Dietary and Lifestyle Interventions in Obese Pregnant Women

Obesity Clinical Trial

Official title:

Effects of Dietary and Lifestyle Interventions in Obese Pregnant Women From the First Trimester on Gestational Weight Gain and Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095028
• Other study ID #: 2011-2011-02
• Secondary ID: 201002013
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 21, 2014
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• gestational age between 6 and 12 weeks of gestation, pre-pregnancy=28 (kg/m2)

• age =18 years, and a singleton pregnancy.

Exclusion Criteria:

• patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder

• gestational weeks = 13

• age <18 years

• multiple pregnancy

• uterine malformation

• or physical restriction that prevents exercise.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lifestyle
• Obesity
• Pregnancy Related
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (20)

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.0b013e — View Citation

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 Devel — View Citation

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. Review. — View Citation

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. Review. — View Citation

Gibson KS, Waters TP, Catalano PM. Maternal weight gain in women who develop gestational diabetes mellitus. Obstet Gynecol. 2012 Mar;119(3):560-5. doi: 10.1097/AOG.0b013e31824758e0. — View Citation

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. — View Citation

Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. Review. — View Citation

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. Erratum in: Int J Obes (Lond). 2010 Aug;34(8):1353. — View Citation

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. — View Citation

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. Epub 2007 Jan 17. — View Citation

Luoto R, Kinnunen TI, Aittasalo M, Kolu P, Raitanen J, Ojala K, Mansikkamäki 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- — View Citation

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. Review. — View Citation

Nascimento SL, Surita FG, Parpinelli MÂ, 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain		From enrollment to delivery (28-34 weeks of gestation)	No
Secondary	The incidence of gestational diabetes mellitus		From enrollment to delivery (28-34 weeks of gestation)	No
Secondary	The incidence of hypertensive disorders during pregnancy		From enrollment to delivery (28-34 weeks of gestation)	No
Secondary	The incidence of large-for-gestational-age infants		From enrollment to delivery(28-34 weeks of gestation)	No
Secondary	The incidence of macrosomia infants		From enrollment to delivery (28-34 weeks of gestation)	No
Secondary	The rate of caesarian section		From enrollment to delivery(28-34 weeks of gestation)	No