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This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2013, Issue 1
http://www.thecochranelibrary.com
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . .
APPENDICES . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . .
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
INDEX TERMS
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Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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[Intervention Review]
of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK. 2 NIHR School for Primary Care
Research, Manchester Academic Health Science Centre, Institute of Population Health, University of Manchester, Manchester, UK.
3 Health Sciences Primary Care Research Group, The University of Manchester, Manchester, UK. 4 Clinical Sciences Research Institute,
University of Warwick, Coventry, UK
Contact address: Christine M Furber, School of Nursing, Midwifery and Social Work, The University of Manchester, Jean McFarlane
Building, Oxford Road, Manchester, M13 9PL, UK. christine.furber@manchester.ac.uk.
Editorial group: Cochrane Pregnancy and Childbirth Group.
Publication status and date: New, published in Issue 1, 2013.
Review content assessed as up-to-date: 16 November 2012.
Citation: Furber CM, McGowan L, Bower P, Kontopantelis E, Quenby S, Lavender T. Antenatal interventions for reducing weight in
obese women for improving pregnancy outcome. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD009334. DOI:
10.1002/14651858.CD009334.pub2.
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Being obese and pregnant is associated with substantial risks for the mother and her child. Current weight management guidance for
obese pregnant women is limited. The latest recommendations suggest that obese pregnant women should gain between 5.0 and 9.1
kg during the pregnancy period, and weight loss is discouraged. However, observational studies indicate that some obese pregnant
women, especially those who are heavier, lose weight during pregnancy. Furthermore, some obese pregnant women may intentionally
lose weight. The safety of weight loss when pregnant and obese is not substantiated; some observational studies suggest that risks
associated with weight loss such as pre-eclampsia are improved, but others indicate that the incidence of small- for-gestational infants
are increased. It is important to evaluate interventions that are designed to reduce weight in obese pregnant women so that the safety
of weight loss during this period can be established.
Objectives
To evaluate the effectiveness of interventions that reduce weight in obese pregnant women.
Search methods
We searched the Cochrane Pregnancy and Childbirth Groups Trials Register (31 July 2012) and contacted experts in the field.
Selection criteria
Randomised controlled trials, quasi-random studies and cluster-randomised trials comparing a weight-loss intervention with routine
care or more than one weight loss intervention. Cross-over trials were not eligible for inclusion.
Data collection and analysis
We identified no studies that met the inclusion criteria for this review.
Main results
There were no included trials.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Authors conclusions
There are no trials designed to reduce weight in obese pregnant women. Until the safety of weight loss in obese pregnant women
can be established, there can be no practice recommendations for these women to intentionally lose weight during the pregnancy
period. Further study is required to explore the potential benefits, or harm, of weight loss in pregnancy when obese before weight loss
interventions in pregnancy can be designed. Qualitative research is also required to explore dietary habits of obese pregnant women,
especially those who are morbidly obese.
BACKGROUND
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
OBJECTIVES
Why it is important to do this review
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
METHODS
Types of studies
We considered all published and unpublished randomised and
quasi-randomised controlled trials, comparing a weight loss intervention with routine care or more than one weight loss intervention. We considered cluster-randomised trials.
Neonatal outcomes
1. Birthweight less than 2500 g and less than the 10th centile
for gestational age and sex.
2. Birth weight greater than 4000 g or larger than the 90th
centile for gestational age and sex.
3. Preterm birth (birth less than 37 completed weeks of
pregnancy).
4. Apgar scores less than seven at five minutes.
5. Hypoglycaemia - as defined by trialists.
Long-term outcomes
1. Maternal weight postpartum.
2. Childhood weight.
Types of participants
Obese pregnant women with a BMI equal to, or greater than 30
(kg/m).
Types of interventions
Electronic searches
Primary outcomes
Secondary outcomes
Maternal outcomes
1. Gestational diabetes.
2. Fetal distress in pregnancy or labour.
3. Postpartum haemorrhage.
4. Caesarean birth.
5. Infection (including wound, urinary tract, perineum, chest
and breast).
6. Weight (loss/gain/no change).
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Selection of studies
Three review authors (Christine Furber, Tina Lavender, and Linda
McGowan) independently assessed for inclusion each study that
was identified through the search strategy. We resolved any disagreement through discussion.
In this version of the review we did not identify any studies for
inclusion. In updates of the review if we do identify trials which
meet our inclusion criteria we will use the methods set out in
Appendix 1 to carry out data extraction, assess bias in included
studies and analyse findings.
RESULTS
Description of studies
See: Characteristics of excluded studies.
See Characteristics of excluded studies.
The search of the Cochrane Pregnancy and Childbirth Groups
Trials Register retrieved 63 reports equating to 49 studies. We
applied the eligibility criteria to each study and all were excluded.
In some situations, we emailed the authors of the study to clarify
the overall aim of the study. None of the studies identified aimed
to reduce weight in obese pregnant women. See Excluded studies.
