Pregnancy Outcomes after Pre-pregnancy weight loss in obese women (POP Study)

INTERVENTION: 12 week program which consists of: 1) Optifast meal replacement for 2 meals per day. The third meal consisting of a serve of protein (meat, chicken, egg, tofu approximately the size of the palm of the hand), 2 cups of non‐starch vegetables and a salad dressed with oil. Patients will meet with a dietician at the start of the study for 30 minutes to discuss implementation of the diet. They will then prepare meals themselves. Participants will be seen every 2 weeks during the intervention phase. Blood pressure, weight, waist circumference and hip circumference will be measured. 2)Exercise according to national guidelines. Patients will be asked to complete the 'Australia Active Survey' prior to commencing the study. They will then be provided with an information booklet "Australia's Physical Activity and Sedentary Behaviour Guidelines for Adults". These guidelines recommend accumulating 150 to 300 minutes (2 ½ to 5 hours) of moderate intensity physical activity or 75 to 150 minutes (1 ¼ to 2 ½ hours) of vigorous intensity physical activity, or an equivalent combination of both moderate and vigorous activities each week. Subjects will be provided with a Pedometer (Yamax 700S). Daily step count will be recorded for 7 consecutive days (week 2 of study). This is for the purposes of ensuring there is not a significant difference in activity level between our two study groups. 3) Pre‐pregnancy vitamin supplement including high dose folate. Folate 5mg orally, by mouth daily is recommended in accordance with the RANZCOG 'Obesity in Pregnancy' guidelines. In addition, participants will be asked to take a multi‐vitamin suitable for a woman planning pregnancy (eg. Elevit). Blood tests will be performed at the start and end of the intervention period. A food diary will be performed to ensure compliance with the diet. However, the amount of weight on on Optifast should be approximately 10‐15% of body weight in 12 weeks based on the results of previous trials. *Optifast products vary slightly but an example of the components of an Optifast product are listed below. Optifast products include soups, bars, desserts, shakes. INGREDIENTS NUTRITIONAL INFORMATION Servings per package 6 Serving size 60g Unit of measure Quantity per serve Energy kJ 950 Cal 228 Protein g 18.3 Fat, total g 6.9 ‐ Saturated fat g 2.6 Carbohydrates g 20.8 ‐ Sugar g 19.3 Dietary fibre g 4.5 VITAMINS Thiamin mg 0.69 Riboflavin mg 1.02 Niacin mgNE 9.6 Pantothenic acid mg 1.9 Vit B6 mg 1 Biotin microgram 67 Folic Acid microgram 126 Vit C mg 63 Vit E mgTE 6 MINERALS Sodium mg 390 Calcium mg 270 Copper mg 0.9 Iodine microgram 66 Iron mg 9.1 Magnesium mg 150 Manganese mg 0.70 Phosphorus mg 588 Selenium microgram 36 Zinc mg 5.4 Potassium mg 732 CONDITION: Obesity Pre‐pregnancy weight loss PRIMARY OUTCOME: In obese (BMI >30kg/m2) non‐diabetic women, does substantial pre‐conception weight loss (10‐15% body weight) result in a =/>10% reduction in maternal fasting plasma glucose (in mmol/L) at 26‐28 weeks gestation when compared with maternal fasting plasma glucose (in mmol/L)from women who achieve modest pre‐conception body weight (<3% body weight). SECONDARY OUTCOME: 4) Neonatal anthropometery ; ; Length will be measured in centimetres using a measuring board. ; ; Birth weight will be taken in grams within 72 hours of delivery using calibrated digital scales. ; ; Head circumference will be measured using a tape measure. Measurements will be taken be the same examiner. ; ; INCLUSION CRITERIA: Planning pregnancy in the next 6 months Fructose glucose syrup (sugar beet), Soy crisp (Soy protein isolate, tapioca starch, salt), Milk chocolate (17%) [Sugar, Cocoa solids (6.5%), whole Milk powder, Emulsifier (Soy lecithin), Flavour], Soy nuts, Soy protein isolate, Minerals (Tripotassium citrate, Calcium phosphate, Sodium phosphate, Magnesium phosphate, Trisodium citrate, Magnesium carbonate, Ferric pyrophosphate, Potassium iodate, Zinc oxide, Sodium selenate, Copper sulphate, Manganese sulphate), Inulin, Fruit preparation [ Sugar, Raspberry (0.6%), Apple puree (0.4%),Raspberry (0.6%) and Cherry (0.2%) juice concentrate, Fructose syrup, Lactose (9%) (Milk), Vegetable fat, Flavour, Vegetable gum (440), Food acid (330)], Vegetable oil (Rapeseed), Vitamins (Ascorbic acid, Vitamin E acetate, Nicotinamide, Biotin, Vitamin A acetate, Calcium pantothenate, Folic acid, Cholecalciferol, Pyridoxine, Riboflavin, Thiamin, Cyanocobalamin), Food acid (330), Flavour, Emulsifier (Soy lecithin). Contains Milk and Soy. Made on equipment that also processes products containing tree nuts, peanuts and oats. ; Skin fold thickness will be measured at each of three sites‐ left triceps, left sub scapular region and left flank. Each will be recorded in centimetres using Harpenden calipers. Measurements will be taken be the same examiner. ; In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the rate of gestational hypertension or pre‐eclampsia (defined as persistent hypertension that develops in pregnancy with involvement of one or more maternal system)? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the rate of maternal gestational diabetes (IADPSG definition)? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the rate of neonatal hypoglycaemia (neonatal blood glucose <2.6mmol/L within the neonatal period)? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the rate of neonates born prior to 37 completed weeks gestation? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the rate of primary caesarean section? ; In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the shoulder dystocia/birth injury? BMI equal or greater than 30 and equal or less than 55kg/m2 Living in Victoria Australia ; In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) reduce the time (in days) between the end of the weight maintenance phase and conception? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in rate of intra‐uterine growth restriction (IUGR) (defined as an estimated fetal weight <10th percentile for gestational age)? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in rate of large‐for‐gestational age infants (birth weight >90th gentile for gestational age)? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in rate of neonatal intensive care or special care nursery admission? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the composite end‐point of maternal gestational diabetes (IADPSG definition), large‐for‐gestational age, macrosomia, pre‐eclampsia, intra‐uterine growth restriction (IUGR), delivery prior to 37 weeks, caesarean section, shoulder dystocia/birth injury, neonatal hypoglycaemia, neonatal hyperbilirubinemia, neonatal intensive care or special care nursery admission. In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the end‐point of macrosomia (birth weight >4000g)? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in a reduction in the rate of clinically diagnosed neonatal hyperbilirubinemia? ; In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in an increase live birth rate? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight) when compared with modest pre‐conception weight loss (<3% body weight) result in no difference in gestational weight gain? In obese women (BMI >30kg/m2), does substantial pre‐conception weight loss (10‐15% body weight), when compared with modest pre‐conception weight loss (<3% body weight), result in a distinct pattern of DNA methylation in cells (cord blood and/or buccal mucosa) derived from the offspring? Maternal mean length of hospital stay Neonatal mean length of hospital stay