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DALI: Vitamin D And Lifestyle Intervention for gestational diabetes mellitus (GDM) prevention
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| ISRCTN | ISRCTN70595832 |
| ClinicalTrials.gov identifier | |
| Public title |
DALI: Vitamin D And Lifestyle Intervention for gestational diabetes mellitus (GDM) prevention
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| Scientific title | DALI: Vitamin D And Lifestyle Intervention for gestational diabetes mellitus (GDM) prevention: a randomised controlled trial |
| Acronym | DALI |
| Serial number at source | Version 1 |
| Study hypothesis |
The DALI project aims to identify the best available measures to prevent GDM in an ongoing pregnancy.
Specific objectives are: 1. To compare the impact of increased physical activity, enhanced nutrition and Vitamin D supplementation either alone or in combination on maternal glucose tolerance, maternal weight gain and insulin sensitivity 2. To do an evaluation of barriers and promoters of uptake in life style changes 3. To provide a cost-benefit calculation of GDM prevention for health care systems |
| Lay summary | Lay summary under review |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial with a factorial design |
| Countries of recruitment | Austria, Belgium, Denmark, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom |
| Disease/condition/study domain | Gestational diabetes |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/09/2012 |
| Anticipated end date | 01/09/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 880 |
| Interventions |
The design is that of two trials with a factorial design:
1. Physical activity (PA) 2. Diet 3. PA & diet 4. Control 5. Vitamin D 6. PA & diet and placebo 7. Vitamin D & PA & diet 8. Placebo In each of the lifestyle interventions (physical activity, diet or a combination of these two), women will have personal contact with the lifestyle coach as soon as possible after randomisation. The same coach will deliver the nutrition and/or physical activity interventions. Each coach will have a desk-file outlining the intervention and options in detail. The first phase of behaviour change for both physical activity and diet is centred around intention formation. Education on risks and benefits, enhancing positive outcome expectancies and self-efficacy beliefs will be the primary task, translating into goal setting, action planning and reinforcement. Following realistic goal setting, the women need to be encouraged and supported in their efforts to eat healthy and/or to be sufficiently physically active. During this action phase behavioural strategies will be provided (e.g. cueing, mental imaging, self-monitoring) along with mobilising social support and identifying and overcoming obstacles where possible. The support programme builds on patient empowerment and cognitive behavioural principles, utilising techniques from Motivational Interviewing. In the programme, one-to-one contact will be offered, along with telephone booster calls. The same amount of time will be offered to each participant during the trial. The intervention will be provided in five sessions of approximately 30-45 minutes, and in four telephone calls of approximately 20 minutes. The one-to-one sessions will take place at the home of the participants or in hospital / midwife practice / general practice, depending on cultural acceptability of home visits. The doses of Vitamin D that will be tested in the dosing study are 500, 1000 and 1500 IU/day. One of these doses will be used in the trial. |
| Primary outcome measure(s) |
1. Weight gain during pregnancy: women will be weighed at all three measurements, with a calibrated scale (Seca)
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 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 |
| Secondary outcome measure(s) |
Maternal parameters:
1. HbA1c, fasting C peptide, leptin, triglycerides, free fatty acids, high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C), adiponectin 2. 3 beta-hydroxy-butyrate will be used as measures of alternative fuel supply; the latter also potentially a measure of excess weight loss and for safety studies 3. Blood pressure 4. C-reactive protein (CRP) will be measured as an indication for maternal inflammation 5. Change in physical activity will be assessed with a validated physical activity questionnaire and by accelerometer 6. Change in dietary habits will be assessed with a short food frequency questionnaire 7. All costs related to pregnancy and delivery: direct health care and non-health care costs and indirect non-health care costs will be assessed prospectively by questionnaires Foetal parameters: 1. For the assessment of how GDM affects the foetus, antenatal growth protocols for the following measurements will be developed: neonatal growth, adiposity, adipo-insular axis, glucose-insulin axis, electrolyte concentrations, clinical outcomes and hypoxia exposure at birth. Clinical measurements will be performed in all trial centers, laboratory measurements in the central laboratory on the samples collected in all trial centers. This will include: 1.1. Prenatally standardised ultrasound assessment of classic foetal growth parameters [biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), femur length (FL)] and determinants of foetal body composition variables (lean body mass and fat body mass). 1.2. At birth the following parameters will be recorded: Placental weight, birth weight and length, head and abdominal circumference, skin fold thickness (subcutaneous adipose tissue). In addition cord blood (arterial and venous) will be collected by all centers and sent to the central laboratory to measure C-peptide, glucose, leptin, triglycerides, 3- beta-hydroxy-butyric acid, pH and erythropoietin (EPO). A serum store will be kept for future analyses (where sufficient is available). 1.3. After birth clinical outcomes such as jaundice, hypocalcaemia, hypomagnesaemia, neonatal intensive care unit (NICU) admission, respiratory distress will be recorded |
| Sources of funding | European Union (EU) (Belgium) - Seventh Framework Programme (FP7) |
| Trial website | http://www.dali-project.eu |
| Publications | |
| Contact name | Dr David Simmons |
| Address |
Addenbrooke's Treatment Centre
Hills Road |
| City/town | Cambridge |
| Zip/Postcode | CB2 0QQ |
| Country | United Kingdom |
| Sponsor | VU University Medical Center (Netherlands) |
| Address | Van der Boechorststraat 7 |
| City/town | Amsterdam |
| Zip/Postcode | 1081 BT |
| Country | Netherlands |
| Date applied | 21/11/2011 |
| Last edited | 02/12/2011 |
| Date ISRCTN assigned | 02/12/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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