DISCUSSION
This review indicates that obesity in pregnancy is of international
concern; most of the studies retrieved from the searches were
from Europe, North America, the Nordics, and Australia and New
Zealand, and a few were conducted in Brazil and Egypt. However, no randomised controlled trials designed to reduce maternal
weight in pregnant obese women were found. The majority of the
excluded randomised controlled trials including obese pregnant
women that were reviewed had outcomes which aimed to manage maternal weight gain within the parameters of the Institute
of Medicine Guidance (Medicine 1990), or to reduce excessive
weight gain. Others were designed to improve dietary and exercise behaviours, reduce infant weight, explore pregnancy outcome,
and minimise the effects of diabetes. A range of interventions were
included in these studies including dietary, exercise, and comprehensive lifestyle interventions. Others included interventions that
incorporated practices in the delivery of maternity care including
regular maternal weighing in pregnancy, and continuity in the delivery of maternity care. Pharmacological agents were used in some
studies, but they were not used to reduce weight. Furthermore, two
studies that used pharmacological interventions did not include
obese women. Metformin is currently being used in two studies to
minimise adverse outcomes for obese pregnant women (Norman
2010; Shehata 2012), however, weight loss is not a planned outcome.
From retrospective cohort observational studies (Beyerlein 2011;
Blomberg 2011; Oken 2009) for example, it is clear that weight
loss when obese in pregnancy is not unusual, whether this is intentional or not. Weight loss when obese should be monitored
carefully as although emerging observational studies of existing
data indicate that there are some improvements in outcomes such
as incidence of pre-eclampsia, caesarian section and adverse outcomes at birth for the mother and infant, the increase in small-forgestational-age infants is of concern (Beyerlein 2011; Blomberg
2011).
Excluded studies
None of the studies retrieved aimed to reduce weight in obese
pregnant women so were not relevant to this review. In total, 38
of the 49 studies retrieved reported results of trials. Eight trials
were excluded as the participants were either not pregnant (two
studies), or not obese (six studies).
AUTHORS CONCLUSIONS
Risk of bias in included studies
No studies met the eligibility criteria for inclusion.
Effects of interventions
No studies met the eligibility criteria for inclusion.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ACKNOWLEDGEMENTS
As part of the pre-publication editorial process, this review has
been commented on by four peers (an editor and three referees
who are external to the editorial team) and the Groups Statistical
Adviser.
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Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
10
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World Health Organization 2006
World Health Organization. Overweight and Obesity. Fact
sheet N311. Geneva: WHO, 2006.
Zaninotto 2006
Zaninotto P, Wardle H, Samakakis E, Mindell J, Head
J. Forecasting Obesity to 2010. London: Department of
Health, 2006.
Zhang 2007
Zhang J, Bricker L, Wray S, Quenby S. Poor uterine
contractility in obese women. BJOG: an international
journal of obstetrics and gynaecology 2007;114:3438.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
14
CHARACTERISTICS OF STUDIES
Study
Althuizen 2006
This paper is a protocol of a study in The Netherlands. The intervention (the New Life(style) intervention
program) is not aimed at reducing weight in obese women, but at helping pregnant women to gain weight
within IOM guidelines. The authors were emailed (March 2012) and they confirmed that the study is now
complete. The author confirmed that the study was not aimed at obese women although there were no weight
restrictions on recruitment. Of the 250 women in the sample, only 8 were obese
Angel 2011
This is a brief conference abstract of a randomised controlled trial in the US. The intervention did not aim to
reduce weight in obese pregnant women so has been excluded
Asbee 2009
Brief conference abstract of a randomised controlled trial in the US. This Intervention did not aim to reduce
weight in obese pregnant women but prevent excessive weight gain. It is also not clear whether the participants
were obese or not
Badrawi 1993
This Intervention did not aim to reduce weight in obese pregnant women but to investigate pregnancy outcome
when obese pregnant women were given either a 1500-2000 Kcal daily diet compared to a diet of no restriction.
The abstract reports that those on an unrestricted diet had a high rate of weight gain but there is no information
about the intervention group weight. The study is excluded as the intervention did not aim to reduce maternal
weight
Boileau 1968
This report of a randomised controlled trial in Canada included an intervention that did not aim to reduce
weight in obese pregnant women, but to evaluate the anorexic efficacy of Diethylproprion hydrochloride in
continuous release formulation. Some participants lost weight in the data. It is not clear if these women were
obese when they commenced the study as BMI was not reported. Maternal weight on entry to the study was
assessed using the authors office standard of more than 2-3 pounds per month
Brand-Miller 2011
The intervention will not aim to reduce weight so is not applicable to this review. The intervention is a low
glycaemic diet compared with a whole grain diet. The aim of the study is to compare the effects of the two diets.
Accessed from the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN1261000001055).
Brownfoot 2011
The intervention is maternal weight measurement recordings during routine antenatal care compared with
antenatal care that does not include weighing. The aim is to evaluate whether weighing at each antenatal visit
reduces excessive weight gain in pregnancy. It is not clear if obese pregnant women will be directly targeted for the
study. As the intervention does not aim to reduce maternal weight in obese women in pregnancy, it is excluded.
