Trial reportTrials2016
Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2024Pooled it
- Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy.The Cochrane database of systematic reviews · 2024Pooled it
- Vitamin D supplementation for term breastfed infants to prevent vitamin D deficiency and improve bone health.The Cochrane database of systematic reviews · 2020Pooled it
- Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2019Pooled it
- Trial
- How can we best use opportunities provided by routine maternity care to engage women in improving their diets and health?Maternal & child nutrition · 2020Trial
- Article
- Bone resorption and dietary calcium in pregnancy-a window to future maternal bone health.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021Article
- The importance of maternal pregnancy vitamin D for offspring bone health: learnings from the MAVIDOS trial.Therapeutic advances in musculoskeletal disease · 2021Review
- Improving pregnant women's diet and physical activity behaviours: the emergent role of health identity.BMC pregnancy and childbirth · 2020Article
- Before the beginning: nutrition and lifestyle in the preconception period and its importance for future health.Lancet (London, England) · 2018Review
- Improving recruitment to clinical trials during pregnancy: A mixed methods investigation.Social science & medicine (1982) · 2018Article
- Response to Letter: Genetics and Vitamin D Supplementation in Pregnancy.The Journal of clinical endocrinology and metabolism · 2017Article
- Gestational vitamin D and childhood bone health.The lancet. Diabetes & endocrinology · 2017Article
- Analysis of the MAVIDOS trial - Author's reply.The lancet. Diabetes & endocrinology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundThe 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/
designWomen 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 registrationISRCTN07227232 . Registered on 13 September 2013.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.