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Open Access Study protocol

Prevention of gestational diabetes through lifestyle intervention: study design and methods of a Finnish randomized controlled multicenter trial (RADIEL)

Kristiina Rönö12*, Beata Stach-Lempinen3, Miira M Klemetti13, Risto J Kaaja45, Maritta Pöyhönen-Alho2, Johan G Eriksson6789, Saila B Koivusalo2 and On behalf of RADIEL group

Author Affiliations

1 Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland

2 Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Haartmaninkatu 2, P.O. Box 140, 00029 Helsinki, Finland

3 Department of Obstetrics and Gynecology, South-Karelia Central Hospital, Lappeenranta, Finland

4 Satakunta Central Hospital, Pori, Finland

5 University of Turku, Turku, Finland

6 Department of General Practice and Primary Health Care, University of Helsinki, Helsinki, Finland

7 Unit of General Practice, Helsinki University Central Hospital, Helsinki, Finland

8 Folkhälsan Research Centre, Helsinki, Helsingfors Universitet, Helsinki, Finland

9 Department of Chronic Disease Prevention, National Institute for Health and Welfare, Helsinki, Finland

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BMC Pregnancy and Childbirth 2014, 14:70  doi:10.1186/1471-2393-14-70

Published: 14 February 2014

Abstract

Background

Maternal overweight, obesity and consequently the incidence of gestational diabetes are increasing rapidly worldwide. The objective of the study was to assess the efficacy and cost-effectiveness of a combined diet and physical activity intervention implemented before, during and after pregnancy in a primary health care setting for preventing gestational diabetes, later type 2 diabetes and other metabolic consequences.

Methods

RADIEL is a randomized controlled multi-center intervention trial in women at high risk for diabetes (a previous history of gestational diabetes or prepregnancy BMI ≥30 kg/m2). Participants planning pregnancy or in the first half of pregnancy were parallel-group randomized into an intervention arm which received lifestyle counseling and a control arm which received usual care given at their local antenatal clinics. All participants visited a study nurse every three months before and during pregnancy, and at 6 weeks, 6 and 12 months postpartum. Measurements and laboratory tests were performed on all participants with special focus on dietary and exercise habits and metabolic markers.

Of the 728 women [mean age 32.5 years (SD 4.7); median parity 1 (range 0-9)] considered to be eligible for the study 235 were non-pregnant and 493 pregnant [mean gestational age 13 (range 6 to 18) weeks] at the time of enrollment. The proportion of nulliparous women was 29.8% (n = 217). Out of all participants, 79.6% of the non-pregnant and 40.4% of the pregnant women had previous gestational diabetes and 20.4% of the non-pregnant and 59.6% of the pregnant women were recruited because of a prepregnancy BMI ≥30 kg/m2. Mean BMI at first visit was 30.1 kg/m2 (SD 6.2) in the non-pregnant and 32.7 kg/m2 (SD 5.6) in the pregnant group.

Discussion

To our knowledge, this is the first randomized lifestyle intervention trial, which includes, besides the pregnancy period, both the prepregnancy and the postpartum period. This study design also provides an opportunity to focus upon the health of the next generation. The study is expected to produce novel information on the optimal timing and setting of interventions and for allocating resources to prevent obesity and diabetes in women of reproductive age.

Trial registration

Clinicaltrials.gov Identifier: NCT01698385

Keywords:
Gestational diabetes; Type 2 diabetes; Diet and exercise intervention; Obesity; BMI; Pregnancy