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

被引:20
|
作者
Baird, Janis [1 ]
Barker, Mary [1 ]
Harvey, Nicholas C. [1 ,2 ]
Lawrence, Wendy [1 ]
Vogel, Christina [1 ]
Jarman, Megan [3 ]
Begum, Rufia [1 ,2 ]
Tinati, Tannaze [1 ]
Mahon, Pamela [1 ]
Strommer, Sofia [1 ]
Rose, Taylor [1 ]
Inskip, Hazel [1 ]
Cooper, Cyrus [1 ,2 ]
机构
[1] Univ Southampton, MRC Lifecourse Epidemiol Unit, Southampton SO16 6YD, Hants, England
[2] Univ Southampton, NIHR Nutr Biomed Res Ctr, Southampton SO16 6YD, Hants, England
[3] Univ Alberta, Dept Agr Food & Nutr Sci, Li Ka Shing Ctr Hlth Res Innovat, Edmonton T6G 2E1, AB, Canada
基金
英国医学研究理事会;
关键词
YOUNG-WOMEN; HEALTH; BEHAVIOR; DIETARY; OSTEOPOROSIS; QUALITY;
D O I
10.1186/s13063-016-1603-y
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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
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页数:11
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