Accessed from the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12610000331033).
Callaway 2010
The intervention was a highly supported individualised exercise intervention versus usual activity. The intervention was not designed to reduce weight in obese pregnant women so is not relevant for this review. Although
the participants were reported as being obese, changes to weight or BMI are not reported in the study. The study
was a pilot to explore the feasibility of an individualised exercise programme to prevent gestational diabetes in
obese pregnant women
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
Chasen-Taber 2011
The intervention was a highly supported individualised exercise intervention versus provision of a booklet
about health and wellness in pregnancy. The intervention was not designed to reduce weight in obese pregnant
women so is not relevant for this review. Although the participants were reported as being obese, changes to
weight or BMI are not reported in the study. The study was a pilot to explore the feasibility of an individualised
exercise programme to prevent gestational diabetes in obese pregnant women. This study was completed in
the US
Dodd 2011
The intervention consists of comprehensive diet and lifestyle advice based on behavioural techniques delivered
by a dietician and trained researchers. Dietary advice will be based on current Australian guidelines. The control
group receive usual antenatal care. A power calculation indicates that 2180 women are required for the study.
The authors were emailed March 2012 who confirmed that the study is now complete and results will be
published in approximately 1 year. The study is excluded as the intervention does not aim to reduce weight in
obese pregnant women
Faucher 2008
This is a conference abstract. The abstract describes a pilot intervention in portion control that is aimed to
lead to weight loss in low-income women. It is not clear if the women were obese. It is clear that pregnant
women were not included in the study. The abstract is excluded as the participants were not pregnant
Guelinckx 2010
This is a randomised controlled trial including 195 obese pregnant women conducted in Belgium. Women
were randomised to 1 of 3 groups: nutritional advice from a brochure versus brochure and lifestyle advice from
a nutritionist versus usual care. Outcomes were dietary habits, physical activity, weight gain in pregnancy and
obstetric and neonatal outcomes. It is reported in the paper that gestational weight gain was not significantly
different between the groups, and did not decrease in the 2 intervention groups. The study is excluded as the
intervention did not aim to reduce weight in obese pregnant women
Haakstad 2011
This is a randomised controlled trial - assessor blinded carried out in Norway. The participants were sedentary,
nulliparous pregnant women - obese women were not directly targeted but 11 of the 105 participants were
obese. The intervention was an exercise group versus usual care. The outcomes were maternal weight gain and
proportion of women gaining above the IOM guidelines.The results indicate that there was no difference in
maternal weight gain between both groups. The study is excluded as the intervention did not aim to reduce
weight in obese pregnant women, but to prevent excessive weight gain
Harrison 2011
This was a brief conference abstract of a randomised controlled trial in Australia. The intervention was a low
intensity lifestyle designed to reduce excessive weight gain, not reduce weight, in overweight pregnant women.
The outcome was to assess the efficacy of the intervention, therefore the study has been excluded
Huang 2011
This is a randomised controlled trial in Taiwan. The participants were all pregnant women (n = 240), including
some who were obese.The intervention included individual counselling about diet and physical exercise over
2 time periods. 1 group through pregnancy till 6 months postpartum, and the other from birth till 6 months
postpartum. The aim of the study was to explore the effect of the interventions on weight retention. The results
indicate that the intervention is effective for reducing postpartum weight retention. However, the study did
not aim to reduce weight in obese pregnant women, so it has been excluded
Hui 2012
This is a randomised controlled trial in Canada. The intervention aimed to explore the effect of an exercise and
dietary intervention on excessive gestation weight gain. The participants (n = 190) were non-diabetic pregnant
women (88 in the control group and 102 in the intervention group). Women of all BMI were recruited and
the results indicated that the intervention reduced excessive gestational weight gain. As the study did not aim
to reduce weight in obese pregnant women, it is excluded
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
Jackson 2011
This is a randomised controlled trial including pregnant women of all BMI, recruited before 26 weeks of
pregnancy, n = 327 (163 in the intervention and 164 usual care). The study was conducted in the US.
