Design of FitFor2 study: the effects of an exercise program on insulin sensitivity and plasma glucose levels in pregnant women at high risk for gestational diabetes

Nicolette Oostdam, Mireille N M van Poppel, Elisabeth M W Eekhoff, Maurice G A J Wouters, Willem van Mechelen, Nicolette Oostdam, Mireille N M van Poppel, Elisabeth M W Eekhoff, Maurice G A J Wouters, Willem van Mechelen

Abstract

Background: Pregnancy is a period in the life of women that is often associated with decreased daily physical activity and/or exercise. However, maintaining adequate levels of daily physical activity during pregnancy is important for mother and child. Studies suggest that moderate daily physical activity and exercise during pregnancy are associated with reductions in the risk of gestational diabetes mellitus (GDM). However, at present, physical activity is not routinely advised to pregnant women at risk for gestational diabetes in the Netherlands. In FitFor2-study we aim to assess whether an exercise program can improve insulin sensitivity and fasting plasma glucose levels of women at high risk for gestational diabetes, assuming that this will lower their risk of gestational diabetes.

Methods: The FitFor2-study is a randomised controlled trial. Women who visit one of the participating hospitals or midwifery practices and who are at risk for gestational diabetes are eligible to participate. After baseline measurement they are randomly allocated to in the intervention or control group. The intervention group receives an exercise program twice a week in addition to usual care. The exercise program consist of aerobic and strength exercises and takes place under close supervision of a physiotherapist. Data are collected at 15, 24 and 32 weeks of pregnancy and 12 weeks after delivery. Primary maternal outcome measures are fasting plasma glucose and relative increase in insulin resistance. Primary neonatal outcome is birth weight. Secondary outcome measures are: maternal serum triglycerides, HDL, cholesterol, HbA1c, maternal weight gain during pregnancy, maternal physical activity level, foetal growth.

Discussion: If the FitFor2 intervention program proves to be effective, obstetricians and midwives should refer women at risk for GDM to a special exercise program. Exercise programs for pregnant women under supervision of an experienced trainer are already available in the Netherlands, and these programs could be adjusted easily for this target group. Furthermore, the costs of these programs should be refunded by including them in the basic health care cost reimbursement schemes.

Trial registration: NTR1139.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Oddvar Holten diagram.
Figure 3
Figure 3
Formula. A: lifted weight; B: percentage of intensity.

