Primary prevention of gestational diabetes among women at risk: a cluster-randomized controlled trial

ISRCTN	ISRCTN33885819
DOI	https://doi.org/10.1186/ISRCTN33885819
Protocol serial number	N/A
Sponsor	The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Funders	National Institutes of Health (USA), Ministries of Education and Social Affairs and Health (Finland), Diabetes Research Fund (Finland), Pirkanmaa Hospital District (EVO) (Finland)

Submission date: 12/09/2007
Registration date: 03/10/2007
Last edited: 06/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Riitta Luoto
Scientific

UKK Institute
post box 30
33501
Tampere
33501
Finland

Email	riitta.luoto@uta.fi

Study information

Primary study design	Interventional
Study design	A cluster-randomized controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Ethical Committee of Pirkanmaa Hospital District. Approved on 24/02/2007. Amendments approved on 11/09/2007 (ref: R02630)
Health condition(s) or problem(s) studied	Gestational diabetes
Intervention	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)
Intervention type	Other
Primary outcome measure(s)	Prevention of gestational diabetes, assessed by: 1. Oral glucose tolerance test during pregnancy weeks 26-28 2. Weight of the newborn
Key secondary outcome measure(s)	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]).
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	600
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	15/09/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Finland

Study participating centre

UKK Institute

Tampere
33501
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	03/08/2010	Yes	No
Results article	results	01/05/2011	Yes	No
Results article	results	05/09/2012	Yes	No
Other publications	cost-effectiveness	01/09/2013	Yes	No