The intervention was called Video Doctor - messages about diet, exercise and weight gain delivered by
actor portrayed DVD delivered on a laptop in the clinic setting versus usual care. The primary outcome was
improvements in womens diet and exercise behaviours, and weight gain was a secondary outcome. The results
indicate that there were statistically significant increases from baseline in exercise undertaken and consumption
of healthy foods, and significant decreases in unhealthy foods. There was no difference in weight gain between
the groups. The intervention did not aim to reduce weight in obese pregnant women and so has been excluded
Jeffries 2009
This is a randomised controlled trial including pregnant women of all BMI, recruited at 14 weeks of pregnancy,
n = 236 (46 of participants had BMI > 29 kg/m2 ). The study was conducted in Australia.The intervention
was a personalised weight measurement card and advice about optimal weight gain in pregnancy with advice
to self-record weight at 4 weekly intervals versus standard antenatal care. All women were weighed at 36 weeks
using the same hospital scale. Participants were blinded to the purpose of the study.The primary outcome was
weight gain from recruitment till 36 weeks of pregnancy. The results indicate that there was a trend of less
weight gain in the intervention group in all BMI categories of participants, except for those with a BMI >
29 kg/m2 . The intervention did not aim to reduce weight in obese pregnant women, but to reduce excessive
weight gain and so has been excluded
Koushkie 2003
This is a brief conference abstract describing a randomised controlled trial designed to assess the effect of an
aerobic exercise programme started in the third trimester on pregnancy outcomes. The participants were 26
pregnant women. It is not clear whether they were obese or not. The outcomes were gestational age, gestational
pregnancy weight gain, and changes in triceps skin thickness. The results indicate that there were no significant
differences between groups. No other publications related to this study have been found. The intervention did
not aim to reduce weight in obese pregnant women, and so has been excluded
Krummel 2009
This study was accessed from the ClinicalTrials.gov where it states that the trial started April 2009 in the US
(NCT00865683). The randomised trial will recruit pregnant women with a BMI greater than 25, however,
it is not clear how many are to be included in the study. The intervention is a nutritional supplement,
docosahexaenoic acid (DHA) versus placebo. The primary outcome is insulin sensitivity measured at month
3. Secondary outcome is interleukin - 6 (IL-6) measured at month 3. The authors have been emailed to find
out more about the study but no reply has been obtained. As the intervention is not designed to reduce weight
in obese pregnant women, the study is excluded
Lavender 2011
This is a pilot randomised controlled trial accessed from Current Controlled Trials (ISRCTN09432573). The
study was conducted in the UK. The intervention is a 10-week lifestyle programme incorporating behaviour
change theory versus routine maternity care. 72 participants are to be recruited. The study is designed to explore
the feasibility and acceptability of the study, and the health of participants. Weight loss is not an outcome.
The intervention did not aim to reduce weight in obese pregnant women, and so has been excluded
Lombard 2011
This is brief conference abstract of a randomised controlled trial from Australia. The intervention was the
delivery of a self-management lifestyle plan with advice to self-weigh (n = 106). The control group (n = 99)
received normal advice about diet and exercise, and no recommendations to weigh themselves. The participants
(n = 205) were pregnant women with BMI greater than 25 kg/m2 , or 23 kg/m2 if they were high risk
according to their ethnic identity. The results indicated that self-weighing has an effect on less weight gain
when incorporated with a self-management lifestyle intervention. However, as the intervention was not aimed
to reduce weight in obese pregnant women, it is not included in this review
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
Louie 2011
This was a randomised controlled trial in Australia. The aim of the study was to investigate the effectiveness
of a low glycaemic versus a high fibre diet on pregnancy and neonatal outcome in women diagnosed with
gestational diabetes mellitus in pregnancy. The outcomes were birthweight, infant parameters, and serum
glucose levels. However, none of the participants recruited were obese at recruitment according to the paper
so the study is excluded
Luoto 2011
This is a cluster-randomised controlled trial in Finland. The intervention included an individualised counselling
programme from weeks 12 to 37 of pregnancy. The counselling involved advice on physical activity, diet and
weight gain in pregnancy. The participants were pregnant women with a high risk of developing gestational
diabetes mellitus and included those with BMI > 25 kg/m2, those with gestational diabetes mellitus or any sign
of glucose intolerance, and those with neonatal macrosomia in past pregnancies. Women who had a family
history of diabetes were also eligible. The primary outcome was the proportion of women who had gestational
diabetes mellitus at 28 weeks of pregnancy and neonatal macrosomia. The secondary outcome was maternal
weight gain. The intervention did not aim to reduce weight in obese women so has been excluded from the
review
Magee 1990
This study is a small randomised controlled trial in the US. The 12 participants were all pregnant women
diagnosed with gestational diabetes mellitus and a prepregnancy weight greater than 120% than their ideal
weight. The study involved hospitalisation for 2 weeks and all participants consumed the same 2400 calorie/
day diet for 1 week. During week 2, the intervention group consumed 1200 calories/day and the control group
carried on with the same 2400 calorie/day diet. The aim of the study was to examine the efficacy of lowering
plasma glucose levels and to better understand metabolic changes in obese women with gestational diabetes
mellitus. Outcomes measurements were serum glucose and other biomarkers relevant to diabetes. At the end
of the study, The results indicated that there was an improvement in glycaemic status in diets of 1200 calories/
day in obese pregnant women with gestational diabetes, but these diets also cause significant ketonemia and
ketonuria. As the intervention did not aim to reduce weight in obese pregnant women, it is excluded
Moholdt 2011
This paper is a protocol of a randomised controlled trial in Norway. The study is ongoing and expected to
be completed end of 2012. The participants will be obese pregnant women (n = 150) and the intervention
is an organised exercise programme designed for pregnant women; the control group will have usual care.
