Primary prevention of gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial

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 wer...

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Published in:	PLoS medicine Vol. 8; no. 5; p. e1001036
Main Authors:	Luoto, Riitta, Kinnunen, Tarja I, Aittasalo, Minna, Kolu, Päivi, Raitanen, Jani, Ojala, Katriina, Mansikkamäki, Kirsi, Lamberg, Satu, Vasankari, Tommi, Komulainen, Tanja, Tulokas, Sirkku
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 01-05-2011 Public Library of Science (PLoS)
Subjects:	Adult Behavior - physiology Birth weight Birth Weight - physiology Body mass index Diabetes Diabetes in pregnancy Diabetes, Gestational - prevention & control Diagnosis Diet Female Finland Gestational Age Glucose Tolerance Test Health aspects Health Education Humans Infant, Newborn Insulin - metabolism Life Style Medicine Motor Activity Patient Compliance Pregnancy Prevention Primary Prevention Risk factors Social and Behavioral Sciences Studies Treatment Outcome Womens health Finland Diabetes, Gestational Glucose Tolerance Test Life Style Primary Prevention Humans Treatment Outcome Motor Activity Gestational Age Insulin Pregnancy Birth Weight Diet Finland Adult Female Behavior Patient Compliance Health Education Infant, Newborn
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Summary:	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.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 Conceived and designed the experiments: RL TIK MA KO. Performed the experiments: KM KO TV. Analyzed the data: JR RL PK TK. Contributed reagents/materials/analysis tools: TV JR PK. Wrote the paper: RL PK TIK MA TV ST. ICMJE criteria for authorship: RL TIK MA KO PK JR SL TV KM TK ST. Results and conclusions: RL TIK MA KO PK JR SL TV KM TK ST. Enrolled patients: TIK MA RL. First draft: PK RL. Planning the counseling and preparing related material, training the nurses for counseling: TIK MA. Design of the thematic meetings on physical activity and material: MA. Group exercise design: KO.
ISSN:	1549-1676 1549-1277 1549-1676
DOI:	10.1371/journal.pmed.1001036