Abstract
Background
Mothers and their offspring may benefit from lifestyle interventions during pregnancy. We systematically reviewed the literature to map and evaluate the quality of long-term offspring outcomes in follow-up cohorts of randomised controlled trials (RCTs).
Methods
We searched MEDLINE, EMBASE, CINAHL, Database of Abstracts of Reviews of Effects and Cochrane Central (until March 2019) for all RCTs evaluating any lifestyle (diet or exercise) intervention during pregnancy and their follow-up cohorts. Two reviews evaluated the extracted outcomes using two standardised assessment tools, one for quality of reporting (score range 0–6) and another for the variation in outcome selection. We extracted data in duplicate and reported using natural frequencies, medians, ranges, means and standard deviation (SD).
Results
We captured 30 long-term offspring outcomes reported in six articles (four studies). Offspring anthropometric measurements were the most commonly reported outcomes. There was a large variation in the measurement tools used. The mean overall quality score for outcome reporting was 3.33 (SD 1.24), with poor reporting of secondary outcomes and limited justification for the choice of the reported outcomes. Most studies showed selective reporting for both their primary and secondary outcomes.
Conclusion
The quality of reporting for long-term offspring outcomes following lifestyle interventions in pregnancy is varied with evidence of selective outcome reporting. Developing a core outcome set will help to reduce the variations in outcome reporting to optimise future research.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
1. Arabin B, Stupin JH. Overweight and obesity before, during and after pregnancy: part 2. Evidence-based risk factors and interventions. Geburtshilfe Frauenheilkd 2014;74:646–55.10.1055/s-0034-1368462Search in Google Scholar PubMed PubMed Central
2. Rasmussen KM, Yaktine AL. Weight gain during pregnancy: reexamining the guidelines. Washington: The National Academies Press, 2009.Search in Google Scholar
3. NICE. Dietary interventions and physical activity interventions for weight management before, during and after pregnancy (PH27). July, 2010. http://guidance.nice.org.uk/PH27. Accessed 15 Oct 2018.Search in Google Scholar
4. International Weight Management in Pregnancy (I-WIP) Collaborative Group. Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials. Br Med J 2017;358:j3119.10.1136/bmj.j3119Search in Google Scholar PubMed PubMed Central
5. Rogozinska E, Chamillard M, Hitman GA, Khan KS, Thangaratinam S. Nutritional manipulation for the primary prevention of gestational diabetes mellitus: a meta-analysis of randomised studies. PLoS One 2015;10:1–21.10.1371/journal.pone.0115526Search in Google Scholar PubMed PubMed Central
6. Oteng-Ntim E, Varma R, Croker H, Poston L, Doyle P. Lifestyle interventions for overweight and obese pregnant women to improve pregnancy outcome: systematic review and meta-analysis. BMC Med 2012;10:47–62.10.1186/1741-7015-10-47Search in Google Scholar PubMed PubMed Central
7. Khan KS, Kunz R, Kleijnen J, Antes G. Systematic reviews to support evidence-based medicine: how to review and apply findings of healthcare research, 2nd ed. Hodder Arnold: London, 2011.10.1201/b13411Search in Google Scholar
8. Khan KS. The CROWN Initiative: Journal editors invite researchers to develop core outcomes in women’s health. Br J Obstect Gynecol 2014;121:1181–2.10.1111/1471-0528.12929Search in Google Scholar PubMed