The primary outcome is to reduce weight gain in pregnancy, not reduce weight, hence the study will not be
included in this review
Moses 2006
This study was a parallel controlled trial in the US, where participants were assigned alternatively to each
group. Randomisation did not occur as the participants were alternately assigned to 1 of 2 diets. One diet was
a low glycaemic (carbohydrate) diet and the other a high fibre with moderate - high glycaemic index. Healthy
pregnant women were recruited however, none of the participants were obese. The study has been excluded as
this was not a randomised controlled trial, the participants were not obese and the study did not aim to reduce
weight
Moses 2009
This is a randomised controlled trial in the US. The study included 63 pregnant obese women who were
diagnosed with gestational diabetes mellitus between 28 and 32 weeks of pregnancy. The aim of the study was
to assess whether a low-glycaemic index diet in women with gestational diabetes mellitus reduced the need for
insulin with no compromise on obstetric and fetal outcomes. Maternal weight gain and ponderal index and
obstetric outcomes of induction, birth mode, gestational age, and fetal outcomes of birthweight were assessed.
The results indicated that there was no significant differences between groups in all outcomes. The outcomes
were not related to reducing weight in obese pregnant women so the study has been excluded
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
Nagle 2011
This paper is a protocol of a randomised controlled trial in Australia. The participants will be obese primigravid
pregnant women and the intervention will be continuity of midwifery care (care delivered by a small group of
midwives) in pregnancy versus usual care The study aims to compare both patterns of maternity care provision
on restricting excessive weight gain in pregnancy. The outcomes will be gestational weight gain, womens
experience of care, satisfaction with care, psychological factors in pregnancy and readiness to change lifestyle.
As the study will not aim to reduce weight in obese pregnant women, it is excluded
Nascimento 2011
This is a randomised controlled trial from Brazil. The participants were 82 pregnant women with BMI greater
than 26 kg/m2 . 42 women were randomised to the intervention group of exercise under supervision, and
another 40 women had usual care in the control group. The primary outcome was an evaluation of weight
gain, not weight reduction, and secondary outcomes included perinatal outcomes such as mode of birth and
birthweight. The results illustrated that the exercise programme was not associated with managing weight gain
across all weights, however, for those who were in the overweight category, there were some benefits in relation
to lowering gestational weight gain. This study has been excluded as the aim was not to reduce weight in obese
pregnant women
Norman 2010
This is a multi-centre randomised controlled trial accessed from Current Controlled Trials (ISRCTN51279843), known as EMPOWaR. The aim of the study is to explore if metformin given to obese
pregnant women will reduce the future life risk of obesity and metabolic syndrome in babies. The participants
will be Caucasian obese pregnant women. The intervention is metformin given 3 times daily to a maximum
of 500-2500 mg each day versus placebo. The primary outcome is birthweight centiles of the baby, correlation
of maternal insulin resistance assessed at 36 weeks gestation, and adverse pregnancy outcomes. Although the
secondary outcomes include maternal anthropometry measures the study does not aim to reduce weight in
obese pregnant women. The study is therefore excluded
Ong 2009
This small randomised controlled trial in Australia aimed to explore the impact of a home-based supervised
exercise programme (use of a stationary exercise cycle) over 10 weeks in pregnancy on glucose tolerance
and anaerobic fitness in previously sedentary obese women. The control group continued with their normal
activities. The outcomes were body mass, glucose and insulin responses and aerobic fitness. The results indicated
that regular aerobic exercise may have favourable effects on glucose tolerance and aerobic fitness in obese
pregnant women. However, the study did not aim to reduce weight in obese pregnant women, so is excluded
Parat 2009
This study was accessed from ClinicalTrials.gov (NCT00804765). The study is in France and is a randomised
controlled trial where the intervention is educational sessions at 20, 28 and 35 weeks of pregnancy and then
at 2 months following the birth. The education sessions provide advice on healthy eating and modest exercise.
The control group has usual care and 1 dietary counselling session at 26 weeks of pregnancy. The participants
will be women with a BMI > 25 kg/m2 and it is expected that 800 will be recruited. The primary outcome
is 30% reduction in infant weight gain at 2 years. Secondary outcomes are reduction in rapid weight gain
from 0-6 months, reduction in children with BMI > 19 kg/m2 at 2 years, reduction in incidence of pregnancy
complications and macrosomia, spontaneous feeding at 4 months, increase in breastfeeding, reduction in
maternal BMI at 1 and 2 years after the birth, and reduction in serum lipid and glycaemia at 2 years after the
birth. The authors have been emailed to ask for further information about the intervention, and whether it is
aimed at reducing weight in obese women, and there has been no reply. The study has been excluded as the
intervention does not clearly state that it is aimed at reducing weight in obese pregnant women
Phelan 2011
This was a randomised controlled trial aimed at decreasing the proportion of pregnant women who exceeded
1990 IOM guidelines for gestational weight gain and to increase the proportion of women who had reached
their pre gravid weight at 6 months after the birth of their babies. The intervention was a behavioural-based
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
educational package designed to prevent excessive weight gain in pregnancy versus usual care. The study was
completed in the US. 400 women were recruited. The primary outcomes were the proportion of pregnant
women with an excessive weight gain based on the 1990 IOM guidelines and proportion of women below
their pre gravid weight 6 months after the birth. The study did not aim to reduce weight in obese pregnant
women, so is excluded from the review
Polley 2002
This study is a randomised controlled trial aimed at exploring whether a stepped-care behavioural lifestyle
intervention incorporating information about weight gain in pregnancy, healthy exercise and eating will reduce
excessive weight gain in pregnancy. The study was completed in the US. 120 pregnant women with a BMI > 19.
