A Randomised Trial to Optimise Gestational Weight Gain and Improve Maternal and Infant Health Outcomes through Antenatal Dietary, Lifestyle and Exercise Advice: The OPTIMISE Randomised Trial.
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SUBMITTER: Dodd JM
PROVIDER: S-EPMC6949931 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: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.
| S-EPMC5855335 | biostudies-literature
Project description:ObjectiveTo report the influence of maternal overweight and obesity on fetal growth and adiposity and effects of an antenatal dietary and lifestyle intervention among these women on measures of fetal growth and adiposity as secondary outcomes of the LIMIT Trial.DesignRandomised controlled trial.SettingPublic maternity hospitals in metropolitan Adelaide, South Australia.PopulationPregnant women with a body mass index ≥ 25 kg/m(2), and singleton gestation between 10(+0) and 20(+0) weeks.MethodsWomen were randomised to Lifestyle Advice or continued Standard Care and offered two research ultrasound scans at 28 and 36 weeks of gestation.Main outcome measuresUltrasound measures of fetal growth and adiposity.ResultsFor each fetal body composition parameter, mean Z-scores were substantially higher when compared with population standards. Fetuses of women receiving Lifestyle Advice demonstrated significantly greater mean mid-thigh fat mass, when compared with fetuses of women receiving Standard Care (adjusted difference in means 0.17; 95% CI 0.02-0.32; P = 0.0245). While subscapular fat mass increased between 28 and 36 weeks of gestation in fetuses in both treatment groups, the rate of adipose tissue deposition slowed among fetuses of women receiving Lifestyle Advice, when compared with fetuses of women receiving Standard Care (P = 0.0160). No other significant differences were observed.ConclusionsThese findings provide the first evidence of changes to fetal growth following an antenatal dietary and lifestyle intervention among women who are overweight or obese.
| S-EPMC4742332 | biostudies-literature
Project description:ObjectiveTo evaluate the effect of providing antenatal dietary and lifestyle advice on neonatal anthropometry, and to determine the inter-observer variability in obtaining anthropometric measurements.DesignRandomised controlled trial.SettingPublic maternity hospitals across metropolitan Adelaide, South Australia.PopulationPregnant women with a singleton gestation between 10(+0) and 20(+0) weeks, and body mass index (BMI) ≥25 kg/m(2).MethodsWomen were randomised to either Lifestyle Advice (comprehensive dietary and lifestyle intervention over the course of pregnancy including dietary, exercise and behavioural strategies, delivered by a research dietician and research assistants) or continued Standard Care. Analyses were conducted using intention-to-treat principles.Main outcome measuresSecondary outcome measures for the trial included assessment of infant body composition using body circumference and skinfold thickness measurements (SFTM), percentage body fat, and bio-impedance analysis of fat-free mass.ResultsAnthropometric measurements were obtained from 970 neonates (488 Lifestyle Advice Group, and 482 Standard Care Group). In 394 of these neonates (215 Lifestyle Advice Group, and 179 Standard Care Group) bio-impedance analysis was also obtained. There were no statistically significant differences identified between those neonates born to women receiving Lifestyle Advice and those receiving Standard Care, in terms of body circumference measures, SFTM, percentage body fat, fat mass, or fat-free mass. The intra-class correlation coefficient for SFTM was moderate to excellent (0.55-0.88).ConclusionsAmong neonates born to women who are overweight or obese, anthropometric measures of body composition were not modified by an antenatal dietary and lifestyle intervention.
| S-EPMC4859433 | biostudies-literature
Project description:Many pregnant women gain excess weight during pregnancy which increases the health risks to the mother and her baby. Interventions to prevent excess weight gain need to be given to the whole population to prevent excess weight gain. The aim of this study was to assess the effectiveness of a simple and brief intervention embedded withinroutine antenatal care to prevent excessive gestation weight gain.Six hundred and ten pregnant women (between 10-14 weeks gestation), aged ≥18 years with a body mass index (BMI) ≥18.5 kg/m2, planned to receive community midwife led care or shared care at the time of recruitment are eligible to take part in the study. Women will be recruited from four maternity centres in England. Community midwives complete a short training module before delivering the intervention. In the intervention, midwives weigh women, set maximum weight limits for weight gain at each antenatal appointment and ask women to monitor their weight at home. Themaximum weight limit is adjusted by the midwife at each antenatal appointment if women have exceeded their maximum weight gain limit set at their previous appointment. The intervention will be compared with usual antenatal care. The primary outcome is the proportion of women per group who exceed the Institute of Medicine guidelines for gestational weight gain at 38 weeks of pregnancy according to their early pregnancy BMI category.The proposed trial will test a brief intervention comprising regular weighing, target setting and monitoring ofweight during pregnancy that can be delivered at scale as part of routine antenatal care. Using the professional expertise of community midwives, but without specialist training in weight management, the intervention will incur minimal additionalhealthcare costs, and if effective at reducing excess weight gain, is likely to be very cost effective.Current controlled trials ISRCTN67427351. Date assigned 29/10/2014.
| S-EPMC4743115 | biostudies-other
Project description:BACKGROUND:Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity. METHODS:The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 recruited from gynaecological and midwifery practices prior to the end of the 12th week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided. RESULTS:The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66-1.38, p = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively (p = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g, p = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm, p = 0.001). CONCLUSION:In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed. TRIAL REGISTRATION:NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.
| S-EPMC6330753 | biostudies-literature
Project description:BackgroundThe Institute of Medicine (IOM) revised gestational weight gain recommendations in 2009. We examined associations between healthcare provider advice about gestational weight gain and inadequate or excessive weight gain, stratified by prepregnancy body mass index category.Materials and methodsWe analyzed cross-sectional data from women delivering full-term (37-42 weeks of gestation), singleton infants from four states that participated in the 2010-2011 Pregnancy Risk Assessment Monitoring System (unweighted n = 7125). Women reported the weight gain range (start and end values) advised by their healthcare provider; advice was categorized as follows: starting below recommendations, starting and ending within recommendations (IOM consistent), ending above recommendations, not remembered, or not received. We examined associations between healthcare provider advice and inadequate or excessive, compared with appropriate, gestational weight gain using adjusted prevalence ratios (aPR) and 95% confidence intervals (CIs).ResultsOverall, 26.3% of women reported receiving IOM-consistent healthcare provider advice; 26.0% received no advice. Compared with IOM-consistent advice, advice below recommendations was associated with higher likelihood of inadequate weight gain among underweight (aPR 2.22, CI 1.29-3.82) and normal weight women (aPR 1.57, CI 1.23-2.02); advice above recommendations was associated with higher likelihood of excessive weight gain among all but underweight women (aPR range 1.36, CI 1.08-1.72 to aPR 1.42, CI 1.19-1.71). Not remembering or not receiving advice was associated with both inadequate and excessive weight gain.ConclusionsFew women reported receiving IOM-consistent advice; not receiving IOM-consistent advice put women at-risk for weight gain outside recommendations. Strategies that raise awareness of IOM recommendations and address barriers to providing advice are needed.
| S-EPMC5962332 | biostudies-literature
Project description:ObjectivesA life-course perspective emphasizes healthy behaviors before, during, and after pregnancy to support a multi-generational risk reduction in obesity for mothers and infants. Optimal timing, content, and dose of such interventions is not well defined.MethodsWe conducted a nested cohort within a randomized trial to evaluate whether a healthy lifestyle intervention around pregnancy led to a "spill-over effect," including a healthier rate (kg/week) of maternal gestational weight gain, and infant growth during the first year. Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019. The intervention focused on healthy maternal diet and physical activity but not pregnancy weight or infant feeding. Outcome data were abstracted from electronic medical records.ResultsOf the 165 women who became pregnant, 114 enrolled in the nested cohort. The average pre-pregnancy BMI was 29.6 (SD 5.1) kg/m2. Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).Conclusions for practiceA behavioral intervention that focused on overall maternal health delivered in the time around pregnancy did not result in a "spill-over effect" on healthy gestational weight gain or healthy infant growth during the first year of life.Trial registrationThis study is registered at www.clinicaltrials.gov NCT01316653.
| S-EPMC7572871 | biostudies-literature
Project description:BackgroundThe HIV Infant Tracking System (HITSystem) is a web-based intervention linking providers of early infant diagnosis, laboratory technicians, and mothers and infants to improve outcomes for HIV-exposed infants. We aimed to evaluate the efficacy of the HITSystem on key outcomes of early infant diagnosis.MethodsWe did a cluster-randomised trial at six hospitals in Kenya, which were matched on geographic region, resource level, and volume of patients (high, medium, and low). We randomly allocated hospitals within a matched pair to either the HITSystem (intervention; n=3) or standard of care (control; n=3). A random number generator was used to assign clusters. Investigators were unaware of the randomisation process. Eligible participants were mothers aged 18 years or older with an infant younger than 24 weeks presenting for their first early infant diagnosis appointment. The primary outcome was complete early infant diagnosis retention, which was defined as receipt of all indicated age-specific interventions until 18 months post partum (for HIV-negative infants) or antiretroviral therapy initiation (for HIV-positive infants). Analysis was per protocol in all randomised pairs judged eligible, excluding infant deaths and those who moved or were transferred to another health facility. Modified intention-to-treat sensitivity analyses judged all infant deaths and transfers as incomplete early infant diagnosis retention. Separate multivariable logistic regression analyses were done with intervention group, hospital volume, and significant covariates as fixed effects. This trial is registered with ClinicalTrials.gov, number NCT02072603; the trial has been completed.FindingsBetween Feb 16, 2014, and Dec 31, 2015, 895 mother-infant pairs were enrolled. Of these, 87 were judged ineligible for analysis, 26 infants died, and 92 pairs moved or were transferred to another health facility. Thus, data from 690 mother-infant pairs were analysed, of whom 392 were allocated to the HITSystem and 298 to standard of care. Mother-infant pairs were followed up to Sept 30, 2017. Infants diagnosed as HIV-positive were followed up for a median of 2·1 months (IQR 1·6-4·8) and HIV-negative infants were followed up for a median of 17·0 months (IQR 16·6-17·6). Infants enrolled in the HITSystem were significantly more likely to receive complete early infant diagnosis services compared with those assigned standard of care (334 of 392 [85%] vs 180 of 298 [60%]; adjusted odds ratio [OR] 3·7, 95% CI 2·5-5·5; p<0·0001). No intervention effect was recorded at high-volume hospitals, but strong effects were seen at medium-volume and low-volume hospitals. Modified intention-to-treat analyses for complete early infant diagnosis were also significant (334 of 474 [70%] vs 180 of 334 [54%]; adjusted OR 2·0, 95% CI 1·4-2·7; p<0·0001). No adverse events related to study participation were reported.InterpretationThe HITSystem intervention is effective and feasible to implement in low-resource settings. The HITSystem algorithms have been modified to include HIV testing at birth, and an adapted HITSystem 2.0 version is supporting HIV-positive pregnant women to prevent perinatal transmission and optimise maternal and infant outcomes.FundingNational Institute of Child Health and Human Development.
