Vitamin D and lifestyle Intervention for gestational diabetes mellitus (GDM) preventio

Not Applicable

Completed

• Conditions: Gestational diabetes; Pregnancy and Childbirth; Diabetes mellitus in pregnancy

• Registration Number: ISRCTN70595832
• Lead Sponsor: VU University Medical Center (Netherlands)

Brief Summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23829946 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26112044 2017 process evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/28882133 2018 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/29540227 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31182492 (added 15/04/2020) 2019 review in https://pubmed.ncbi.nlm.nih.gov/31845115/ (added 28/05/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-02
• Study Completion: 2014-09-01
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 880

Inclusion Criteria

1. Pre-pregnancy body mass index (BMI) (self-reported weight, measured height) is >= 29 kg/m2)
2. Aged 18 years or more
3. Gestational age at recruitment < 12 weeks
4. Sufficiently fluent in major language of the country of recruitment
5. Being able to be moderately physically active
6. Giving written informed consent
7. Agree to give birth in one of the participating hospitals

Exclusion Criteria

1. Pre-existing diabetes
2. 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
3. Not able to walk at least 100 meters safely
4. Requirement for complex diets
5. Advanced chronic conditions (eg valvular heart disease)
6. Sgnificant psychiatric disease
7. Unable to speak major language of the country of recruitment fluently
8. Known abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria) or hypercalciuria detected at screening (0.6 mmol/mmol creatinine in spot morning urine)
9. Twin pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Weight gain during pregnancy: women will be weighed at all three measurements, with a calibrated scale (Seca)<br> 2. Fasting plasma glucose: The fasting plasma glucose test is performed after a person has fasted for at least 8 hours. A sample of blood is taken from a vein (antecubital region) in the arm<br> 3. Insulin sensitivity will be measured using Homeostatic Model Assessment (HOMA), Quantitative insulin sensitivity check index (QUICKIE) and oral glucose insulin sensitivity (OGIS). OGIS also enables evaluation of insulin secretion. First phase insulin response will be calculated from the fasting and 30 min samples<br>