References

    1. Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007;39:1423–1434. doi: 10.1249/mss.0b013e3180616b27.
    1. US Surgeon General . Physical activity and health; a report of the surgeon general. Altanta: US Department of Health and Human Services, CDC, National Center for Disease Control and Prevention, USA; 1996.
    1. Fell DB, Joseph KS, Armson BA, Dodds L. The Impact of Pregnancy on Physical Activity Level. Matern Child Health J. 2008
    1. Ning Y, Williams MA, Dempsey JC, Sorensen TK, Frederick IO, Luthy DA. Correlates of recreational physical activity in early pregnancy. J Matern Fetal Neonatal Med. 2003;13:385–393. doi: 10.1080/713605926.
    1. Buchanan TA, Xiang A, Kjos SL, Watanabe R. What is gestational diabetes? Diabetes Care. 2007;30:S105–S111. doi: 10.2337/dc07-s201.
    1. Dempsey JC, Butler CL, Sorensen TK, Lee IM, Thompson ML, Miller RS, Frederick IO, Williams MA. A case-control study of maternal recreational physical activity and risk of gestational diabetes mellitus. Diabetes Res Clin Pract. 2004;66:203–215. doi: 10.1016/j.diabres.2004.03.010.
    1. Wang TW, Apgar BS. Exercise during pregnancy. Am Fam Physician. 1998;57:1846–52.
    1. Brown W. The benefits of physical activity during pregnancy. J Sci Med Sport. 2002;5:37–45. doi: 10.1016/S1440-2440(02)80296-1.
    1. Clapp JF., III Exercise during pregnancy. A clinical update. Clin Sports Med. 2000;19:273–286. doi: 10.1016/S0278-5919(05)70203-9.
    1. Penney DS. The effect of vigorous exercise during pregnancy. J Midwifery Womens Health. 2008;53:155–159. doi: 10.1016/j.jmwh.2007.12.003.
    1. Clapp JF, III, Rokey R, Treadway JL, Carpenter MW, Artal RM, Warrnes C. Exercise in pregnancy. Med Sci Sports Exerc. 1992;24:S294–S300.
    1. Clapp JF, III, Capeless EL. The changing glycemic response to exercise during pregnancy. Am J Obstet Gynecol. 1991;165:1678–1683.
    1. Jovanovic-Peterson L, Durak EP, Peterson CM. Randomized trial of diet versus diet plus cardiovascular conditioning on glucose levels in gestational diabetes. Am J Obstet Gynecol. 1989;161:415–419.
    1. Avery MD, Walker AJ. Acute effect of exercise on blood glucose and insulin levels in women with gestational diabetes. J Matern Fetal Med. 2001;10:52–58. doi: 10.1080/714904296.
    1. Garcia-Patterson A, Martin E, Ubeda J, Maria MA, de Leiva A, Corcoy R. Evaluation of light exercise in the treatment of gestational diabetes. Diabetes Care. 2001;24:2006–2007. doi: 10.2337/diacare.24.11.2006.
    1. Brankston GN, Mitchell BF, Ryan EA, Okun NB. Resistance exercise decreases the need for insulin in overweight women with gestational diabetes mellitus. Am J Obstet Gynecol. 2004;190:188–193. doi: 10.1016/S0002-9378(03)00951-7.
    1. Dempsey JC, Butler CL, Williams MA. No need for a pregnant pause: physical activity may reduce the occurrence of gestational diabetes mellitus and preeclampsia. Exerc Sport Sci Rev. 2005;33:141–149. doi: 10.1097/00003677-200507000-00007.
    1. Oken E, Ning Y, Rifas-Shiman SL, Radesky JS, Rich-Edwards JW, Gillman MW. Associations of physical activity and inactivity before and during pregnancy with glucose tolerance. Obstet Gynecol. 2006;108:1200–1207.
    1. Gavard JA, Artal R. Effect of exercise on pregnancy outcome. Clin Obstet Gynecol. 2008;51:467–480. doi: 10.1097/GRF.0b013e31816feb1d.
    1. Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003;26:3230–3236. doi: 10.2337/diacare.26.12.3230.
    1. Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998;21:B161–B167.
    1. Metzger BE, Buchanan TA, Coustan DR, de Leiva A, Dunger DB, Hadden DR, Hod M, Kitzmiller JL, Kjos SL, Oats JN, Pettitt DJ, Sacks DA, Zoupas C. Summary and recommendations of the Fifth International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. 2007;30:S251–S260. doi: 10.2337/dc07-s225.
    1. Wolfe LA, Davies GA. Canadian guidelines for exercise in pregnancy. Clin Obstet Gynecol. 2003;46:488–495. doi: 10.1097/00003081-200306000-00027.
    1. Hertling D, Kessler RM. Management of Common Musculoskeletal Disorders. Third. Philadelphia: Lippincot; 1996.
    1. American College of Sports Medicine . ACMS's guidelines for exercise testing and prescription. 7. Baltimore: Lippincott Williams & Wilkins; 2005.
    1. Artal R, O'Toole M. Guidelines of the American College of Obstetricians and Gynecologists for exercise during pregnancy and the postpartum period. Br J Sports Med. 2003;37:6–12. doi: 10.1136/bjsm.37.1.6.
    1. Davies GA, Wolfe LA, Mottola MF, MacKinnon C, Arsenault MY, Bartellas E, Cargill Y, Gleason T, Iglesias S, Klein M, Martel MJ, Roggensack A, Wilson K, Gardiner P, Graham T, Haennel R, Hughson R, MacDougall D, McDermott J, Ross R, Tiidus P, Trudeau F. Exercise in pregnancy and the postpartum period. J Obstet Gynaecol Can. 2003;25:516–529.
    1. Wolfe LA, Weissgerber TL. Clinical physiology of exercise in pregnancy: a literature review. J Obstet Gynaecol Can. 2003;25:473–483.
    1. Canadian Society for Exercise Physiology (CSEP) Physical Activity Readiness Medical Examination for Pregnancy (PARmed-X for Pregnancy) Canadian Society for Exercise Physiology (CSEP); 2002. pp. 1–4.
    1. Clapp JF., III A clinical approach to exercise during pregnancy. Clin Sports Med. 1994;13:443–458.
    1. Slootmaker SM, Chin APM, Schuit AJ, Seidell JC, van Mechelen W. Promoting physical activity using an activity monitor and a tailored web-based advice: design of a randomized controlled trial [ISRCTN93896459] BMC Public Health. 2005;5:134. doi: 10.1186/1471-2458-5-134.
    1. Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:53–72. doi: 10.1016/0168-8510(96)00822-6.
    1. Group EQ EuroQol – a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Oostenbrink JB, Koopmanschap MA, Rutten FF. Standardisation of costs: the Dutch Manual for Costing in economic evaluations. Pharmacoeconomics. 2002;20:443–454. doi: 10.2165/00019053-200220070-00002.
    1. Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999;22:1462–1470. doi: 10.2337/diacare.22.9.1462.
    1. Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28:412–419. doi: 10.1007/BF00280883.
    1. Chaudhary MA, Stearns SC. Estimating confidence intervals for cost-effectiveness ratios: an example from a randomized trial. Stat Med. 1996;15:1447–1458. doi: 10.1002/(SICI)1097-0258(19960715)15:13<1447::AID-SIM267>;2-V.
    1. Briggs A, Fenn P. Confidence intervals or surfaces? Uncertainty on the cost-effectiveness plane. Health Econ. 1998;7:723–740. doi: 10.1002/(SICI)1099-1050(199812)7:8<723::AID-HEC392>;2-O.
    1. Herbst MA. Treatment of suspected fetal macrosomia: a cost-effectiveness analysis. Am J Obstet Gynecol. 2005;193:1035–1039. doi: 10.1016/j.ajog.2005.06.030.
    1. Culligan PJ, Myers JA, Goldberg RP, Blackwell L, Gohmann SF, Abell TD. Elective cesarean section to prevent anal incontinence and brachial plexus injuries associated with macrosomia – a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16:19–28. doi: 10.1007/s00192-004-1203-3.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever