DALI: finding the right intervention for the prevention of gestational diabetes

Phase 1

• Conditions: Gestational diabetes; MedDRA version: 14.1Level: LLTClassification code 10018210Term: Gestational diabetes mellitusSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-18
• Study Completion: 2016-01-31
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 154

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 < 17 weeks
• sufficiently fluent in major language of the country of recruitment
• being able to be moderately physically active
• giving written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 880
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• preexisting diabetes
• Diagnosed with (gestational) diabetes mellitus before randomisation defined as fasting glucose = 5.1 mmol/l and/or 1 hour glucose = 10 mmol/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