DALI: finding the right intervention for the prevention of gestationaldiabetes

• Conditions: Gestational diabetes; MedDRA version: 16.0Level: LLTClassification code 10012606Term: Diabetes mellitus gestationalSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2013-000789-13-AT
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 440

Inclusion Criteria

• pre-pregnancy BMI (self-reported weight, measured height) is = 29 kg/m2)
• aged 18 years or more
• singleton pregnancy
• gestational age at recruitment < 20 weeks
• sufficiently fluent in major language of the country of recruitment
• being able to be moderately physically active
• giving written informed consent
• agreeing to give birth in one of the participating hospitals
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

• pre-existing diabetes
• diagnosed with (gestational) diabetes mellitus before randomisation defined as fasting glucose = 5.1 mmol/l and/or 1 hour glucose = 10mmol/l and/or 2 hour glucose =8.5 mmol/l at baseline measurement.
• not able to walk at least 100 meters safely
• requirement for complex diets
• advanced chronic conditions (e.g. valvular heart disease)
• significant psychiatric disease
• unable to speak major language of the country of recruitment fluently

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified