| Trial name or title |
Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial |
| Methods |
Randomised controlled trial that uses a 2‐by‐2 factorial design |
| Participants |
600 women, with less than 17 weeks' gestation at recruitment based on LMP, aged over 18 years, with a singleton pregnancy and aiming to give birth at local maternity (Princess Anne) hospital |
| Interventions |
Healthy conversation skills support plus vitamin D supplementation (1000 IU cholecalciferol) (n = 150); healthy conversation skills support plus placebo (n = 150); usual care plus vitamin D supplementation (n = 150); usual care plus placebo (n = 150) |
| Outcomes |
This trial is evaluating 2 approaches to improving maternal diet: a behaviour change intervention and vitamin D supplementation. The factorial design of this trial has the advantage of enabling each intervention be tested separately as well as allowing exploration of the synergistic effect of both interventions on women’s diets and vitamin D levels. |
| Starting date |
Registered on 13 September 2013 |
| Contact information |
Janis Baird: MRC Lifecourse Epidemiology Unit, University of Southampton,Southampton SO16 6YD, UK. jb@mrc.soton.ac.uk |
| Notes |
Sponsor: Medical Research Council,NIHR Southampton Nutrition Biomedical Research Centre and Danone Nutricia Early Life Nutrition. |
