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

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Abstract

Background

Current 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/design

This 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/m ² 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.

Discussion

There 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 registration

ANZCTR, 12,614,001,160,628. Registered on 5 November 2014.

Electronic supplementary material

The online version of this article (10.1186/s13063-018-2615-6) contains supplementary material, which is available to authorized users.

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Most cited references 53

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The Hyperglycemia and Adverse Pregnancy Outcome Study

Patrick Catalano, H McIntyre, J. Kennedy Cruickshank … (2012)

OBJECTIVE To determine associations of gestational diabetes mellitus (GDM) and obesity with adverse pregnancy outcomes in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study. RESEARCH DESIGN AND METHODS Participants underwent a 75-g oral glucose tolerance test (OGTT) between 24 and 32 weeks. GDM was diagnosed post hoc using International Association of Diabetes and Pregnancy Study Groups criteria. Neonatal anthropometrics and cord serum C-peptide were measured. Adverse pregnancy outcomes included birth weight, newborn percent body fat, and cord C-peptide >90th percentiles, primary cesarean delivery, preeclampsia, and shoulder dystocia/birth injury. BMI was determined at the OGTT. Multiple logistic regression was used to examine associations of GDM and obesity with outcomes. RESULTS Mean maternal BMI was 27.7, 13.7% were obese (BMI ≥33.0 kg/m2), and GDM was diagnosed in 16.1%. Relative to non-GDM and nonobese women, odds ratio for birth weight >90th percentile for GDM alone was 2.19 (1.93–2.47), for obesity alone 1.73 (1.50–2.00), and for both GDM and obesity 3.62 (3.04–4.32). Results for primary cesarean delivery and preeclampsia and for cord C-peptide and newborn percent body fat >90th percentiles were similar. Odds for birth weight >90th percentile were progressively greater with both higher OGTT glucose and higher maternal BMI. There was a 339-g difference in birth weight for babies of obese GDM women, compared with babies of normal/underweight women (64.2% of all women) with normal glucose based on a composite OGTT measure of fasting plasma glucose and 1- and 2-h plasma glucose values (61.8% of all women). CONCLUSIONS Both maternal GDM and obesity are independently associated with adverse pregnancy outcomes. Their combination has a greater impact than either one alone.

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Cellular mechanisms for insulin resistance in normal pregnancy and gestational diabetes.

Linda A. Barbour, Carrie McCurdy, Teri Hernandez … (2007)

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Maternal body mass index and the risk of fetal death, stillbirth, and infant death: a systematic review and meta-analysis.

Dagfinn Aune, Ola Saugstad, Tore Henriksen … (2014)

Evidence suggests that maternal obesity increases the risk of fetal death, stillbirth, and infant death; however, the optimal body mass index (BMI) for prevention is not known. To conduct a systematic review and meta-analysis of cohort studies of maternal BMI and risk of fetal death, stillbirth, and infant death. The PubMed and Embase databases were searched from inception to January 23, 2014. Cohort studies reporting adjusted relative risk (RR) estimates for fetal death, stillbirth, or infant death by at least 3 categories of maternal BMI were included. Data were extracted by 1 reviewer and checked by the remaining reviewers for accuracy. Summary RRs were estimated using a random-effects model. Fetal death, stillbirth, and neonatal, perinatal, and infant death. Thirty eight studies (44 publications) with more than 10,147 fetal deaths, more than 16,274 stillbirths, more than 4311 perinatal deaths, 11,294 neonatal deaths, and 4983 infant deaths were included. The summary RR per 5-unit increase in maternal BMI for fetal death was 1.21 (95% CI, 1.09-1.35; I2 = 77.6%; n = 7 studies); for stillbirth, 1.24 (95% CI, 1.18-1.30; I2 = 80%; n = 18 studies); for perinatal death, 1.16 (95% CI, 1.00-1.35; I2 = 93.7%; n = 11 studies); for neonatal death, 1.15 (95% CI, 1.07-1.23; I2 = 78.5%; n = 12 studies); and for infant death, 1.18 (95% CI, 1.09-1.28; I2 = 79%; n = 4 studies). The test for nonlinearity was significant in all analyses but was most pronounced for fetal death. For women with a BMI of 20 (reference standard for all outcomes), 25, and 30, absolute risks per 10,000 pregnancies for fetal death were 76, 82 (95% CI, 76-88), and 102 (95% CI, 93-112); for stillbirth, 40, 48 (95% CI, 46-51), and 59 (95% CI, 55-63); for perinatal death, 66, 73 (95% CI, 67-81), and 86 (95% CI, 76-98); for neonatal death, 20, 21 (95% CI, 19-23), and 24 (95% CI, 22-27); and for infant death, 33, 37 (95% CI, 34-39), and 43 (95% CI, 40-47), respectively. Even modest increases in maternal BMI were associated with increased risk of fetal death, stillbirth, and neonatal, perinatal, and infant death. Weight management guidelines for women who plan pregnancies should take these findings into consideration to reduce the burden of fetal death, stillbirth, and infant death.

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Author and article information

Contributors

Sarah Price: sarah.price@unimelb.edu.au

Alison Nankervis: alison.nankervis@mh.org.au

Michael Permezel: m.permezel@unimelb.edu.au

Luke Prendergast: luke.prendergast@latrobe.edu.au

Priya Sumithran: priyas@unimelb.edu.au

Joseph Proietto: j.proietto@unimelb.edu.au

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 24 April 2018

Publication date PMC-release: 24 April 2018

Publication date Collection: 2018

Volume: 19

Electronic Location Identifier: 248

Affiliations

[1 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Department of Medicine, , University of Melbourne, Heidelberg Repatriation Hospital, ; Waterdale Rd., Heidelberg, VIC 3081 Australia

[2 ]Diabetes Service, University of Melbourne, Royal Women’s Hospital, Flemington Rd., Parkville, VIC 3050 Australia

[3 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Department of Obstetrics and Gynaecology, , University of Melbourne, Mercy Hospital for Women, ; Studley Rd.,, Heidelberg, VIC 3050 Australia

[4 ]ISNI 0000 0001 2342 0938, GRID grid.1018.8, Department of Mathematics and Statistics, , LaTrobe University, ; Kingsbury Drive, Bundoora, VIC 3081 Australia

[5 ]Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Grattan St.,, Parkville, VIC 3083 Australia

Article

Publisher ID: 2615

DOI: 10.1186/s13063-018-2615-6

PMC ID: 5926510

PubMed ID: 29690917

SO-VID: 37261762-52b2-4805-8ff2-a091ad62f8cf

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 18 May 2017

Date accepted : 28 March 2018

Funding

Funded by: Norman beischer medical research foundation grant

Funded by: National Health and Medical Research Council (AU)- Postgraduate scholarship

Award ID: APP1092805

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: pregnancy,pre-conception,obesity,weight loss,glucose metabolism,pregnancy outcomes,randomized trial

Data availability:

ScienceOpen disciplines: Medicine

Keywords: pregnancy, pre-conception, obesity, weight loss, glucose metabolism, pregnancy outcomes, randomized trial

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

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Abstract

Background

Methods/design

Discussion

Trial registration

Electronic supplementary material

Related collections

Karger: Nutrition and Dietetics

Most cited references 53

The Hyperglycemia and Adverse Pregnancy Outcome Study

Cellular mechanisms for insulin resistance in normal pregnancy and gestational diabetes.

Maternal body mass index and the risk of fetal death, stillbirth, and infant death: a systematic review and meta-analysis.

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