the association of ranges of gestational weight gain with risk of adverse maternal and infant outcomes and estimate optimal gestational weight gain ranges across prepregnancy body mass index categories.Design, setting, and participantsIndividual participant-level meta-analysis using data from 196 670 participants within 25 cohort studies from Europe and North America (main study sample). Optimal gestational weight gain ranges were estimated for each prepregnancy body mass index (BMI) category by selecting the range of gestational weight gain that was associated with lower risk for any adverse outcome. Individual participant-level data from 3505 participants within 4 separate hospital-based cohorts were used as a validation sample. Data were collected between 1989 and 2015. The final date of follow-up was December 2015.ExposuresGestational weight gain.Main outcomes and measuresThe main outcome termed any adverse outcome was defined as the presence of 1 or more of the following outcomes: preeclampsia, gestational hypertension, gestational diabetes, cesarean delivery, preterm birth, and small or large size for gestational age at birth.ResultsOf the 196 670 women (median age, 30.0 years [quartile 1 and 3, 27.0 and 33.0 years] and 40 937 were white) included in the main sample, 7809 (4.0%) were categorized at baseline as underweight (BMI <18.5); 133 788 (68.0%), normal weight (BMI, 18.5-24.9); 38 828 (19.7%), overweight (BMI, 25.0-29.9); 11 992 (6.1%), obesity grade 1 (BMI, 30.0-34.9); 3284 (1.7%), obesity grade 2 (BMI, 35.0-39.9); and 969 (0.5%), obesity grade 3 (BMI, ≥40.0). Overall, any adverse outcome occurred in 37.2% (n = 73 161) of women, ranging from 34.7% (2706 of 7809) among women categorized as underweight to 61.1% (592 of 969) among women categorized as obesity grade 3. Optimal gestational weight gain ranges were 14.0 kg to less than 16.0 kg for women categorized as underweight; 10.0 kg to less than 18.0 kg for normal weight; 2.0 kg to less than 16.0 kg for overweight; 2.0 kg to less than 6.0 kg for obesity grade 1; weight loss or gain of 0 kg to less than 4.0 kg for obesity grade 2; and weight gain of 0 kg to less than 6.0 kg for obesity grade 3. These gestational weight gain ranges were associated with low to moderate discrimination between those with and those without adverse outcomes (range for area under the receiver operating characteristic curve, 0.55-0.76). Results for discriminative performance in the validation sample were similar to the corresponding results in the main study sample (range for area under the receiver operating characteristic curve, 0.51-0.79).Conclusions and relevanceIn this meta-analysis of pooled individual participant data from 25 cohort studies, the risk for adverse maternal and infant outcomes varied by gestational weight gain and across the range of prepregnancy weights. The estimates of optimal gestational weight gain may inform prenatal counseling; however, the optimal gestational weight gain ranges had limited predictive value for the outcomes assessed.

Project description:ImportanceThe associations of gestational weight gain (GWG) with infant morbidity and mortality are unclear, and the existing recommendations for GWG have not been stratified by the severity of obesity.ObjectivesTo identify optimal GWG ranges associated with reduced risks of infant morbidity and mortality across maternal body mass index (BMI) categories.Design, setting, and participantsThis retrospective cohort study used US nationwide, linked birth and infant death data between 2011 and 2015 to assess the associations of GWG in 2.0-kg groups with infant morbidity and mortality and identified optimal GWG ranges associated with reduced risks of both outcomes, using multivariable logistic regression models. Statistical analysis was performed from February 11 to October 14, 2021.ExposureGestational weight gain equivalent to 40 weeks.Main outcomes and measuresThe 2 main outcomes were (1) significant morbidity of the newborn infant, defined as any presence of assisted ventilation, admission to the neonatal intensive care unit, surfactant therapy, antibiotic therapy, or seizures; and (2) infant mortality younger than 1 year of age (<1 hour, 1-23 hours, 1-6 days, 7-27 days, or 28-365 days after birth).ResultsIn this study of 15 759 945 mother-infant dyads, the mean (SD) age of the women was 28.1 (5.9) years. Women gained a mean (SD) of 14.1 (7.3) kg during pregnancy, and the mean (SD) GWG decreased with BMI categories (underweight, 15.7 [6.4] kg; normal weight, 15.4 [6.2] kg; overweight, 14.2 [7.4] kg; obesity class 1, 12.2 [8.0] kg; obesity class 2, 10.3 [8.4] kg; obesity class 3, 8.2 [9.2] kg; P < .001). A total of 8.8% of the newborns experienced significant morbidity, with the lowest prevalence among infants delivered by women in the normal weight BMI class (8.0%) and the highest among infants delivered by women with class 3 obesity (12.4%); 0.34% of infants died within 1 year of birth, with the lowest prevalence among infants delivered by women in the normal weight BMI class (0.28%) and the highest among infants delivered by women with class 3 obesity (0.58%). Optimal GWG ranges were 12.0 to less than 24.0 kg for underweight and normal weight women, 10.0 to less than 20.0 kg for overweight women, 8.0 to less than 16.0 kg for women with class 1 obesity, 6.0 to less than 16.0 kg for class 2 obesity, and 6.0 to less than 10.0 kg for class 3 obesity. The lower bounds of the optimal GWG ranges appeared to be higher than the existing recommendations for overweight women (10.0 vs 7.0 kg) and for those with class 1 (8.0 vs 5.0 kg), class 2 (6.0 vs 5.0 kg), and class 3 (6.0 vs 5.0 kg) obesity.Conclusions and relevanceThis study analyzed the associations of GWG with infant morbidity and mortality across BMI categories and found that inadequate GWG was associated with increased risks of adverse infant outcomes even for women with obesity. The results suggested that weight maintenance or weight loss should not be used as routine guidelines.

Dataset Information

Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial protocol.

Publications

Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial protocol.

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