Gestational DiabetesNCT01130012
Prevention of Gestational Diabetes
A study testing Lifestyle: diet and exercise and Close follow-up: reporting diaries of food and exercise in people with Gestational Diabetes, run by Kuopio University Hospital.
Trial summary
Gestational diabetes mellitus (GDM)is a major health problem growing prevalence of obesity the older age of pregnant women A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM. feasibility of an early intervention glucose tolerance at weeks 26-28 Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Lifestyle: diet and exercise and Close follow-up: reporting diaries of food and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- high risk for gestational diabetes
- fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l
Who cannot join
- normal glucose tolerance at weeks 8-12
- gestational diabetes at weeks 8-12
About this study
Official title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
Gestational diabetes mellitus (GDM)is a major health problem
- growing prevalence of obesity
- the older age of pregnant women
A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.
- feasibility of an early intervention
- glucose tolerance at weeks 26-28
Read the detailed description
- A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12
- voluntary women in early pregnancy (n=96)
- 54 high risk mothers were randomized
- lifestyle intervention group (n=27)
- close follow-up (n=27)
- An OGTT was performed again at weeks 26-28
- the lifestyle intervention group (n=27)
- the close follow-up group (n=27)
- other high-risk women of the early care group (n=42)who were not randomized
- An OGTT was also performed at weeks 26-28 in two neighboring municipalities
- a standard care high-risk group(n=171)who did not undergo early intervention
- Primary outcomes
- number of at risk participants developing GDM during pregnancy in the two arms
- Secondary outcomes
- the effect of intervention on fetal growth
- Conditions
- Gestational Diabetes
- Being tested
- Lifestyle: diet and exercise, Close follow-up: reporting diaries of food and exercise
- Keywords
- Gestational diabetes mellitus, Lifestyle intervention, Oral glucose tolerance test, Insulin treatment, Pregnancy outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle: diet and exerciseBehavioural
Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
Close follow-up: reporting diaries of food and exerciseBehavioural
Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle, follow-up, early care, standard care high/low risk | Other | Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy. Receives: Behavioral: Lifestyle: diet and exercise |
| Close follow-up | Other | Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly. Receives: Behavioral: Close follow-up: reporting diaries of food and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of at risk participants developing GDM during pregnancy
Secondary outcomes (1)
The effect of intervention on fetal growth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startApr 2005
- Primary completionMay 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South Ostrobothnia Hospital District
- Investigators
- Eeva Korpi-Hyövälti, MD, Principal investigator, South Ostrobothnia Hospital District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130012
- Sponsor's protocol ID
- KUH16032005
- Status last verified
- Dec 2010
- First submitted
- 11 May 2010
- Last updated
- 15 Dec 2010
- Results posted
- No
Publications
Korpi-Hyovalti E, Heinonen S, Schwab U, Laaksonen DE, Niskanen L. Effect of intensive counselling on physical activity in pregnant women at high risk for gestational diabetes mellitus. A clinical study in primary care. Prim Care Diabetes. 2012 Dec;6(4):261-8. doi: 10.1016/j.pcd.2012.07.004. Epub 2012 Aug 13.
PubMed 22898328Korpi-Hyovalti EA, Laaksonen DE, Schwab US, Vanhapiha TH, Vihla KR, Heinonen ST, Niskanen LK. Feasibility of a lifestyle intervention in early pregnancy to prevent deterioration of glucose tolerance. BMC Public Health. 2011 Mar 24;11:179. doi: 10.1186/1471-2458-11-179.
PubMed 21429234
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?
- ClinicalTrials.gov ID
- NCT01130012
- Acronym / sponsor ID
- KUH16032005
- Conditions
- Gestational Diabetes
- Keywords
- Gestational diabetes mellitus, Lifestyle intervention, Oral glucose tolerance test, Insulin treatment, Pregnancy outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- South Ostrobothnia Hospital District
- Study start
- Apr 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gestational diabetes mellitus (GDM)is a major health problem
- growing prevalence of obesity
- the older age of pregnant women
A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.
- feasibility of an early intervention
- glucose tolerance at weeks 26-28
Detailed description
- A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12
- voluntary women in early pregnancy (n=96)
- 54 high risk mothers were randomized
- lifestyle intervention group (n=27)
- close follow-up (n=27)
- An OGTT was performed again at weeks 26-28
- the lifestyle intervention group (n=27)
- the close follow-up group (n=27)
- other high-risk women of the early care group (n=42)who were not randomized
- An OGTT was also performed at weeks 26-28 in two neighboring municipalities
- a standard care high-risk group(n=171)who did not undergo early intervention
- Primary outcomes
- number of at risk participants developing GDM during pregnancy in the two arms
- Secondary outcomes
- the effect of intervention on fetal growth
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle, follow-up, early care, standard care high/low risk | Other | Behavioral: Lifestyle: diet and exerciseLifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy. |
| Close follow-up | Other | Behavioral: Close follow-up: reporting diaries of food and exerciseFollow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- high risk for gestational diabetes
- fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l
Key exclusion criteria (2 listed)
- normal glucose tolerance at weeks 8-12
- gestational diabetes at weeks 8-12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle: diet and exerciseLifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy. | Behavioural | Lifestyle, follow-up, early care, standard care high/low risk |
| Close follow-up: reporting diaries of food and exerciseFollow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly. | Behavioural | Close follow-up |
Primary outcome
Number of at risk participants developing GDM during pregnancy
1 secondary outcome
The effect of intervention on fetal growth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
- Derived from this study: PubMed 22898328Korpi-Hyovalti E, Heinonen S, Schwab U, Laaksonen DE, Niskanen L. Effect of intensive counselling on physical activity in pregnant women at high risk for gestational diabetes mellitus. A clinical study in primary care. Prim Care Diabetes. 2012 Dec;6(4):261-8. doi: 10.1016/j.pcd.2012.07.004. Epub 2012 Aug 13.
- Derived from this study: PubMed 21429234Korpi-Hyovalti EA, Laaksonen DE, Schwab US, Vanhapiha TH, Vihla KR, Heinonen ST, Niskanen LK. Feasibility of a lifestyle intervention in early pregnancy to prevent deterioration of glucose tolerance. BMC Public Health. 2011 Mar 24;11:179. doi: 10.1186/1471-2458-11-179.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eeva Korpi-Hyövälti, MD principal investigator
South Ostrobothnia Hospital District
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle: diet and exercise and Close follow-up: reporting diaries of food and exercise in people with Gestational Diabetes, run by Kuopio University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of at risk participants developing GDM during pregnancy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.