1. Lifestyle intervention to limit gestational weight gain: the Norwegian Fit for Delivery randomised controlled trial Sagedal LR, Øverby NC, Bere E, Torstveit MK, Lohne-Seiler H, Småstuen M, Hillesund ER, Henriksen T, Vistad I.

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3. Clinical Scenario A nulliparous woman visits her midwife at 13 +0 weeks. Her body mass index (BMI) is 23 kg/m 2 and she is healthy. Her dating ultrasound scan was normal. She is concerned about weight gain during pregnancy because her sister became overweight during pregnancy and struggled to lose weight after birth. She asks, “what can I do to avoid gaining too much weight during my pregnancy?”.

4. Clinical Question How to prevent obesity for both mother and child through interventions during pregnancy?

5. Background Excessive gestational weight gain is associated with increased risk of : obstetrics complications (e.g. gestational diabetes, pre- eclampsia) caesarean section macrosomia post-partum weight retention

6. Structured Question ParticipantsHealthy non-diabetic nulliparous women with BMI ≥19 kg/m 2 and singleton pregnancies InterventionAdditional dietary counselling (twice by telephone). Access to twice-weekly exercise groups at local gym, brochure, website and invitation to info-meetings and cooking classes. ComparisonStandard prenatal care OutcomesPrimary outcomes: maternal gestational weight gain (GWG), weight of the newborn, maternal fasting serum glucose level, incidence of operative delivery Study DesignRandomised controlled trial (RCT; Trial registration number: NCT01001689)

7. Background Which additional factors you may consider when you counsel this woman? Which interventions for reducing GWG have been evaluated in the past? (See Thangaratinam S, et al. in suggested reading) Which was the most commonly used study design in these previous studies? (See Thangaratinam S, et al. in suggested reading)

8. CONSORT flow Diagram

9. Methods Critical appraise this RCT using the Critical Appraisal Skill Programme (CASP; http://www.casp-uk.net/) checklist for RCThttp://www.casp-uk.net/ Base on your assessment, what are the strengths and weaknesses of this RCT? Which parameter was used in the power calculation of this RCT? How does it impact on the design of this study?

10. Baseline Characteristics Intervention (n=296) Control (n=295) MeanSDMeanSD Age (years) 27.94.228.14.5 Gestational age at inclusion (weeks) 15.42.615.62.4 n%n% BMI category, pre-pregnancy Underweight (inclusion error)20.731.0 Normal-weight20167.921773.6 Overweight6923.35418.3 Obese248.1217.1 Educational level: 12 years or less9431.89331.5 <4 years of higher education10435.18829.8 ≥4 years of higher education9632.411338.3 Participants were similar in the two groups. The majority were educated caucasian women with normal pre-pregnancy weight (See Table 1 of the paper for complete report of baseline characteristics)

11. Gestational weight gain Intervention (n=296) Control (n=295)Intervention effect MeanSDMeanSD Mean Diff.95% CI p-value Gestational weight gain (GWG), kg pre-pregnancy to term delivery 14.46.215.85.7-1.3-2.4, -0.30.009 inclusion to term delivery 12.24.313.14.9-0.9-1.7, -0.030.043 GWG rate, kg/week pre-pregnancy to last recorded weight 0.360.150.390.14-0.03 -0.06, - 0.01 0.008 inclusion to last recorded weight 0.500.210.540.20-0.03 -0.07, - 0.00 0.040 N%N%OR95% CI p-value Excessive GWG* for total GWG in term pregnancies 11141.613350.00.710.51, 1.000.056 for GWG rate at third trimester 15455.417362.50.750.53. 1.040.091 *According to Institute of Medicine guidelines

