Dietary and Lifestyle Interventions in Obese Pregnant Women
NCT ID: NCT02095028
Last Updated: 2014-03-24
Study Results
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Basic Information
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COMPLETED
NA
373 participants
INTERVENTIONAL
2011-04-30
2012-05-31
Brief Summary
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Objective: This study examined whether intensive dietary and lifestyle interventions initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy outcomes in Chinese obese pregnant women.
Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of gestation.The sample size was estimated using GWG reduction as the primary outcome variable. The investigators pilot study (data not published) showed the gestational weight gain was 12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up during pregnancy, the total sample size required was 136 women in intervention group and 68 in control group(standard care group). Participants were randomly assigned to the control or the intervention group. The intervention focused on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian section.
Hypothesis:The intensive dietary and lifestyle intervention performed from the first trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard care group
Standard care group:Participants received one group session in which prenatal general dietary, nutrition guideline, physical activity and recommendation for gestational weight gain introduced by a registered dietitian in 1.5hours.Participants received their regularly scheduled visits without additional dietary and lifestyle follow-up and guidance.
No interventions assigned to this group
Dietary and lifestyle intervention
Intervention group:Based on standard care,intensive dietary and lifestyle intervention was provided. Initiated from the first trimester to delivery,every 2-4 weeks follow-up
Dietary and lifestyle intervention
participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
Interventions
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Dietary and lifestyle intervention
participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
Eligibility Criteria
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Inclusion Criteria
* age ≥18 years, and a singleton pregnancy.
Exclusion Criteria
* gestational weeks ≥ 13
* age \<18 years
* multiple pregnancy
* uterine malformation
* or physical restriction that prevents exercise.
18 Years
45 Years
FEMALE
No
Sponsors
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Ministry of Health, China
OTHER_GOV
Capital Medical University
OTHER
Responsible Party
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Guanghui Li
Associate Professor, MD,PhD
Principal Investigators
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Guanghui Li, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Obstetrics and Gynecology Hospital
Locations
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Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, , China
Countries
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References
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Heslehurst N, Rankin J, Wilkinson JR, Summerbell CD. A nationally representative study of maternal obesity in England, UK: trends in incidence and demographic inequalities in 619 323 births, 1989-2007. Int J Obes (Lond). 2010 Mar;34(3):420-8. doi: 10.1038/ijo.2009.250. Epub 2009 Dec 22.
Stothard KJ, Tennant PW, Bell R, Rankin J. Maternal overweight and obesity and the risk of congenital anomalies: a systematic review and meta-analysis. JAMA. 2009 Feb 11;301(6):636-50. doi: 10.1001/jama.2009.113.
Mission JF, Marshall NE, Caughey AB. Obesity in pregnancy: a big problem and getting bigger. Obstet Gynecol Surv. 2013 May;68(5):389-99. doi: 10.1097/OGX.0b013e31828738ce.
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 May 10;10:47. doi: 10.1186/1741-7015-10-47.
Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.
Guelinckx I, Devlieger R, Mullie P, Vansant G. Effect of lifestyle intervention on dietary habits, physical activity, and gestational weight gain in obese pregnant women: a randomized controlled trial. Am J Clin Nutr. 2010 Feb;91(2):373-80. doi: 10.3945/ajcn.2009.28166. Epub 2009 Dec 2.
Phelan S, Phipps MG, Abrams B, Darroch F, Schaffner A, Wing RR. Randomized trial of a behavioral intervention to prevent excessive gestational weight gain: the Fit for Delivery Study. Am J Clin Nutr. 2011 Apr;93(4):772-9. doi: 10.3945/ajcn.110.005306. Epub 2011 Feb 10.
Kinnunen TI, Pasanen M, Aittasalo M, Fogelholm M, Hilakivi-Clarke L, Weiderpass E, Luoto R. Preventing excessive weight gain during pregnancy - a controlled trial in primary health care. Eur J Clin Nutr. 2007 Jul;61(7):884-91. doi: 10.1038/sj.ejcn.1602602. Epub 2007 Jan 17.
Streuling I, Beyerlein A, von Kries R. Can gestational weight gain be modified by increasing physical activity and diet counseling? A meta-analysis of interventional trials. Am J Clin Nutr. 2010 Oct;92(4):678-87. doi: 10.3945/ajcn.2010.29363. Epub 2010 Jul 28.
Nascimento SL, Surita FG, Parpinelli MA, Siani S, Pinto e Silva JL. The effect of an antenatal physical exercise programme on maternal/perinatal outcomes and quality of life in overweight and obese pregnant women: a randomised clinical trial. BJOG. 2011 Nov;118(12):1455-63. doi: 10.1111/j.1471-0528.2011.03084.x. Epub 2011 Sep 6.
Connor Gorber S, Tremblay M, Moher D, Gorber B. A comparison of direct vs. self-report measures for assessing height, weight and body mass index: a systematic review. Obes Rev. 2007 Jul;8(4):307-26. doi: 10.1111/j.1467-789X.2007.00347.x.
Kiel DW, Dodson EA, Artal R, Boehmer TK, Leet TL. Gestational weight gain and pregnancy outcomes in obese women: how much is enough? Obstet Gynecol. 2007 Oct;110(4):752-8. doi: 10.1097/01.AOG.0000278819.17190.87.
Dodd JM, Crowther CA, Robinson JS. Dietary and lifestyle interventions to limit weight gain during pregnancy for obese or overweight women: a systematic review. Acta Obstet Gynecol Scand. 2008;87(7):702-6. doi: 10.1080/00016340802061111.
Carreno CA, Clifton RG, Hauth JC, Myatt L, Roberts JM, Spong CY, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Sciscione A, Tolosa JE, Saade GR, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Excessive early gestational weight gain and risk of gestational diabetes mellitus in nulliparous women. Obstet Gynecol. 2012 Jun;119(6):1227-33. doi: 10.1097/AOG.0b013e318256cf1a.
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Wolff S, Legarth J, Vangsgaard K, Toubro S, Astrup A. A randomized trial of the effects of dietary counseling on gestational weight gain and glucose metabolism in obese pregnant women. Int J Obes (Lond). 2008 Mar;32(3):495-501. doi: 10.1038/sj.ijo.0803710. Epub 2008 Jan 29.
Asbee SM, Jenkins TR, Butler JR, White J, Elliot M, Rutledge A. Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):305-12. doi: 10.1097/AOG.0b013e318195baef.
Thornton YS, Smarkola C, Kopacz SM, Ishoof SB. Perinatal outcomes in nutritionally monitored obese pregnant women: a randomized clinical trial. J Natl Med Assoc. 2009 Jun;101(6):569-77. doi: 10.1016/s0027-9684(15)30942-1.
Luoto R, Kinnunen TI, Aittasalo M, Kolu P, Raitanen J, Ojala K, Mansikkamaki K, Lamberg S, Vasankari T, Komulainen T, Tulokas S. Primary prevention of gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial. PLoS Med. 2011 May;8(5):e1001036. doi: 10.1371/journal.pmed.1001036. Epub 2011 May 17.
Other Identifiers
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201002013
Identifier Type: OTHER
Identifier Source: secondary_id
2011-2011-02
Identifier Type: -
Identifier Source: org_study_id
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