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Obstetrics
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

Presented, in part, at the first Nordic Congress on Obesity in Gynecology and Obstetrics, Billund, Denmark, Oct. 22-24, 2012, and the 44th annual meeting of the Diabetes in Pregnancy Study Group, Lille, France, Oct. 18-21, 2012.
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Objective

The objective of the study was to assess physical activity intervention assessed by a pedometer with or without dietary intervention on gestational weight gain (GWG) in obese pregnant women by comparing with a control group.

Study Design

This study was a randomized controlled trial of 425 obese pregnant women comparing 3 groups: (1) PA plus D, physical activity and dietary intervention (n = 142); (2) PA, physical activity intervention (n = 142); and (3) C, a control group receiving standard care (n = 141). All participants routinely in gestational weeks 11-14 had an initial dietary counseling session and were advised to limit GWG to less than 5 kg. Physical activity intervention included encouragement to increase physical activity, aiming at a daily step count of 11,000, monitored by pedometer assessment on 7 consecutive days every 4 weeks. Dietary intervention included follow-up on a hypocaloric Mediterranean-style diet. Instruction was given by a dietician every 2 weeks. The primary outcome measure was GWG, and the secondary outcome measures were complications of pregnancy and delivery and neonatal outcome.

Results

The study was completed by 389 patients (92%). Median values of GWG (ranges) were lower in each of the intervention groups (PA plus D, 8.6 [–9.6 to 34.1] kg, and group PA, 9.4 [–3.4 to 28.2] kg) compared with the control group (10.9 [–4.4 to 28.7] kg [PA+D vs C]; P = .01; PA vs C; P = .042). No significant difference was found between the 2 intervention groups. In a multivariate analysis, physical activity intervention decreased GWG by a mean of 1.38 kg (P = .040). The Institute of Medicine's recommendations for GWG were more frequently followed in the intervention groups.

Conclusion

Physical activity intervention assessed by pedometer with or without dietary follow-up reduced GWG compared with controls in obese pregnant women.

Section snippets

Materials and Methods

A prospective, randomized controlled trial was conducted from March 2009 to March 2012 at Hvidovre Hospital, University of Copenhagen, with 7000 deliveries annually. All pregnant women with a prepregnancy BMI of 30 kg/m2 or greater were identified when booking for the initial ultrasound nuchal translucency scan. They were offered one consultation with a dietician as soon as possible after the ultrasound examination in gestational weeks 11-14, which is routine practice in the department.

The

Results

In the inclusion period, 758 pregnant women were considered eligible for inclusion, and 425 (56%) participated. In total 389 women completed the study (Figure 1).

Participants still included at delivery did not differ with respect to dropout rate or to sociodemographic characteristics within the 3 groups (Table 1). The women who dropped out were more often nonwhite. Information on weight gain missed in 13 women because they delivered preterm. One woman allocated to group PA delivered in

Comment

In the present study, physical activity intervention with a pedometer resulted in a GWG, which was 1.4 kg lower than that of women who did not have intervention by using a pedometer. Follow-up on counseling by a dietitian in combination with physical activity led to a modest reduction in GWG, but the additional effect on GWG was not significant. Birthweight and the risk of macrosomia increased with GWG, but GWG less than 5 kg in obese pregnant women did not result in SGA infants.

Acknowledgments

K.M.R., K.N., L.N., and N.J.S. planned the study and designed the research. K.M.R. coordinated the day-to-day running of the study and conducted the research. K.M.R. and K.N. analyzed the data. K.M.R., K.N., O.P., and E.M.C. performed the statistical analysis. K.M.R. wrote the draft, and all authors contributed to the writing of the manuscript and approved the final manuscript. And N.J.S. and K.M.R. had the primary responsibility for the final content.

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    This study was supported by the Sygekassernes Helsefond and Broedrene Hartmann Fonden.

    The authors report no conflict of interest.

    Cite this article as: Renault KM, Nørgaard K, Nilas L, 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.

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