Dataset Information

Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial.

ABSTRACT:

Background

Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing.

Method/design

A randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 k/gm2) or obese (BMI >30?kgm/2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief ( less than 5 minute) phone contact will alternate with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation.

Discussion

Evidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.

Trial registration

This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000125729.

SUBMITTER: Nagle C

PROVIDER: S-EPMC3669050 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Publications

Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial.

Nagle Cate C Skouteris Helen H Morris Heather H Nankervis Alison A Rasmussen Bodil B Mayall Peter P Kennedy Richard L RL

BMC pregnancy and childbirth 20130313

<h4>Background</h4>Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on impr ...[more]

PMID: 23497264

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Project description:BackgroundAlthough in 2013 the American College of Obstetricians and Gynecologists recommended early screening for gestational diabetes in obese women, no studies demonstrate an improvement in perinatal outcomes with this strategy.ObjectiveWe sought to determine whether early screening for gestational diabetes improves perinatal outcomes in obese women.Materials and methodsRandomized controlled trial comparing early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (body mass index ≥30 kg/m2) at 2 tertiary care centers in the United States. Screening was performed using a 50-g, 1-hour glucose challenge test followed by a 100-g, 3-hour glucose tolerance test if the initial screen was ≥135 mg/dL. Gestational diabetes was diagnosed using Carpenter-Coustan criteria. Women not diagnosed at 14 to 20 weeks were rescreened at 24 to 28 weeks. Exclusion criteria were pre-existing diabetes, major medical illness, bariatric surgery, and prior cesarean delivery. The primary outcome was a composite of macrosomia (>4000 g), primary cesarean delivery, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth).ResultsA total of 962 women were randomized, and outcomes were available for 922. Of these 922 women, 459 (49.8%) were assigned to early screen and 463 (50.2%) to routine screen. Baseline characteristics were balanced between groups. In the early screening group, 69 (15.0%; 95% confidence interval, 11.9-18.6%) were diagnosed with gestational diabetes: 29 (6.3%; 95% confidence interval, 4.3-8.9%) at <20 weeks and 40 (8.7%; 95% confidence interval, 6.3-11.7%) at >24 weeks. Of those randomized to routine screening, 56 (12.1%; 95% confidence interval, 9.3-15.4%) had gestational diabetes. Early screening did not reduce the incidence of the primary outcome (56.9% in the early screen versus 50.8% in the routine screen, P = .07; relative risk, 1.12; 95% confidence interval, 0.99-1.26).ConclusionEarly screening for gestational diabetes in obese women did not reduce the composite perinatal outcome.

Project description:BackgroundThe increased prevalence of obesity in pregnant women in Australia and other developed countries is a significant public health concern. Obese women are at increased risk of serious perinatal complications and guidelines recommend weight gain restriction and additional care. There is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing adverse perinatal outcomes and new strategies need to be evaluated. The primary aim of this project is to evaluate the effect of continuity of midwifery care on restricting gestational weight gain in obese women to the recommended range. The secondary aims of the study are to assess the impact of continuity of midwifery care on: women's experience of pregnancy care; women's satisfaction with care and a range of psychological factors.Methods/designA two arm randomised controlled trial (RCT) will be conducted with primigravid women recruited from maternity services in Victoria, Australia. Participants will be primigravid women, with a BMI ≥ 30 who are less than 17 weeks gestation. Women allocated to the intervention arm will be cared for in a midwifery continuity of care model and receive an informational leaflet on managing weight gain in pregnancy. Women allocated to the control group will receive routine care in addition to the same informational leaflet. Weight gain during pregnancy, standards of care, medical and obstetric information will be extracted from medical records. Data collected at recruitment (self administered survey) and at 36 weeks by postal survey will include socio-demographic information and the use of validated scales to measure secondary outcomes.DiscussionContinuity of midwifery care models are well aligned with current Victorian, Australian and many international government policies on maternity care. Increasingly, midwifery continuity models of care are being introduced in low risk maternity care, and information on their application in high risk populations is required. There is an identified need to trial alternative antenatal interventions to reduce perinatal risk factors for women who are obese and the findings from this project may have application in other maternity services. In addition this study will inform a larger trial that will focus on birth and postnatal outcomes.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610001078044.

Project description:ObjectiveTo describe the mediating effect of maternal gestational diabetes on fetal biometry and adiposity measures among overweight or obese pregnant women.DesignSecondary analysis of the LIMIT randomised trial.SettingPublic hospitals, metropolitan Adelaide, South Australia.PopulationPregnant women with body mass index (BMI) ?25 kg/m2 and singleton gestation.MethodsFetal ultrasound measures at 36 weeks of gestation and baseline BMI from women randomised to the LIMIT trial Standard Care group (n = 912 women) were used to conduct causal mediation analyses using regression-based methods.Main outcomes measuresUltrasound measures of fetal biometry and adiposity at 36 weeks of gestation.ResultsIncreased maternal BMI was associated with increased measures of fetal head circumference [direct (unmediated) effect 0.18 (95% CI: 0.05-0.31), P = 0.005; total effect 0.17 (95% CI: 0.02-0.31), P = 0.018], abdominal circumference [direct effect 0.26 (95% CI: 0.11-0.41), P = 0.001; total effect 0.26 (95% CI: 0.11-0.42), P = 0.001] and estimated fetal weight [direct effect 0.22 (95% CI: 0.08-0.35), P = 0.002; total effect 0.22 (95% CI: 0.08-0.35), P = 0.002], with no evidence of mediation by treated gestational diabetes. There was no apparent association between maternal BMI and fetal adiposity measures, or mediation by treated gestational diabetes.ConclusionsWe show an important association between increased maternal BMI and fetal growth, not mediated by treated gestational diabetes. There was no association between increased maternal BMI and fetal adiposity measures, or mediation by treated gestational diabetes. Whether these findings represent 'saturation' in the effect of maternal BMI on fetal growth or the effect of treatment of GDM is unclear.FundingThis project was funded by a 4-year project grant from the National Health and Medical Research Council (NHMRC), Australia (ID 519240); The Channel 7 Children's Research Foundation, South Australia; and the US National Institutes of Health (R01 HL094235-01).Tweetable abstractIncreased fetal growth associated with maternal obesity is not mediated by gestational diabetes.

