In a Perspective, Jane Norman and Rebecca Reynolds discuss two randomized controlled trials aimed at testing behavioral interventions for women at risk of gestational diabetes

A Berrington de Gonzalez

B Muktabhant

HC Gooding

Jane E. Norman

K Gamaes

KK Lee

M Reiner

Rebecca M. Reynolds

RM Reynolds

S O'Reilly

SB Koivusalo

TT Moholdt

VR Aroda

PubMed

Jane E Norman

Rebecca M Reynolds

Directory of Open Access Journals

PLoS Medicine

Prescribing Exercise and Lifestyle Training for High Risk Women in Pregnancy and Early Post-partum-Is It Worth It?

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     Edinburgh Research Explorer                                      Prescribing exercise and lifestyle training for high risk women inpregnancy and early post-partum—is it worth it?Citation for published version:Norman, J & Reynolds, R 2016, 'Prescribing exercise and lifestyle training for high risk women in pregnancyand early post-partum—is it worth it?' PLoS Medicine, vol. 13, no. 7, e1002093. DOI:10.1371/journal.pmed.1002093Digital Object Identifier (DOI):10.1371/journal.pmed.1002093Link:Link to publication record in Edinburgh Research ExplorerDocument Version:Publisher's PDF, also known as Version of recordPublished In:PLoS MedicineGeneral rightsCopyright for the publications made accessible via the Edinburgh Research Explorer is retained by the author(s)and / or other copyright owners and it is a condition of accessing these publications that users recognise andabide by the legal requirements associated with these rights.Take down policyThe University of Edinburgh has made every reasonable effort to ensure that Edinburgh Research Explorercontent complies with UK legislation. If you believe that the public display of this file breaches copyright pleasecontact openaccess@ed.ac.uk providing details, and we will remove access to the work immediately andinvestigate your claim.Download date: 05. Apr. 2019PERSPECTIVEPrescribing Exercise and Lifestyle Training forHigh Risk Women in Pregnancy and EarlyPost-partum—Is It Worth It?Jane E. Norman1*, Rebecca M. Reynolds1,21 Tommy’s Centre for Maternal and Fetal Health, MRC Centre for Reproductive Health, University ofEdinburgh, Edinburgh, United Kingdom, 2 British Heart Foundation Centre for Cardiovascular Research,University of Edinburgh, Edinburgh, United Kingdom* Jane.Norman@ed.ac.ukThe positive effects of exercise on health are supported by systematic reviews of longitudinalstudies and are widely accepted by clinicians [1]. In pregnancy, current advice from the UnitedKingdom’s National Health Service (NHS) Choices and National Institute for Health and CareExcellence, as well as the American College of Obstetricians and Gynecologists (ACOG), isthat exercise is more likely to be beneficial than harmful, with ACOG advising that “an exerciseprogramme [with] a goal of moderate intensity exercise for at least 20–30 minutes per dayshould be developed with the patient” [2].The research paper by Trine Moholdt and colleagues in PLOS Medicine describes a random-ized trial on the effects of supervised exercise training in obese pregnant women [3]. Womenin the exercise group were offered exercise sessions supervised by a physical therapist at a hos-pital three times weekly from baseline (12–18 weeks) until delivery. The sessions lasted 60 min-utes and included 35 minutes of walking/jogging with additional resistance training. Womenwere also advised to follow 50 minutes of a home exercise program at least once weekly. Thecontrol group was offered routine care, which included “information about healthy eating anda healthy lifestyle.”Exercise training had no effect on the proportion of women reporting being physicallyactive each day in late pregnancy, with rates being just over 60% in both groups. Additionally,the estimated energy expenditure during each session was low (around 400 kcal/session), andonly 50% of participants attended the equivalent of 50% of the sessions or more. However,more women in the exercise intervention group reported exercise training in late pregnancy(77% versus 23%).There was no effect of the intervention on the preplanned primary outcome of mean weightgain in the two groups: 10.5 kg (95% CI 8.9–12.0) for women in the exercise group and 9.2 kg(6.8–11.6) for those in the control group. Nor did the intervention reduce the proportion ofwomen with weight gain above Institute of Medicine recommendations (5–9 kg for womenwith a body mass index [BMI] 30 kg/m2). Amongst the secondary outcomes, a lower rate ofgestational diabetes mellitus (GDM) was reported in the exercise group: this apparent differ-ence reached statistical significance for GDM diagnosed by WHO criteria (6.1% versus 27.3%)but not by the International Association of Diabetes in Pregnancy Study Groups’ criteria.These findings chime with a reduced risk of GDM reported for lifestyle interventions in high-risk women with obesity or a previous history of GDM [4].PLOSMedicine | DOI:10.1371/journal.pmed.1002093 July 26, 2016 1 / 3a11111OPEN ACCESSCitation: Norman JE, Reynolds RM (2016)Prescribing Exercise and Lifestyle Training for HighRisk Women in Pregnancy and Early Post-partum—Is It Worth It? PLoS Med 13(7): e1002093.doi:10.1371/journal.pmed.1002093Published: July 26, 2016Copyright: © 2016 Norman, Reynolds. This is anopen access article distributed under the terms of theCreative Commons Attribution License, which permitsunrestricted use, distribution, and reproduction in anymedium, provided the original author and source arecredited.Funding: RMR and JEN are funded by the charityTommy's. The funders had no role in manuscriptpreparation or decision to publish.Competing Interests: JEN has had grant fundingfrom the UK government within the last three years toevaluate the effect of pharmacological agents inpreventing adverse outcomes in obese pregnantwomen.Abbreviations: ACOG, American College ofObstetricians and Gynecologists; BMI, body massindex; GDM, gestational diabetes mellitus; MAGDA,Mothers after Gestational Diabetes in Australia; NHS,National Health ServiceProvenance: Commissioned; not externally peer-reviewedThe limitations of Moholdt and colleagues’ trial are the lower than planned sample size (91rather than 150 women) and the inclusion of a small number of women (<10% overall) whowere overweight rather than obese. Nevertheless, these data complement those from aCochrane systematic review of diet or exercise interventions (or both) in pregnancy, whichdemonstrated a small but significant reduction in the risk of excessive weight gain (relative risk0.80 [95% CI 0.73–0.87]) but found no effect on mean weight gain in the majority of studies[5].What are the clinical implications of Moholdt and colleagues’ study? It is tempting to benihilistic and to point out that not only did the intervention fail to achieve its stated aim ofreducing mean weight gain but that it is likely to have been prohibitively expensive: provisionof three supervised exercise sessions per week for up to 30 weeks is a major financial undertak-ing. A cost-effectiveness analysis was not performed as part of this study but is unlikely toshow benefit: during the time horizon of the study, even the reduction in GDM is unlikely tooffset the costs of the intervention.So should we stop recommending exercise and/or stop testing exercise interventions inobese pregnant women? The answer might be not that the intervention of exercise (supervisedor otherwise) is ineffective but that inappropriate outcomes are being used to assess utility inpregnancy.For the baby, maternal exercise in pregnancy, with or without a reduction in maternalGDM, might minimize the adverse programming effects of maternal obesity on long-termhealth of the offspring. We have shown that maternal obesity was associated with a 35%increased risk of premature all-cause mortality on offspring by the age of 50 years—even amodest reduction in this risk would have major health and economic benefits for society [6].For the mother, exercise may not reduce mean weight gain in the index pregnancy, but ifthe lifestyle change is maintained, it might mean that she enters the next pregnancy with alower BMI. Additionally, an exercise intervention may have benefits beyond the woman’schildbearing years: a modest fall in bodyweight will reduce the lifelong risk of cardiovasculardisease [7,8].In a separate research study also published in PLOS Medicine (the Mothers after GestationalDiabetes in Australia [MAGDA] trial), Sharleen O'Reilly and colleagues focused on this lifelongrisk to the mother and evaluated a postnatal lifestyle intervention program in women diag-nosed with GDM during pregnancy [9]. Five hundred and seventy-three women wererecruited, with half randomized to the intervention and the other half to usual care. The inter-vention (diet and exercise advice) was delivered in a group exercise (five in total), together withone individual session and two phone sessions, all over a period of 3 months. The majority ofthe participants (66%) were overweight or obese.As in the study by Moholdt and colleagues, engagement by participants was suboptimal inO’Reilly and colleagues’ trial, with only 53% attending one or more sessions. According to thetrial’s coprimary endpoints, the intervention had no significant effect on fasting blood glucose,although a small but significant difference in weight gain was observed over a 12-month period(between-group difference of −0.95 kg, 95% CI −1.87 to −0.04), with the lower weight gainrecorded in the intervention group. As the authors mention, such an intense lifestyle interven-tion may not be cost-effective compared with annual screening for diabetes with interventionin those with impaired glucose tolerance. Additionally, both of these studies highlight the needto engage patients in study design in order to optimize adherence to lifestyle interventions.We note that Moholdt and colleagues plan to follow-up the mothers and babies recruited totheir study, to determine longer-term effects [10]. We would urge them and other investigatorsconducting similar studies, including O’Reilly and colleagues, to do so. Given the major