Abstract

Our objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM. We conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ≥ 25 kg/m(2), glucose intolerance or newborn's macrosomia (≥ 4,500 g) in any earlier pregnancy, family history of diabetes, age ≥ 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p = 0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group. The intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM. Current Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary.

Highlights

  • Gestational diabetes mellitus (GDM) is defined as a type of diabetes first diagnosed during pregnancy [1]

  • The intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM

  • In our own pilot study, intensive lifestyle counseling produced favorable changes both in diet and physical activity [15,16]. The aim of this cluster-randomized trial was to examine whether individual intensified counseling on physical activity, diet, and weight gain integrated into routine maternity care visits could prevent the development of GDM and newborns’ high birthweight adjusted for gestational age

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Summary

Introduction

Gestational diabetes mellitus (GDM) is defined as a type of diabetes first diagnosed during pregnancy [1]. In our own pilot study, intensive lifestyle counseling produced favorable changes both in diet and physical activity [15,16] The aim of this cluster-randomized trial was to examine whether individual intensified counseling on physical activity, diet, and weight gain integrated into routine maternity care visits could prevent the development of GDM and newborns’ high birthweight adjusted for gestational age. Risk factors for GDM, which occurs in 2%–14% of pregnant women, include a high body-mass index (a measure of body fat), excessive weight gain or low physical activity during pregnancy, high dietary intake of polyunsaturated fats, glucose intolerance (an indicator of diabetes) or the birth of a large baby in a previous pregnancy, and a family history of diabetes. GDM, which can often be controlled by diet and exercise, usually disappears after pregnancy but increases a woman’s subsequent risk of developing diabetes

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