Condition category
Pregnancy and Childbirth
Date applied
21/11/2011
Date assigned
02/12/2011
Last edited
10/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When Diabetes Mellitus is first found during pregnancy it is called Gestational Diabetes Mellitus (GDM). Women with GDM have high levels of glucose (sugar) in their blood. This can have severe consequences for mothers and their children. Prevention of GDM is therefore important. The main aim of this study is to evaluate the effects of three interventions to prevent GDM.

Who can participate?
Obese pregnant women will be asked to volunteer in the study before 12 weeks of pregnancy.

What does the study involve?
This study looks at the effects of advice on physical activity, advice on diet, vitamin D supplementation, and combinations of these. Participants are randomly allocated to one of the several treatments that are compared. Those allocated to the lifestyle interventions (physical activity, diet or a combination of these two) will have personal contact with a lifestyle coach as soon as possible after inclusion in the study. The same coach will deliver the nutrition and/or physical activity interventions. Women will have five face-to-face sessions with their coach, and three telephone sessions. Women in the vitamin D groups will take vitamin D supplements until delivery. We will measure the levels of glucose and insulin in the women’s blood at the start of the study and at 24-28 and 35-38 weeks of pregnancy. Weight gain during pregnancy will also be measured.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
1. Institut de Recerca de l’Hospital de la Santa Creu, Barcelona, Spain
2. Cambridge University Hospitals (NHS) Cambridge, UK (trial coordinator)
3. Medical University, Vienna, Austria
4. Katholieke Universiteit, Leuven, Belgium
5. Copenhagen University Hospital, Copenhagen, Denmark
6. Akademia Medyczna im Karola Marcinkowskiego, Poznan, Poland
7.Università degli studi di Padova, Padova, Italy
8. National University of Ireland, Galway, Ireland
9. VU University Medical Center, Amsterdam, the Netherlands
10. University Hospital, Odense, Denmark

When is the study starting and how long is it expected to run for?
September 2012 to September 2014.

Who is funding the study?
European Union (EU) 7th Framework Programme for Research.

Who is the main contact?
Dr David Simmons (trial coordinator), david.simmons@addenbrookes.nhs.uk
Dr Mireille van Poppel (sponsor), mnm.vanpoppel@vumc.nl
Univ.-Prof. Dr. Gernot Desoye (DALI project coordinator), gernot.desoye@medunigraz.at

Trial website

http://www.dali-project.eu

Contact information

Type

Scientific

Primary contact

Dr David Simmons

ORCID ID

http://orcid.org/0000-0003-0560-0761

Contact details

University of Western Sydney
Locked Bag 1797
Penrith
NSW 2751
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1

Study information

Scientific title

DALI: Vitamin D And Lifestyle Intervention for gestational diabetes mellitus (GDM) prevention: a randomised controlled trial

Acronym

DALI

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

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial with a factorial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gestational diabetes

Intervention

Interventions section as of 09/06/2016:
The design is that of two trials with a factorial design:

Trial 1:
1. Physical activity (PA)
2. Diet
3. PA & diet
4. Control

Trial 2:
1. Vitamin D
2. PA & diet and placebo
3. Vitamin D & PA & diet
4. 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 on-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.

In the Vitamin D intervention, women will use 1600 IU vitamin D supplements per day from the start of the intervention until delivery.


Original Interventions section:
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.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/09/2012

Overall trial end date

01/09/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

880

Participant 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

Recruitment start date

01/09/2012

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Austria, Belgium, Denmark, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom

Trial participating centre

Addenbrooke's Treatment Centre
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

VU University Medical Center (Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/10/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23829946
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26112044

Publication citations

  1. Protocol

    Jelsma JG, van Poppel MN, Galjaard S, Desoye G, Corcoy R, Devlieger R, van Assche A, Timmerman D, Jans G, Harreiter J, Kautzky-Willer A, Damm P, Mathiesen ER, Jensen DM, Andersen L, Dunne F, Lapolla A, Di Cianni G, Bertolotto A, Wender-Oegowska E, Zawiejska A, Blumska K, Hill D, Rebollo P, Snoek FJ, Simmons D, DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol., BMC Pregnancy Childbirth, 2013, 13, 142, doi: 10.1186/1471-2393-13-142.

Additional files

Editorial Notes

10/06/2016: The contact information for the study contact has been updated, and the availability of the participant level data has been added. 09/06/2016: Publication reference added, and the interventions section has been updated.