lifelongadverse effects of maternal obesity for both the mother and the baby, effective therapeuticPLOSMedicine | DOI:10.1371/journal.pmed.1002093 July 26, 2016 2 / 3interventions are desperately needed [11]. Guidelines promoting exercise in pregnancy arelikely to do more good than harm, although they are not strongly supported by current evi-dence. Metformin has been shown to be effective in reducing the risk of future diabetes inwomen with a history of GDM, but lifestyle interventions are more effective in obese womenwithout a history of GDM [12]. Hence, lifestyle interventions offer the best promise for preven-tion and should not be abandoned because of limited effectiveness or lack of effectiveness asjudged by short-term surrogate outcomes.Author ContributionsWrote the first draft of the manuscript: JEN. Contributed to the writing of the manuscript: JENRMR. Agree with the manuscript’s results and conclusions: JEN RMR. Both authors have read,and confirm that they meet, ICMJE criteria for authorship.References1. Reiner M, Niermann C, Jekauc D, Woll A. Long-term health benefits of physical activity—a systematicreview of longitudinal studies. BMC Public Health. 2013; 13:813. doi: 10.1186/1471-2458-13-813PMID: 24010994; PubMed Central PMCID: PMCPMC3847225.2. ACOGCommittee Opinion No. 650: Physical Activity and Exercise During Pregnancy and the Postpar-tum Period. Obstet Gynecol. 2015; 126(6):e135–142. doi: 10.1097/AOG.0000000000001214 PMID:26595585.3. Gamaes K, Morkved S, Salvesen O, Moholdt T. Exercise Training andWeight Gain in Obese PregnantWomen: A Randomised Controlled Trial (ETIP Trial). PLoS Med. 2016; 13: e1002079. doi: 10.1371/journal.pmed.10020794. Koivusalo SB, Rono K, Klemetti MM, Roine RP, Lindstrom J, Erkkola M, et al. Gestational DiabetesMellitus Can Be Prevented by Lifestyle Intervention: The Finnish Gestational Diabetes PreventionStudy (RADIEL): A Randomized Controlled Trial. Diabetes Care. 2016; 39(1):24–30. doi: 10.2337/dc15-0511 PMID: 26223239.5. Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise, or both, for preventingexcessive weight gain in pregnancy. Cochrane Database Syst Rev (Online). 2015;(6: ):CD007145. doi:10.1002/14651858.CD007145.pub3 PMID: 26068707.6. Reynolds RM, Allan KM, Raja EA, Bhattacharya S, McNeill G, Hannaford PC, et al. Maternal obesityduring pregnancy and premature mortality from cardiovascular event in adult offspring: follow-up of 1323 275 person years. BMJ. 2013; 347:f4539. doi: 10.1136/bmj.f4539 PMID: 23943697; PubMed Cen-tral PMCID: PMC3805484.7. Gooding HC, Shay CM, Ning H, Gillman MW, Chiuve SE, Reis JP, et al. Optimal Lifestyle Componentsin Young Adulthood Are Associated With Maintaining the Ideal Cardiovascular Health Profile Into Mid-dle Age. J Am Heart Assoc. 2015; 4(11): pii: e002048. doi: 10.1161/JAHA.115.002048 PMID:26514160; PubMed Central PMCID: PMCPMC4845225.8. Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, et al. Body-massindex and mortality among 1.46 million white adults. N Engl J Med. 2010; 363(23):2211–2219. doi: 10.1056/NEJMoa1000367 PMID: 21121834; PubMed Central PMCID: PMCPMC3066051.9. O'Reilly S, Dunbar J, Versace V, Janus E, Best JD, Carter R, et al. Mothers After Gestational Diabetesin Australia (MAGDA): A Randomized, Controlled Trial of a Postnatal Prevention Program. PLoSMed.2016; 13: e1002092. doi: 10.1371/journal.pmed.100209210. Moholdt TT, Salvesen K, Ingul CB, Vik T, Oken E, Morkved S. Exercise Training in Pregnancy forobese women (ETIP): study protocol for a randomised controlled trial. Trials. 2011; 12:154. doi: 10.1186/1745-6215-12-154 PMID: 21682869; PubMed Central PMCID: PMCPMC3148988.11. Lee KK, Raja EA, Lee AJ, Bhattacharya S, Bhattacharya S, Norman JE, et al. Maternal Obesity DuringPregnancy AssociatesWith Premature Mortality and Major Cardiovascular Events in Later Life. Hyper-tension. 2015; 66(5):938–944. doi: 10.1161/HYPERTENSIONAHA.115.05920 PMID: 26370890.12. Aroda VR, Christophi CA, Edelstein SL, Zhang P, HermanWH, Barrett-Connor E, et al. The Effect ofLifestyle Intervention and Metformin on Preventing or Delaying Diabetes AmongWomenWith andWithout Gestational Diabetes: The Diabetes Prevention ProgramOutcomes Study 10-Year Follow-Up.J Clin Endocrinol Metab. 2015:jc20143761. doi: 10.1210/jc.2014-3761 PMID: 25706240.PLOSMedicine | DOI:10.1371/journal.pmed.1002093 July 26, 2016 3 / 3

In a Perspective, Jane Norman and Rebecca Reynolds discuss two randomized controlled trials aimed at testing behavioral interventions for women at risk of gestational diabetes.</p

Norman, Jane E

Reynolds, Rebecca M

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Prescribing Exercise and Lifestyle Training for High Risk Women in Pregnancy and Early Post-partum—Is It Worth It?

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Prescribing exercise and lifestyle training for high risk women in pregnancy and early post-partum—is it worth it?

Prescribing exercise and lifestyle training for high risk women in pregnancy and early post-partum—is it worth it?

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