DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

Who Took Part

The abstract describes 880 women taking part.

The age groups tagged for this paper are teenagers, young adults and adults, women only.

Pregnant women at risk of GDM (BMI ≥ 29 (kg/m(2))) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation.

In total, 880 women will be included with 110 women allocated to each arm.

How the Study Was Run

In design terms this was a randomized and placebo-controlled study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing.

The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5 kg and either 7 healthy eating 'messages' and/or 5 physical activity 'messages' depending on randomization.

Fidelity is monitored by the use of a personal digital assistance (PDA) system.

Data is collected at baseline measurement, at 24-28 weeks, 35-37 weeks of gestation and after delivery.

Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight.

What Was Measured

PubMed files the paper under topics including Blood Glucose, Diabetes, Gestational, Diet, Dietary Supplements, Europe, Insulin Resistance and Life Style.

What This Means in Plain Language

The paper is a randomized and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 880 women.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 1 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2013 (BMC pregnancy and childbirth), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.