| S-EPMC6289743 | biostudies-literature
Project description:ObjectivesTo assess the effectiveness of a brief behavioural intervention based on routine antenatal weighing to prevent excessive gestational weight gain (defined by US Institute of Medicine).DesignRandomised controlled trial.SettingAntenatal clinic in England.ParticipantsWomen between 10+0 and 14+6 weeks gestation, not requiring specialist obstetric care.InterventionsParticipants were randomised to usual antenatal care or usual care (UC) plus the intervention. The intervention involved community midwives weighing women at antenatal appointments, setting maximum weight gain limits between appointments and providing brief feedback. Women were encouraged to monitor and record their own weight weekly to assess their progress against the maximum limits set by their midwife. The comparator was usual maternity care.Primary and secondary outcome measuresExcessive gestational weight gain, depression, anxiety and physical activity.ResultsSix hundred and fifty-six women from four maternity centres were recruited: 329 women were randomised to the intervention group and 327 to UC. We found no evidence that the intervention decreased excessive gestational weight gain. At 38 weeks gestation, the proportions gaining excessive gestational weight were 27.6% (81/305) versus 28.9% (90/311) (adjusted OR 0.84, 95% CI: 0.53 to 1.33) in the intervention and UC group, respectively. There were no significant difference between the groups in anxiety or depression scores (anxiety: adjusted mean -0.58, 95% CI:-1.25 to -0.8; depression: adjusted mean -0.60, 95% CI:-1.24 to -0.05). There were no significant differences in physical activity scores between the groups.ConclusionsA behavioural intervention delivered by community midwives involving routine weighing throughout pregnancy, setting maximum weight gain targets and encouraging women to weigh themselves each week to check progress did not prevent excessive gestational weight gain. There was no evidence of psychological harm.Trial registration numberISRCTN67427351.
| S-EPMC6756421 | biostudies-literature
Project description:BackgroundInappropriate gestational weight gain (GWG) has been associated with adverse perinatal events. High rates of GWG have been reported among Hispanic women. Observational studies indicate that dietary and physical activity interventions during the prenatal period may improve maternal and infant health, but very few randomized trials have been conducted among high-risk overweight/obese Hispanic women. Accordingly, we conducted a lifestyle intervention among high-risk pregnant women and evaluated its impact on achieving appropriate GWG and on improving birthweight.MethodsEligible overweight/obese women presenting at the University Hospital in Puerto Rico with a singleton pregnancy before 16 gestational weeks were recruited and randomized to lifestyle intervention (n=15) or control group (n=16). The lifestyle intervention focused on improving physical activity and diet quality and optimizing caloric intake. We evaluated the impact of the lifestyle intervention on achieving appropriate GWG and on infant birthweight. Poisson and linear regression analyses were performed.ResultsThe primary intent to treat analysis showed no significant effect on achievement of appropriate GWG/week through 36 weeks in the intervention group (4/15 women) when compared with the control group (3/16 women) (adjusted incidence rate ratio =1.14; 95% CI: 0.20, 6.67). Although not statistically significant, women in the intervention group (6/15) were 1.7 times more likely to achieve appropriate weekly GWG until delivery when compared with controls (4/16 women) (adjusted incidence rate ratio = 1.67; 95% CI: 0.40, 6.94). We observed lower adjusted birthweight-for-length z-scores in the intervention compared with the control group among male newborns with z-score difference -1.74 (-3.04, -0.43), but not among females -0.83 (-3.85, 2.19). These analyses were adjusted for age and baseline body mass index.ConclusionAlthough larger studies are required to determine whether women with obesity may benefit from prenatal lifestyle interventions targeting GWG, our results are suggestive of the intervention improving adherence to established Institute of Medicine guidelines.
| S-EPMC6385743 | biostudies-literature