Condition category
Pregnancy and Childbirth
Date applied
12/09/2007
Date assigned
03/10/2007
Last edited
06/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Riitta Luoto

ORCID ID

Contact details

UKK Institute
post box 30
33501
Tampere
33501
Finland
riitta.luoto@uta.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Ethical Committee of Pirkanmaa Hospital District. Approved on 24/02/2007. Amendments approved on 11/09/2007 (ref: R02630)

Study design

A cluster-randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/09/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

600

Participant 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

Recruitment start date

15/09/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Finland

Trial participating centre

UKK Institute
Tampere
33501
Finland

Sponsor information

Organisation

The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research (Finland)

Sponsor details

Post box 30
Tampere
33501
Finland
uktutkimus@uta.fi

Sponsor type

Research organisation

Website

http://www.ukkinstituutti.fi/en/

Funders

Funder type

Government

Funder name

National Institutes of Health (USA)

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Ministries of Education and Social Affairs and Health (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diabetes Research Fund (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pirkanmaa Hospital District (EVO) (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Luoto RM, Kinnunen TI, Aittasalo M, Ojala K, Mansikkamäki K, Toropainen E, Kolu P, Vasankari T, Prevention of gestational diabetes: design of a cluster-randomized controlled trial and one-year follow-up., BMC Pregnancy Childbirth, 2010, 10, 39, doi: 10.1186/1471-2393-10-39.

  2. Results

    Luoto R, Kinnunen TI, Aittasalo M, Kolu P, Raitanen J, Ojala K, Mansikkamäki K, Lamberg S, Vasankari T, Komulainen T, Tulokas S, Primary prevention of gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial., PLoS Med., 2011, 8, 5, e1001036, doi: 10.1371/journal.pmed.1001036.

  3. Results

    Aittasalo M, Raitanen J, Kinnunen TI, Ojala K, Kolu P, Luoto R, Is intensive counseling in maternity care feasible and effective in promoting physical activity among women at risk for gestational diabetes? Secondary analysis of a cluster randomized NELLI study in Finland., Int J Behav Nutr Phys Act, 2012, 9, 104, doi: 10.1186/1479-5868-9-104.

  4. Kolu P, Raitanen J, Rissanen P, Luoto R, Cost-effectiveness of lifestyle counselling as primary prevention of gestational diabetes mellitus: findings from a cluster-randomised trial., PLoS ONE, 2013, 8, 2, e56392, doi: 10.1371/journal.pone.0056392.

Additional files

Editorial Notes