Project description:BACKGROUND:Gestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year. METHODS AND FINDINGS:In this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: -0.23 kg body weight in intervention group (95% CI -0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference -0.95 kg, 95% CI -1.87, -0.04; group by treatment interaction p = 0.04); -2.24 cm waist measurement in intervention group (95% CI -3.01, -1.42) compared with -1.74 cm in usual care group (95% CI -2.52, -0.96) (change difference -0.50 cm, 95% CI -1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference -0.05 mmol/l, 95% CI -0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline. CONCLUSIONS:Although a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12610000338066.

Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.

Project description:BackgroundExcessive gestational weight gain is associated with adverse infant, childhood and maternal outcomes and research to develop interventions to address this issue is ongoing. The views of women on gestational weight gain and the resources they would consider helpful in addressing this are however largely unknown. This survey aimed to determine the views of newly pregnant women, living in areas of social disadvantage, on 1) their current body weight and potential gestational weight gain and 2) the resources or interventions they would consider helpful in preventing excessive gestational weight gain.MethodsA convenience sample of overweight and obese pregnant women living in Fife, UK, were invited to complete a short anonymised questionnaire at their 12 week booking visit.Results428 women, BMI>25 kg/m(2), completed the questionnaire. Fifty-four per cent of respondents were obese (231) and 62% were living in areas of mild to moderate deprivation. Over three-quarters of participants felt dissatisfied with their current weight (81%). The majority of women (60%) expressed some concern about potential weight gain. Thirty-nine percent were unconcerned about weight gain during their pregnancy, including 34 women (19%) who reported having retained weight gained in earlier pregnancies. Amongst those concerned about weight gain advice on physical activity (41%) and access to sports/leisure facilities were favoured resources (36%). Fewer women (12%) felt that group sessions on healthy eating or attending a clinic for individualised advice (14%) would be helpful. "Getting time off work" was the most frequently cited barrier (48%) to uptake of resources other than leaflets.ConclusionsThese data suggest a lack of awareness amongst overweight and obese women regarding excessive gestational weight gain. Monitoring of gestational weight gain, and approaches for its management, should be formally integrated into routine antenatal care. Barriers to the uptake of resources to address weight gain are numerous and must be considered in the design of future interventions and services.

Project description:BackgroundGestational diabetes mellitus (GDM) is one of the most common complications of pregnancy and its prevalence worldwide is increasing along with enhancing type two of diabetes. Contrary results have been found in some review articles that examine the effect of exercise activities on preventing GDM, regardless of obesity. Therefore, the aim of this study was to systematically review the articles on the effect of exercise activities on the prevention of GDM in obese and overweight pregnant women.Main textLiterature was retrieved by formally searching PubMed, Embase, Cochrane library, Web of Science, Scopus, Proquest and by hand searching of reference lists of related articles. Finally, a total of eight literatures included, and Review manager 5.3 and STATA 14.0 statistical software were utilized for processing. In order to investigate the effect of sports activities on the incidence of GDM, the risk ratio (RR), and for quantitative indices, the standardized mean difference (SMD) with 95% confidence interval (CI) for each study was calculated. Out of 5107 papers identified, eight papers with 1441 participants included in meta-analysis (intervention group 727, control group 714). In the intervention group, 143 (19.66%, 95% CI 76.83 to 22.74) and in the control group, 196 (27.45%, 95% CI 20.24 to 30.88%), pregnant women had diabetes. The RR of gestational diabetes was 0.76 (95% CI 0.56 to 1.03, I2?=?50%, P?=?0.05). In studies that the time for the intervention was three times a week or less, effect of intervention was significant in reducing the incidence of diabetes (RR: 0.59, 95% CI 0.46 to 0.76, I2?=?0%, P?=?0.47). However, in studies with repeat of intervention was more than three times a week, the effect of intervention between two intervention and control groups was not different (RR: 1.03, 95% CI 0.78 to 1.35, I2?=?0%, P?=?0.46).ConclusionsThe exercise activities, alone, in obese or overweight pregnant women did not have a significant effect on the overall incidence of GDM, but considering the effect measure, the incidence of GDM was 24% lower in the intervention group than control group. This difference is considerable in the two groups. As the systematic review literatures both represent the information gap on the research subject and pave the way for further studies so it seems that there is a need for more randomized controlled trials so that we can make a complete conclusion on the type, intensity and duration of exercise in preventing GDM.

Project description:BackgroundOur objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.Method and findingsWe conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ? 25 kg/m(2), glucose intolerance or newborn's macrosomia (? 4,500 g) in any earlier pregnancy, family history of diabetes, age ? 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p ?=? 0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.ConclusionsThe intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.Trial registrationCurrent Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary.

Dataset Information

Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial.

Background

Method/design

Discussion

Trial registration

Publications

Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial.

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