title: Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial.
abstract: The nutritional status and health of mothers influence the growth and development of infants during pregnancy and postnatal life. Interventions that focus on improving the nutritional status and lifestyle of mothers have the potential to optimise the development of the fetus as well as improve the health of mothers themselves. Improving the diets of women of childbearing age is likely to require complex interventions that are delivered in a socially and culturally appropriate context. In this study we aim to test the efficacy of two interventions: behaviour change (Healthy Conversation Skills) and vitamin D supplementation, and to explore the efficacy of an intervention that combines both, in improving the diet quality and nutritional status of pregnant women.
  
  
  
  Women attending the maternity hospital in Southampton are recruited at between 8 and 12 weeks gestation. They are randomised to one of four groups following a factorial design: 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). Questionnaire data include parity, sunlight exposure, diet assessment allowing assessment of diet quality, cigarette and alcohol consumption, well-being, self-efficacy and food involvement. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH) vitamin D. Maternal diet quality and 25(OH) vitamin D are the primary outcomes. Secondary outcomes are women's level of self-efficacy at 34 weeks, pregnancy weight gain, women's self-efficacy and breastfeeding status at one month after birth and neonatal bone mineral content, assessed by DXA within the first 14 days after birth.
  
  
  
  This trial is evaluating two 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 to be tested separately as well as allowing exploration of the synergistic effect of both interventions on women's diets and vitamin D levels.
  
  
  
  ISRCTN07227232 . Registered on 13 September 2013.
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK. jb@mrc.soton.ac.uk.
authors.forename: Janis
authors.identifier: 0000-0002-4039-4361
authors.initials: J
authors.lastname: Baird
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Barker
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.|NIHR Nutrition Biomedical Research Centre, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Nicholas C
authors.initials: NC
authors.lastname: Harvey
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Lawrence
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Christina
authors.initials: C
authors.lastname: Vogel
authors.affiliation: Li Ka Shing Centre for Health Research Innovation, Department of Agriculture, Food and Nutritional Science, University of Alberta, Edmonton, T6G 2E1, Alberta, Canada.
authors.forename: Megan
authors.initials: M
authors.lastname: Jarman
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.|NIHR Nutrition Biomedical Research Centre, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Rufia
authors.initials: R
authors.lastname: Begum
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Tannaze
authors.initials: T
authors.lastname: Tinati
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Pamela
authors.initials: P
authors.lastname: Mahon
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Sofia
authors.initials: S
authors.lastname: Strommer
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Taylor
authors.initials: T
authors.lastname: Rose
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Hazel
authors.initials: H
authors.lastname: Inskip
authors.affiliation: MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.|NIHR Nutrition Biomedical Research Centre, University of Southampton, Southampton, SO16 6YD, UK.
authors.forename: Cyrus
authors.initials: C
authors.lastname: Cooper
mesh_terms: D000428:Alcohol Drinking / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D002762:Cholecalciferol / Q000008:administration & dosage*; D002985:Clinical Protocols; D003142:Communication; D003376:Counseling; D000072001:Diet, Healthy; D019587:Dietary Supplements; D004739:England; D005260:Female; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006771:Hospitals, Maternity; D006801:Humans; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D039382:Maternal Nutritional Physiological Phenomena; D015596:Nutrition Assessment; D009752:Nutritional Status; D011247:Pregnancy; D012107:Research Design; D020377:Self Efficacy; D012907:Smoking / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D015415:Biomarkers; D014815:Vitamins; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D