12. Obstetrics outcomes Intervention (n=296) Control (n=295) Intervention effect N%N%OR95% CIp-value Gestational Diabetes Elevated 2-hour glucose tolerance test 3211.8259.11.330.77, 2.320.330 Insulin-treated gestational diabetes 51.710.3*** Pre-eclampsiaAll cases 103.4155.20.650.29, 1.470.314 Severe preeclampsia/ HELLP/eclampsia 72.482.80.870.31, 2.410.800 Operative Delivery Elective caesarean section82.772.41.030.63, 1.681.00 Acute caesarean section3010.1299.81.040.61, 1.781.00 Forcep-assisted delivery186.1175.81.060.54, 2.111.00 Vacuum-assisted delivery299.8299.81.000.58, 1.721.00 Delivery complications Shoulder dystocia20.931.9*** Perineal laceration, Grade 3/493.59 1.000.39, 2.551.00 Postpartum haemorrhage, ≥500 ml6020.35719.31.060.71, 1.590.837 *Not calculated due to small numbers

13. Neonatal outcomes Intervention (n=296) Control (n=295) Intervention effect N%N%OR95% CIp-value Large for gestational age > 4000 g at term3311.83914.00.820.50, 1.350.451 > 4500 g at term20.751.8*** ≥ 90th percentile adjusted for sex and gestational age 72.4113.70.630.24, 1.640.351 Small for gestational age ≤ 10th percentile adjusted for sex and gestational age 3110.5279.21.160.68, 2.000.679 Adverse outcomes Admission Neonatal Intensive Care3812.83812.90.990.61, 1.611.00 Admission Neonatal Intensive Care, >24 hours 3110.43511.90.870.52, 1.440.603 Apgar 5 min <710.362.0*** Stillbirth010.3*** *Not calculated due to small numbers

14. Results How do the demographics of the study participants compare to women you encounter in your practice? Can you determine the potential differences in outcomes between participants who had normal BMI ( 25 kg/m 2 ) using the presented results?

15. Discussions How does this RCT enhance your practice, in view of the existing evidence (see suggested reading)? How would you advice the woman in the scenario?

16. Authors’ conclusions The Norwegian Fit for Delivery lifestyle intervention in pregnancy resulted in significant reduction in gestational weight gain did not reduce measured obstetrics complications did not reduce the proportion of large newborns

17. Suggested reading Thangaratinam S, et al. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. Sagedal LR, Øverby NC, Lohne-Seiler H, Bere E, Torstveit MK, Henriksen T, Vistad I. Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial. BMC Public Health. 2013 Feb 13;13:132. Gillman MW, Ludwig DS. How Early Should Obesity Prevention Start? New England Journal of Medicine. 2013;369(23):2173-5. Phelan S. Pregnancy: a "teachable moment" for weight control and obesity prevention. Am J Obstet Gynecol. 2010;202(2):135-8. Carreno CA, Clifton RG, Hauth JC, Myatt L, Roberts JM, Spong CY, et al. Excessive early gestational weight gain and risk of gestational diabetes mellitus in nulliparous women. Obstet Gynecol. 2012 Jun;119(6):1227-33. Margerison Zilko CE, Rehkopf D, Abrams B. Association of maternal gestational weight gain with short- and long-term maternal and child health outcomes. Am J Obstet Gynecol. 2010 Jun;202(6):574.e1-8 Ludwig DS, Currie J. The association between pregnancy weight gain and birthweight: a within-family comparison. Lancet. 2010 Sep 18;376(9745):984-90.

18. Authors’ Affiliations Linda R. Sagedal M.D.,¹ Nina C. Øverby Ph.D.,² Elling Bere Ph.D., ² Monica K. Torstveit Ph.D.,² Hilde Lohne-Seiler,² Milada Småstuen Ph.D.,³ Elisabet R. Hillesund Ph.D.,² Tore Henriksen M.D. Ph.D.,⁴ Ingvild Vistad M.D. Ph.D.¹ ¹ Department of Obstetrics and Gynaecology/ Department of Research, Sørlandet Hospital, Kristiansand, Norway ² Department of Public Health, Sports and Nutrition, University of Agder, Kristiansand, Norway ³ Department of Medicine, University of Oslo, Norway ⁴ Section of Obstetrics, Women and Children’s Division, Oslo University Hospital and University of Oslo, Norway LRS received a research grant from the South-Eastern Norway Regional Health Authority in order to perform the NFFD trial. The authors declare that they have no conflict of interests. Correspondence to linda.sagedal@sshf.nolinda.sagedal@sshf.no