Health consequences for mother and baby of substantial pre-conception weight loss in obese women: study protocol for a randomized controlled trial

Abstract

BackgroundCurrent guidelines for the management of obesity in women planning pregnancy suggest lifestyle modification before conception. However, there is little evidence that lifestyle modification alters pregnancy outcomes. Bariatric surgery results in significant weight loss. This appears to reduce the risk of adverse pregnancy outcomes for the mother but may increase the risk of adverse outcomes for the infant. In order to reduce the risks of obesity-related adverse pregnancy outcomes for both mother and offspring, alternative approaches to the management of obesity in women planning pregnancy are needed.Methods/designThis study, a two-arm, parallel group, randomized control trial, will be conducted at the Metabolic Disorders Centre, University of Melbourne. This trial will recruit 164 women aged 18–38 years with a body mass index of 30–55 kg/m2 who plan to conceive in the next 6–12 months. Women will be randomized to one of two 12-week interventions (Group A and Group B). Group A will aim for modest weight loss (MWL; ≤ 3% body weight) using a hypocaloric diet. Group B will aim for substantial weight loss (SWL; 10–15% body weight) using a modified very low energy diet (VLED) program. All participants will be asked to comply with National Health and Medical Research Council (NHMRC) guidelines for exercise and will be provided with standard pre-pregnancy advice according to Royal Australian and New Zealand College of Obstetrics and Gynaecology guidelines. All participants will then be observed for the subsequent 12 months. If pregnancy occurs within the 12-month follow-up period, data on weight and metabolic status of the mother, and pregnancy outcomes of mother and offspring will be recorded.The primary outcome is maternal fasting plasma glucose at 26–28 weeks’ gestation, given that this is known to correlate with pregnancy outcomes. Time to conception, live birth rate, gestational weight gain, and a composite of adverse pregnancy outcomes for mother and baby will comprise the secondary outcomes.DiscussionThere is increasing emphasis on obese women losing weight before conception. To date, no randomized controlled trial has demonstrated an effective means of weight loss that results in improved pregnancy outcomes for both mother and baby. This study intends to determine if substantial pre-conception weight loss, achieved using a VLED, improves pregnancy outcomes for mother and baby when compared with standard care. This research will potentially change clinical care of an obese woman planning pregnancy.Trial registrationANZCTR, 12,614,001,160,628. Registered on 5 November 2014.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2615-6) contains supplementary material, which is available to authorized users.

Effect of Birthing Ball Exercises during Pregnancy on the First Stage Progress of Labor

“…On the other hand, regarding maternal body mass index at delivery the prevalence of maternal overweight and obesity is increasing and has important consequences for the health of mother and child at delivery (Price et al, 2018). In the present study percentage of obese women in control group was about one third of the mind it was significantly greater than in intervention group.…”

The Effect of Balanced Hypocaloric Diet on the Anthropometric and Basic Metabolic Indicators in Infertile Women with Gluteofemoral Obesity

“…However, to date, not a single randomized controlled trial has demonstrated effective means of weight loss, which lead to improved pregnancy outcomes for both mother and baby. An ZCTR study is currently registered in Australia, which aims to determine the best approach to weight loss during pregnancy planning [32] The study will include 164 patients with a BMI of 30 -55 kg/m 2 . Patients will be divided into two groups: the first-patients in whom a slight decrease in body weight by 3% -5% s is planned using a moderately hypocaloric diet for 12 months, the second-patients who are planning a significant reduction in body weight by 10% -15% using a modified pronounced low-energy diet [32].…”

Implantation and the Fetal Health

“…Recent findings have demonstrated that perturbations of the maternal physiology during the peri-conceptional period (e.g., maternal diet) have impact both on preimplantation phenotype and long-term development and could lead to impaired health during adulthood [26]. Emerging evidence suggests the metabolic status of the mother may "program" the offspring's long-term risk of metabolic disease [27].…”