Southampton PRegnancy Intervention for the Next Generation (SPRING):protocol for a randomised controlled trial

Abstract

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN07227232 . Registered on 13 September 2013.

Publication DOI: https://doi.org/10.1186/s13063-016-1603-y
Divisions: College of Health & Life Sciences > School of Psychology
College of Health & Life Sciences
Additional Information: © 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Uncontrolled Keywords: Alcohol Drinking/adverse effects,Biomarkers/blood,Cholecalciferol/administration & dosage,Clinical Protocols,Communication,Counseling,Dietary Supplements,England,Female,Health Behavior,Health Knowledge, Attitudes, Practice,Healthy Diet,Hospitals, Maternity,Humans,Infant Nutritional Physiological Phenomena,Infant, Newborn,Maternal Nutritional Physiological Phenomena,Nutrition Assessment,Nutritional Status,Pregnancy,Research Design,Self Efficacy,Smoking/adverse effects,Surveys and Questionnaires,Time Factors,Treatment Outcome,Vitamin D/analogs & derivatives,Vitamins/administration & dosage
Publication ISSN: 1745-6215
Full Text Link:
Related URLs: https://trialsj ... 3063-016-1603-y (Publisher URL)
PURE Output Type: Article
Published Date: 2016-10-12
Accepted Date: 2016-09-14
Authors: Baird, Janis
Barker, Mary
Harvey, Nicholas C
Lawrence, Wendy
Vogel, Christina
Jarman, Megan (ORCID Profile 0000-0002-4477-9314)
Begum, Rufia
Tinati, Tannaze
Mahon, Pamela
Strommer, Sofia
Rose, Taylor
Inskip, Hazel
Cooper, Cyrus

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