Prevention of Gestational Diabetes

NCT01130012 | Completed

• 1 other identifier: KUH16032005
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gestational Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of at risk participants developing GDM during pregnancy

Secondary Outcomes (1)

• The effect of intervention on fetal growth

Study Arms (2)

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.

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.

Behavioral: Close follow-up: reporting diaries of food and exercise

Interventions

Lifestyle: diet and exercise BEHAVIORAL

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

Lifestyle, follow-up, early care, standard care high/low risk

Close follow-up: reporting diaries of food and exercise BEHAVIORAL

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.

Close follow-up

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• South Ostrobothnia Hospital District: collaborator

Related Publications (2)

• 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.

  PMID: 22898328 DERIVED

• Korpi-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.

  PMID: 21429234 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eeva Korpi-Hyövälti, MD

  South Ostrobothnia Hospital District

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 25, 2010
• Study Start: April 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: December 1, 2006
• Last Updated: December 15, 2010

Record last verified: 2010-12