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ISRCTN
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ISRCTN33885819
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DOI
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10.1186/ISRCTN33885819
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Primary prevention of gestational diabetes among women at risk: a cluster-randomized controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Women at risk (overweight, age 40 years or older, earlier macrosomic child, diabetic first stage relatives) will receive intensified diet and physical activity counselling, which prevents their gestational diabetes.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethical Committee of Pirkanmaa Hospital District. Approved on 24/02/2007. Amendments approved on 11/09/2007 (ref: R02630)
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Study design
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A cluster-randomized controlled trial.
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Countries of recruitment
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Finland
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Disease/condition/study domain
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Gestational diabetes
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Participants - inclusion criteria
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Pregnant women in their 8-12th pregnancy week and with at least one of the following criteria:
1. Body mass index at least 25 kg/m2
2. Age at least 40 years
3. History of gestational diabetes or macrosomic child
4. Type 1 or 2 diabetes in any of the first stage relatives
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Participants - exclusion criteria
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1. Age < 18 years
2. Type 1 or 2 diabetes before pregnancy
3. Twin pregnancy or otherwise problematic pregnancy based on physician's opinion
4. Physical disability preventing from exercising
5. Substance abuse or history of severe mental illness
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Anticipated start date
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15/09/2007
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600
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Interventions
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14 counties are participating in the trial. They are randomised to the intervention and control groups (7 counties each).
Intervention group: Intensified, tailored diet and physical activity counselling during five scheduled visits to a public health nurse in maternity health care. Visits take place at 8-9, 16-18, 22-24, 32-34 and 36-37 pregnancy weeks. In addition to physical activity counselling, participants have monthly meetings with peers guided by a physiotherapist.
Participants in the maternity health care in control counties receive usual care only.
(See ISRCTN21512277 for pilot study)
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Primary outcome measure(s)
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Prevention of gestational diabetes, assessed by:
1. Oral glucose tolerance test during pregnancy weeks 26-28
2. Weight of the newborn
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Secondary outcome measure(s)
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1. Maternal weight development. Maternal weight will be measured 5 times during pregnancy, on pregnancy weeks 8-9, 16-18, 22-24, 32-34 and 36-37, and 6-8 weeks after delivery.
2. Child weight development, followed one year after delivery.
3. Need of insulin treatment during pregnancy. This will be determined at time of possible GDM diagnosis (earliest 26-28th week of pregnancy based on Oral Glucose Tolerance Test [OGTT]).
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Sources of funding
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1. National Institutes of Health (USA)
2. Ministries of Education and Social Affairs and Health (Finland)
3. Diabetes Research Fund (Finland)
4. Pirkanmaa Hospital District (EVO) (Finland)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20682023
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21610860
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22950716
4. 2013 cost-effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/23457562
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Contact name
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Dr
Riitta
Luoto
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Address
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UKK Institute
post box 30
33501
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City/town
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Tampere
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Zip/Postcode
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33501
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Country
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Finland
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Email
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riitta.luoto@uta.fi
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Sponsor
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The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
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Address
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Post box 30
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City/town
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Tampere
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Zip/Postcode
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33501
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Country
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Finland
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Email
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uktutkimus@uta.fi
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Sponsor website:
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http://www.ukkinstituutti.fi/en/
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Date applied
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12/09/2007
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Last edited
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06/03/2013
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Date ISRCTN assigned
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03/10/2007
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