9. Liberati A, Altman D, Tetzlaff J, Mulrow C, Gøtzsche P, Ioannidis J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. Br Med J 2009;339:b2700.10.1136/bmj.b2700Search in Google Scholar PubMed PubMed Central
10. Harman NL, Bruce IA, Callery P, Tierney S, Sharif MO, O’Brien K, et al. MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials 2013;14:70.10.1186/1745-6215-14-70Search in Google Scholar PubMed PubMed Central
11. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. Br Med J 2010;340:c365.10.1136/bmj.c365Search in Google Scholar PubMed
12. Dwan K, Gamble C, Kolamunnage-Dona R, Mohammed S, Powell C, Williamson PR. Assessing the potential for outcome reporting bias in a review: a tutorial. Trials 2010;11:52.10.1186/1745-6215-11-52Search in Google Scholar PubMed PubMed Central
13. Luoto RM, Kinnunen TI, Aittasalo M, Ojala K, Mansikkamäki K, Toropainen E, et al. Prevention of gestational diabetes: design of a cluster-randomized controlled trial and one-year follow-up. BMC Pregnancy Childbirth 2010;10:39.10.1186/1471-2393-10-39Search in Google Scholar
14. Althuizen E, van der Wijden CL, van Mechelen W, Seidell JC, van Poppel MN. The effect of a counselling intervention on weight changes during and after pregnancy: a randomised trial. Br J Obstect Gynecol 2013;120:92–9.10.1111/1471-0528.12014Search in Google Scholar
15. Vesco KK, Karanja N, King JC, Gillman MW, Perrin N, McEvoy C, et al. Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale. Contemp Clin Trials 2012;33:777–85.10.1016/j.cct.2012.03.006Search in Google Scholar
16. Rauh K, Kunath J, Rosenfeld E, Kick L, Ulm K, Hauner H. Healthy living in pregnancy: a cluster-randomized controlled trial to prevent excessive gestational weight gain-rationale and design of the GeliS study. BMC Pregnancy Childbirth 2014;14:119.10.1186/1471-2393-14-119Search in Google Scholar
17. Assaf-Balut C, de la Torre NG, Durán A, Fuentes M, Bordiú E, del Valle L, et al. Mediterranean diet with additional extra virgin olive oil and pistachios reduces the incidence of gestational diabetes mellitus (GDM): a randomized controlled trial: The St. Carlos GDM prevention study. PLoS One 2017;12:e0185873.10.1371/journal.pone.0185873Search in Google Scholar
18. Peaceman AM, Kwasny MJ, Gernhofer N, Vincent E, Josefson JL, Van Horn L. 2: MOMFIT: A randomized clinical trial of an intervention to prevent excess gestational weight gain in overweight and obese women. Am J Obstet Gynecol 2017;216:S2–3.10.1016/j.ajog.2016.11.003Search in Google Scholar
19. Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Jørgensen JS. The LiP (Lifestyle in Pregnancy) study: a randomized controlled trial of lifestyle intervention in 360 obese pregnant women. Diabetes Care 2011;34:2502–7.10.2337/dc11-1150Search in Google Scholar
20. Walsh J, Mahony R, Foley M, Mc Auliffe F. A randomised control trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of macrosomia. BMC Pregnancy Childbirth 2010;10:16.10.1186/1471-2393-10-16Search in Google Scholar
21. Rauh K, Gabriel E, Kerschbaum E, Schuster T, von Kries R, Amann-Gassner U, et al. Safety and efficacy of a lifestyle intervention for pregnant women to prevent excessive maternal weight gain: a cluster-randomized controlled trial. BMC Pregnancy Childbirth 2013;13:151.10.1186/1471-2393-13-151Search in Google Scholar
22. Poston L, Bell R, Croker H, Flynn AC, Godfrey KM, Goff L, et al. Effect of a behavioural intervention in obese pregnant women (the UPBEAT study): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol 2015;3:767–77.10.1016/S2213-8587(15)00227-2Search in Google Scholar
23. Vinter CA, Jensen DM, Ovesen P, Beck-Nielsen H, Tanvig M, Lamont RF, et al. Postpartum weight retention and breastfeeding among obese women from the randomized controlled Lifestyle in Pregnancy (LiP) trial. Acta Obstet Gynecol Scand 2014;93:794–801.10.1111/aogs.12429Search in Google Scholar PubMed
24. Tanvig M, Vinter CA, Jørgensen JS, Wehberg S, Ovesen PG, Lamont RF, et al. Anthropometrics and body composition by dual energy X-ray in children of obese women: a follow-up of a randomized controlled trial (the Lifestyle in Pregnancy and Offspring [LiPO] study). PLoS One 2014;9:e89590.10.1371/journal.pone.0089590Search in Google Scholar PubMed PubMed Central
25. Tanvig M, Vinter CA, Jørgensen JS, Wehberg S, Ovesen PG, Beck-Nielsen H, et al. Effects of lifestyle intervention in pregnancy and anthropometrics at birth on offspring metabolic profile at 2.8 years: results from the Lifestyle in Pregnancy and Offspring (LiPO) study. J Clin Endocrinol Metab 2015;100:175–83.10.1210/jc.2014-2675Search in Google Scholar PubMed
26. Horan MK, Donnelly JM, McGowan CA, Gibney ER, McAuliffe FM. The association between maternal nutrition and lifestyle during pregnancy and 2-year-old offspring adiposity: analysis from the ROLO study. J Public Health 2016;24:427–36.10.1007/s10389-016-0740-9Search in Google Scholar PubMed PubMed Central
27. Rauh K, Günther J, Kunath J, Stecher L, Hauner H. Lifestyle intervention to prevent excessive maternal weight gain: mother and infant follow-up at 12 months postpartum. BMC Pregnancy Childbirth 2015;15:265.10.1186/s12884-015-0701-2Search in Google Scholar PubMed PubMed Central
28. Patel N, Hellmuth C, Uhl O, Godfrey K, Briley A, Welsh P, et al. Cord metabolic profiles in obese pregnant women: insights into offspring growth and body composition. J Clin Endocrinol Metab 2018;103:346–55.10.1210/jc.2017-00876Search in Google Scholar PubMed PubMed Central
29. Rogozińska E, Marlin N, Yang F, Dodd JM, Guelfi K, Teede H, et al. Variations in reporting of outcomes in randomized trial son diet and physical activity in pregnancy: a systematic review. J Obstet Gynaecol Res 2017;43:1101–10.10.1111/jog.13338Search in Google Scholar PubMed
30. Al Wattar BH, Placzek A, Troko J, Pirie AM, Khan KS, McCorry D, et al. Variation in the reporting of outcomes among pregnant women with epilepsy: a systematic review. Eur J Obstet Gynecol Reprod Biol 2015;195:193–9.10.1016/j.ejogrb.2015.10.017Search in Google Scholar PubMed
31. Davenport MH, Meah VL, Ruchat SM, Davies GA, Skow RJ, Barrowman N, et al. Impact of prenatal exercise on neonatal and childhood outcomes: a systematic review and meta-analysis. Br J Sports Med 2018;52:1386–96.10.1136/bjsports-2018-099836Search in Google Scholar PubMed
32. Renault KM, Nørgaard K, Nilas L, Carlsen EM, Cortes D, Pryds O, et al. The treatment of obese pregnant women (TOP) study: a randomized controlled trial of the effect of physical activity intervention assessed by pedometer with or without dietary intervention in obese pregnant women. Am J Obstet Gynecol 2014;210:134.e1–9.10.1016/j.ajog.2013.09.029Search in Google Scholar PubMed
33. The University of Liverpool. Core Outcome Measures in Effectiveness Trials. COMET Initiative. http://www.comet-initiative.org/. Accessed 16 Aug 2018.Search in Google Scholar
34. CoRe Outcomes in WomeN’s health (CROWN) Initiative. http://www.crown-initiative.org/. Accessed Sep 2018.Search in Google Scholar
35. Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol 2014;67:745–53.10.1016/j.jclinepi.2013.11.013Search in Google Scholar PubMed
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/jpm-2019-0302).
©2020 Walter de Gruyter GmbH, Berlin/Boston
