Panacea Index Logo

Command Palette

Search for a command to run...

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

Trials
January 1, 1970
Janis Baird et al. (13 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to test the efficacy of behavior change interventions and vitamin D supplementation, alone and combined, in improving maternal diet quality and nutritional status, which could influence breastfeeding outcomes.

Results Summary

The study evaluated maternal diet quality and vitamin D levels as primary outcomes, with secondary outcomes including breastfeeding status at one month postpartum, but specific breastfeeding efficacy results were not detailed in the abstract.

Population

Pregnant women (8-12 weeks gestation) attending a maternity hospital in Southampton.

Effective Dosage

Vitamin D supplementation (1000 IU cholecalciferol).

Duration

From 8-12 weeks gestation until 34 weeks gestation, with follow-up at one month postpartum.

Interactions

None mentioned

Extracted Claims (8)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Healthy Conversation Skills
increase
diet quality
pregnant women
-
improving
#1
Healthy Conversation Skills
increase
nutritional status
pregnant women
-
improving
#2
vitamin D supplementation (1000 IU cholecalciferol)
increase
diet quality
pregnant women
-
improving
#3
vitamin D supplementation (1000 IU cholecalciferol)
increase
nutritional status
pregnant women
-
improving
#4
Healthy Conversation Skills plus vitamin D supplementation
increase
diet quality
pregnant women
-
exploring the efficacy
#5
Healthy Conversation Skills plus vitamin D supplementation
increase
nutritional status
pregnant women
-
exploring the efficacy
#6
Healthy Conversation Skills plus vitamin D supplementation
increase
women's diets
pregnant women
-
exploring the synergistic effect
#7
Healthy Conversation Skills plus vitamin D supplementation
increase
vitamin D levels
pregnant women
-
exploring the synergistic effect
#8
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.

Medical Subject Headings (MeSH)
Alcohol DrinkingBiomarkersCholecalciferolClinical ProtocolsCommunicationCounselingDiet, HealthyDietary SupplementsEnglandFemaleHealth BehaviorHealth Knowledge, Attitudes, PracticeHospitals, MaternityHumansInfant Nutritional Physiological PhenomenaInfant, NewbornMaternal Nutritional Physiological PhenomenaNutrition AssessmentNutritional StatusPregnancyResearch DesignSelf EfficacySmokingSurveys and QuestionnairesTime FactorsTreatment OutcomeVitamin DVitamins
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations20
Citations/Year2.2
Relative Citation Ratio1.08
NIH Percentile53.2%
Research Impact Scores
APT Score0.75
Weight Score1.81
Normalized Score0.67
Related Supplements
Southampton PRegnancy Intervention for the Next Generation (... | Panacea Index