8 kg/m2 participated. The primary outcome was the proportion of women who exceeded the IOM guidelines
in relation to weight gain in pregnancy. The secondary outcomes were to evaluate the effects on total weight
gain, weight gain from recruitment to birth, and after the birth, weight loss and weight retention. The results
were stratified according to BMI and indicated that normal - weight women were less likely to exceed the IOM
guidance in relation to weight gain in pregnancy (P < 0.05), but in the overweight women (BMI > 26.0 kg/m2 )
there was a non-significant trend (P = 0.09) in the opposite direction where 59% of those in the intervention
group gained weight in excess of the IOM guidelines compared to 32% in the control group. The study did
not aim to reduce weight in obese pregnant women, so is excluded from the review
Poston 2009
This is a randomised controlled trial accessed from the Current Controlled Trials (ISRCTN8997135). The
study is being conducted in the UK. The goal of the study is to develop an intervention (individualised
pregnancy activity and diet programme) that will improve maternal glucose sensitivity in obese pregnant
women carrying a singleton fetus and lead to minimising maternal, fetal and neonatal complications. One
hundred pregnant women are to be included. The study does not aim to reduce weight in obese pregnant
women, so is excluded from the review
Quinlivan 2011
This was a randomised controlled trial of a 4-stepped multidisciplinary intervention including a food technologist and clinical psychologist in pregnancy versus usual antenatal care. The study was completed in Australia.
The aim of the study was to evaluate if the intervention would reduce the incidence of gestational diabetes
mellitus. The participants were 134 overweight and obese pregnant women. The primary outcome is prevalence of gestational diabetes mellitus and decreased gestational glucose tolerance. The secondary outcomes are
weight gain in pregnancy and birthweight. There was a significant decrease in incidence of gestational diabetes
mellitus (P =< 0.04) and reduction in weight gain in pregnancy (P < 0.0001) in the intervention group. The
study did not aim to reduce weight in obese pregnant women, so is excluded from the review
Rae 2000
This was a randomised controlled trial conducted in Perth, Australia. The participants were pregnant women
who were > 110% of ideal body weight for their height (where a BMI of 25 kg/m2 was considered equal to
100% of their ideal body weight) n = 117, 63 in the intervention and 54 in the control group. The intervention
was a moderately energy restricted diabetic diet providing 1590-1776 kilocalories a day (70% of recommended
dietary intake in Australia). The control group followed a diabetic diet that was not energy restricted and
provided 2010-2220 kilocalories a day. The aim of the study was to determine the effect of a 30% maternal
dietary energy restriction on the need for maternal insulin and incidence of macrosomia. Outcomes were
weight gain, energy intake, blood glucose levels, birthweight, gestation at birth, mode of birth. It is reported
that more women in the intervention group lost weight than those in the control group although this is not
statistically significant. The mean weight lost in the intervention group was 1.68 kg (SE 0.33, range 7.50-0.
00), and 1.68 kg (SE 0.32, range 5.00-0.00) in the control group. The author of the study was emailed to
confirm the aim of the study. The study did not aim to reduce weight in obese pregnant women so has been
excluded from the study
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
Rhodes 2010
This study was a randomised controlled trial in the US. The participants were 46 overweight and obese pregnant
women (BMI were > 25 kg/m2 and < 45 kg/m2 ). The intervention group were allocated to a low fat diet and
control group, a low glycaemic diet. The primary outcome was birthweight and secondary outcomes were
maternal weight gain and body composition, presence of maternal cardiovascular disease risk factors, gestational
length and infant anthropometric measurements. The results indicate that there were no significant differences
between maternal weight or maternal anthropometric measurements at 36 weeks. There were no significant
differences in birthweight although infant skinfold thickness measurements were lower (not significant) in the
low glycaemic diet group. The principal investigator was contacted to clarify if maternal weight reduction was
an outcome and this correspondence confirmed that weight gain was a secondary outcome. As maternal weight
reduction was not an outcome, the study has been excluded
Santos 2005
This study was a randomised controlled trial in Brazil. The intervention was supervised physical exercise of
60 minutes duration carried out 3 times weekly. The control group took part in once a week relaxation and
light stretching sessions. Altogether, 92 healthy pregnant women with BMI from 26-31 kg/m2 participated (46
in each group). The primary outcome was submaximal exercise capacity that was assessed by oxygen uptake
at the anaerobic threshold after 12 weeks of completion. Secondary outcomes included respiratory exchange
ratio, carbon dioxide output and heart rate at the anaerobic threshold. Birth weight was also assessed. The
intervention was not designed to reduce weight in obese women so has been excluded from the review
Shehata 2012
This is a randomised controlled trial accessed from ClinicalTrials.gov (NCT01273584). The study is being
conducted in the UK and recruitment of 850 pregnant women with BMI > 35 kg/m2 commenced Autumn
2010 and continues till Autumn 2014. The intervention includes metformin three times day with each meal
whilst the control group is a placebo. The primary outcome is birth weight and secondary outcomes include
maternal weight gain, development of gestational diabetes and hypertension, incidence of caesarean section,
post partum haemorrhage and neonatal complications such as preterm birth. The study does not aim to reduce
weight in obese pregnant women, so is excluded from the review
Silverman 1971
This was a randomised controlled trial (double blinded) in the US. The intervention was an appetite depressant
drug diethylpropion hydrochloride and the control was a placebo.The study included 75 pregnant women who
were described as overweight, or gaining weight excessively. Each participant was prescribed a 1500 calorie diet.
