Self-weighing and simple dietary advice for overweight and obese pregnant women to reduce obstetric complications without impact on quality of life: a randomised controlled trial The Facts, Figures and Feelings about weight in pregnancy study (the FFF study) McCarthy E, Walker SP, Ugoni A, Lappas M, Leong O, Shub A

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Clinical Scenario A nulliparous woman visits her obstetrician at weeks. Her body mass index (BMI) is 35 kg/m 2, but she has no other medical history. Her dating ultrasound scan was normal. Her obstetrician explained the risks of obesity on her pregnancy. She asks, “what can I do to minimise these risks?”.

Clinical Question Could a simple, pragmatic intervention improve outcomes for overweight and obese pregnant women without causing distress?

Background More than 50% of pregnant women in Australia are overweight or obese Being overweight or obese at conception and excess weight gain during pregnancy can lead to poor obstetric outcomes for both mothers and babies

Description of Research ParticipantsOverweight or obese pregnant women at <20 weeks with a singleton pregnancy, without pre-existing diabetes InterventionSimple dietary advice, written personalised weight gain targets, encouragement of regular self-weighing and discussions of weight gain with the obstetric care provider ComparisonWritten personalised weight gain targets only OutcomesComposite primary outcome including any of: gestational diabetes; pregnancy-induced hypertension and pre-eclampsia; mode of birth other than spontaneous vertex; post-partum haemorrhage; 3rd or 4th degree perineal tear; admission to adult intensive care/ high-dependence units, maternal death DesignRandomised controlled trial (RCT; Trial registration number: ACTRN )

Background What are the risks of obesity in pregnancy for mothers and babies? Do you routinely discuss weight management with pregnant women who are overweight or obese? How would you manage the woman in the scenario, compared to women with normal weight?

Lost to follow up n=8 1 early pregnancy loss 7 birth at another maternity hospital Lost to follow up n=3 2 early pregnancy loss 1 birth at another maternity hospital Assessed for primary outcome n=184 Assessed for primary outcome n=187 Missing 28 week blood tests n=40 Missing 36 week QOL responses n=31 Missing 36 week weight n=31 Missing 28 week blood test n=63 Missing 36 week QOL responses n=36 Missing 36 week weight n= allocated to intervention 192 allocated to standard care 382 women randomised 1867 women with BMI >25 delivered singleton babies between 01 July 2010 and 9 July 2012 Analysis Follow up Enrollment Allocation

Women in both groups were given personalised weight targets, but women in the intervention group carried hand held weight records (example shown below) Routine antenatal care in Australia does not include regular weighing

Women in the intervention group Had a one-to-one interview with a midwife about diet and weight gain A simple advice card were also given Stickers were put in the women’s medical record to remind clinicians to discuss weight gain with them Sticker in hospital medical record

Methods Critical appraise this study using the Critical Appraisal Skill Programme checklist for Randomised Controlled Trials ( What are the strengths and weaknesses of this RCT? How do the demographics of the study participants compare to women in your practice (see Table 1)? Analysis of covariance (ANCOVA) was used to analyse the difference in gestational weight gain. What is ANCOVA and was its use appropriate?

Primary composite outcome Standard care (N = 184) Intervention (N = 187) Overall124 (67%)124 (66%) Gestational Diabetes MellitusYes35 (18.3%)37 (19.5%) No Unknown115 Gestational hypertension or pre- eclampsia 19 (10.3%)17 (9.1%) Mode of birthNormal95 (51.6%)98 (52.4%) Vaginal breech01 Vacuum assisted5 (2.7%) Forceps16 (8.7%)19 (10.1%) Emergency CS31 (16.8%)36 (19.3%) Elective CS37 (20.1%)28 (15.0%) Shoulder dystocia*5 (2.7%)3 (1.6%) 3 rd or 4 th degree tear*5 (2.7%)7 (3.4%) Postpartum haemorrhageN (%) > 1000 ml15 (7.8%)15 (7.9%) Maternal high dependency care for any reason 5 (2.7%) Maternal death00 * Percentage of women with vaginal delivery Results

There was no difference in GWG between women in the intervention and control groups QoL was assessed with the WHO-QOL BREF at 36 weeks gestation There was no difference between the two groups for physical, psychological, social or environmental sub-scales Secondary outcomes Gestational weight gain (GWG) and Quality of Life (QoL)

Results Are the outcomes of women who were overweight different from those who were obese (see supplementary figure S2 and S4)? How did the authors assess the impact of missing data (18%) in this study (see supplementary figure S3)?

Discussions How does this RCT enhance your practice, in view of the existing evidence (see suggested reading)? Which interventions to limit gestational weight gain may be of value for overweight or obese women during pregnancy (see suggested reading)?

Authors’ conclusion Simple, pragmatic intervention did not improve obstetric outcomes of overweight and obese pregnant women. However, women’s quality of life was not impaired by discussion about weight gain and encouragement to self-weigh themselves.

Suggested Reading Critical Appraisal Skill Programme (CASP). CASP checklist for Randomised Controlled Trials ( Thangaratinam S, et al. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ May 16;344:e2088. Brownfoot FC, Davey MA, Kornman L. Routine weighing to reduce excessive antenatal weight gain: A randomised controlled trial. BJOG Sagedal LR, Øverby NC, Bere E, Torstveit MK, Lohne-Seiler H, Småstuen M, Hillesund ER, Henriksen T, Vistad I. Lifestyle intervention to limit gestational weight gain: the Norwegian Fit for Delivery randomised controlled trial. BJOG

Authors’ Affiliations Elizabeth A. McCarthy a,b, Susan P. Walker a,b Antony Ugoni c Martha Lappas a Omega Leong b Alexis Shub a,b a University of Melbourne, Department of Obstetrics and Gynaecology, AUSTRALIA b Mercy Hospital for Women, 163 Studley Road, Heidelberg, Victoria 3084, AUSTRALIA c University of Melbourne, Department of Physiotherapy, Centre for Health, Exercise and Sports Medicine, Level 7, Alan Gilbert Building, Building 104, Victoria 3010, AUSTRALIA The authors have no conflicts of interest Corresponding author Dr E McCarthy