Prevention of Gestational Diabetes

Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130012

Enrollment

440

Registered

2010-05-25

Start date

2005-04-30

Completion date

2006-12-31

Last updated

2010-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Gestational diabetes mellitus, Lifestyle intervention, Oral glucose tolerance test, Insulin treatment, Pregnancy outcomes

Brief 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

Detailed description

1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12 1. voluntary women in early pregnancy (n=96) 2. 54 high risk mothers were randomized * lifestyle intervention group (n=27) * close follow-up (n=27) 2. 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 3. 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 4. Primary outcomes * number of at risk participants developing GDM during pregnancy in the two arms 5. Secondary outcomes * the effect of intervention on fetal growth

Interventions

BEHAVIORALLifestyle: diet and exercise

Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.

BEHAVIORALClose follow-up: reporting diaries of food and exercise

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* high risk for gestational diabetes * fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT \<7.8 mmol/l

Exclusion criteria

* normal glucose tolerance at weeks 8-12 * gestational diabetes at weeks 8-12

Design outcomes

Primary

Measure	Time frame
Number of at risk participants developing GDM during pregnancy	—

Secondary

Measure	Time frame
The effect of intervention on fetal growth	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026