However, calculation of the BMI from the mean weight and height reported in the paper of the 75 participants
indicated that these were not obese (22 kg/m2 in the intervention group and 23 kg/m2 in the control group).
As the participants were not obese, the study is excluded
Szmeja 2011
This is a brief abstract of a randomised controlled trial with overweight and obese pregnant women (n = 193)
carried out in Australia. The intervention was a DVD incorporating dietary advice. The outcome measures
were self-reported knowledge and satisfaction with care. The study was not aiming to reduce weight in obese
pregnant women, hence is not included in this review
Te Morenga 2010
This study was a randomised controlled trial. Although the interventions were aiming to reduce weight in
obese women, the participants in the study were not pregnant. Hence the study has been excluded
Teede 2011
This is brief conference abstract of a randomised controlled trial in Australia. 228 overweight women at risk
of developing gestational diabetes mellitus were recruited. The intervention was a 4-phase lifestyle behavioural
programme aimed to increase physical activity and the control group participants received 1 physical activity
session. The primary outcome was optimising physical activity.The preliminary results indicate that this behavioural intervention in pregnancy may help minimise decline in physical activity in pregnancy compared to
information on its own. However, this study was not aiming to reduce weight in obese pregnant women so
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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(Continued)
This study was a randomised parallel-group controlled trial carried out in the US. The participants were
232 healthy pregnant obese women who were randomised into 2 groups. Exclusion criteria included women
suffering from medical complications including pre-existing diabetes. The intervention group followed a diet
similar to that provided to women who would have been diagnosed with diabetes mellitus (minimum of 2000
calories a day). The control group followed conventional dietary management. The objectives of the study were
to compare perinatal outcomes between groups, determine the effects of weight stabilisation between groups,
determine perinatal differences in the intervention group between adherence and non-adherence, evaluate
perinatal outcomes in women who gained less than 15 pounds, and those who gained more than 15 pounds
across both groups. The results indicated that there were statistically significant differences between groups
in relation to developing gestational hypertension (P < 0.46), maternal last weight before birth (P < 0.001),
and maternal 6 week postpartum weight (P < 0.001). Women gaining more than 15 pounds were statistically
significantly more likely to have babies that were heavier, develop gestational diabetes, pre-eclampsia, undergo
caesarean section and have labour induced. It is reported that 22 women lost weight who took part in this
study but it is not clear which group they were in. The study did not plan to reduce weight in obese pregnant
women so has been excluded
Vinter 2011
This was a randomised controlled trial from Denmark. 360 obese pregnant women were included; 150 were
randomised to the intervention of dietary counselling from dieticians on 4 occasions and physical activity, and
154 were randomised to the control group which included routine information about the study and access
to a web site on diet and exercise. The primary outcome was to limit gestation weight gain to 5 kilograms in
obese pregnant women, not reduce weight. The results indicated that obstetric outcomes were not significantly
different in both groups. The intervention group had a significantly lower median range of gestational weight
gain compared to the control group. However, as the study did not aim to reduce weight in obese pregnant
women, it has been excluded from this review
Vitolo 2011
This was a randomised controlled trial in Brazil.The participants were healthy pregnant women, n = 315, (n =
156 in the intervention group and n = 159 in the control group). The intervention was dietary advice according
to whether the participant was low weight, normal weight or over weight and the control group had no extra
dietary advice. The aim of the study was to explore weight gain during pregnancy. The results indicated that
weight gain for those who were overweight and in the intervention group was less than those of similar weight
in the control group. It is not clear if the participants were obese, and as maternal weight reduction was not
an outcome, the study has been excluded
Wolff 2008
This was a randomised controlled trial in Denmark. The aim of the study was to explore if restricting gestational
weight gain in obese pregnant women can reduce pregnancy-induced elevations of insulin, leptin and glucose.
