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

Area of Science:

• Maternal and infant health
• Nutritional science
• Public health interventions

Background:

• Maternal nutritional status significantly impacts fetal growth and infant development.
• Interventions targeting maternal nutrition and lifestyle can optimize fetal development and maternal well-being.
• Effective dietary improvements for women of childbearing age necessitate complex, culturally sensitive approaches.

Purpose of the Study:

• To evaluate the efficacy of behavior change (Healthy Conversation Skills) and vitamin D supplementation in improving pregnant women's diet quality and nutritional status.
• To explore the combined efficacy of behavior change and vitamin D supplementation.
• To assess the impact of these interventions on maternal vitamin D levels and diet quality.

Main Methods:

• A factorial design randomized controlled trial involving pregnant women (8-12 weeks gestation).
• Four groups: Healthy Conversation Skills + vitamin D, Healthy Conversation Skills + placebo, usual care + vitamin D, usual care + placebo.
• Primary outcomes: maternal diet quality and 25(OH) vitamin D levels. Secondary outcomes include self-efficacy, weight gain, and neonatal bone mineral content.

Main Results:

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Conclusions:

• This trial evaluates behavior change and vitamin D supplementation for improving maternal diet.
• The factorial design allows for individual and combined intervention efficacy assessment.
• The study aims to understand synergistic effects on maternal diet and vitamin D status.