Primary prevention of gestational diabetes among women at risk: a cluster-randomized controlled trial
| ISRCTN | ISRCTN33885819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33885819 |
| Secondary identifying numbers | N/A |
- 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
Scientific
UKK Institute
post box 30
33501
Tampere
33501
Finland
| riitta.luoto@uta.fi |
Study information
| Study design | A cluster-randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | Prevention of gestational diabetes, assessed by: 1. Oral glucose tolerance test during pregnancy weeks 26-28 2. Weight of the newborn |
| Secondary outcome measures | 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]). |
| Overall study start date | 15/09/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
33501
Finland
Sponsor information
The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)
Research organisation
Research organisation
Post box 30
Tampere
33501
Finland
| uktutkimus@uta.fi | |
| Website | http://www.ukkinstituutti.fi/en/ |
"ROR" |
https://ror.org/05ydecq02 |
Funders
Funder type
Government
National Institutes of Health (USA)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Institutos Nacionales de la Salud, US National Institutes of Health, NIH
- Location
- United States of America
Ministries of Education and Social Affairs and Health (Finland)
No information available
Diabetes Research Fund (Finland)
No information available
Pirkanmaa Hospital District (EVO) (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | 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 |