50 pregnant obese women took part (n = 23 in the intervention group and n = 27 in the control group). The
intervention was 10 consultations of 1 hour duration with a dietician during the pregnancy. Advice was given
according to Danish dietary recommendations. The control group had usual care and no restrictions on energy
intake and weight gain. The results indicated that the intervention group participants limited their energy
intake, and restricted gestational weight gain to 6.6 kg. The control group gained 13.3 kg. The intervention
was not designed to reduce weight in obese women so has been excluded from the review
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
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APPENDICES
Appendix 1. Methods for updating the review
We will describe for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment
of whether it should produce comparable groups.
We will assess the method as:
low risk of bias (any truly random process, e.g. random number table; computer random number generator);
high risk of bias (any non-random process, e.g. odd or even date of birth; hospital or clinic record number);
unclear risk of bias.
We will describe for each included study the method used to conceal allocation to interventions prior to assignment and will assess
whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.
We will assess the methods as:
low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
high risk of bias (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth);
unclear risk of bias.
(3.1) Blinding of participants and personnel (checking for possible performance bias)
We will describe for each included study the methods used, if any, to blind study participants and personnel from knowledge of which
intervention a participant received. We will consider that studies are at low risk of bias if they were blinded, or if we judge that the lack
of blinding would be unlikely to affect results. We will assess blinding separately for different outcomes or classes of outcomes.
We will assess the methods as:
low, high, or unclear risk of bias for participants;
low, high, or unclear risk of bias for personnel.
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We will describe for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a
participant received. We will assess blinding separately for different outcomes or classes of outcomes.
We will assess methods used to blind outcome assessment as:
low, high, or unclear risk of bias.
(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete
outcome data)
We will describe for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and
exclusions from the analysis. We will state whether attrition and exclusions are reported and the numbers included in the analysis at
each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing
data were balanced across groups or were related to outcomes. Where sufficient information is reported, or could be supplied by the
trial authors, we will re-include missing data in the analyses which we undertake.
We will assess methods as:
low risk of bias (e.g. 20% or less missing outcome data; missing outcome data balanced across groups);
high risk of bias (e.g. greater than 20% missing data; missing data imbalanced across groups; as treated analysis done with
substantial departure of intervention received from that assigned at randomisation);
unclear risk of bias.
(5) Selective reporting (checking for reporting bias)
We will describe for each included study how we will investigate the possibility of selective outcome reporting bias and what we find.
We will assess the methods as:
low risk of bias (where it is clear that all of the studys pre-specified outcomes and all expected outcomes of interest to the review
have been reported);
high risk of bias (where not all the studys pre-specified outcomes have been reported; one or more reported primary outcomes
were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key
outcome that would have been expected to have been reported);
unclear risk of bias.
(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)
We will describe for each included study any important concerns we have about other possible sources of bias.
We will assess whether each study is free of other problems that could put it at risk of bias:
low risk of other bias;
high risk of other bias;
unclear whether there is risk of other bias.
(7) Overall risk of bias
We will make explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Handbook (Higgins
2011). With reference to (1) to (6) above, we will assess the likely magnitude and direction of the bias and whether we consider it
likely to impact on the findings. We will explore the impact of the level of bias through undertaking sensitivity analyses - see Sensitivity
analysis.
Measures of treatment effect
Dichotomous data
For dichotomous data, we will present results as summary risk ratio with 95% confidence intervals.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Continuous data
For continuous data, we will use the mean difference if outcomes are measured in the same way between trials. We will use the
standardised mean difference to combine trials that measure the same outcome, but use different methods. If there is evidence of
skewness, we will report this in the text.
Unit of analysis issues
Cluster-randomised trials
We will include cluster-randomised trials in the analyses along with individually-randomised trials. We will adjust their sample sizes
using the methods described in the Handbook using an estimate of the intracluster correlation co-efficient (ICC) derived from the
trial (if possible), from a similar trial or from a study of a similar population. If we use ICCs from other sources, we will report this
and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster-randomised trials and
individually-randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results
from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice
of randomisation unit is considered to be unlikely.
We will acknowledge heterogeneity in the randomisation unit and perform a sensitivity analysis to investigate the effects of the
randomisation unit.
Cross-over trials
We will not include cross-over trials as these are not an appropriate study design for the interventions in this review.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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CONTRIBUTIONS OF AUTHORS
Christine Furber and Tina Lavender conceived and designed the review.
Christine Furber wrote the protocol.
Tina Lavender, Linda McGowan, Siobhan Quenby, Peter Bower, and Evangelos Kontopantelis contributed significant input to the text
and carefully reviewed drafts of the protocol.
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
The University of Manchester, UK.
External sources
National Institute of Health Research, UK.
NIHR NHS Cochrane Collaboration Programme grant scheme award for NHS-prioritised centrally-managed, pregnancy and
childbirth systematic reviews: CPGS 10/4001/02
INDEX TERMS
Medical Subject Headings (MeSH)
Pregnancy
Outcome; Weight Loss; Obesity [ therapy]; Pregnancy Complications [ therapy]; Prenatal Care [ methods]
Antenatal interventions for reducing weight in obese women for improving pregnancy outcome (Review)
Copyright 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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