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一项旨在改善孕期健康行为和维生素D状况的随机对照试验的过程评估:SPRING试验的实施

Process evaluation of a randomised controlled trial aimed at improving health behaviours and vitamin D status during pregnancy: Implementation of the SPRING trial.

作者信息

Proebstl Simone, Vogel Christina, Lawrence Wendy, Strömmer Sofia, Inskip Hazel, Hammond Julia, Hart Kate, McGill Karen, Harvey Nicholas C, Barker Mary, Baird Janis

机构信息

Institute for Medical Information Processing, Biometry, and Epidemiology - IBE, LMU Munich, Munich, Germany.

Pettenkofer School of Public Health, Munich, Germany.

出版信息

PLoS One. 2025 Sep 15;20(9):e0319224. doi: 10.1371/journal.pone.0319224. eCollection 2025.

DOI:10.1371/journal.pone.0319224
PMID:40953047
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12435722/
Abstract

BACKGROUND

The Southampton PRegnancy Intervention for the Next Generation (SPRING) aimed to assess the efficacy of vitamin D supplementation and the behaviour change intervention 'Healthy Conversation Skills' (HCS) in improving the nutritional status of pregnant women. This paper describes the implementation of these interventions. Efficacy of HCS in improving diet quality and physical activity was evaluated in subgroups of women who discussed ways to improve these behaviours.

METHODS

In total, 717 pregnant women were recruited from a maternity hospital in Southampton, England. Quantitative data were collected using questionnaires, case report forms, and audio recordings. Following Medical Research Council guidance, fidelity, dose, and reach were evaluated descriptively. Multiple linear regression models were produced for subgroup analyses.

RESULTS

Research nurses demonstrated high competence in using HCS. Compliance with intervention protocols for delivering and receiving both interventions was high. Participants took a median of 96% of the supplements and most women (85%) attended all four Healthy Conversations sessions. Women of lower socioeconomic status and from ethnic minorities were under-represented amongst participants. Findings were not sufficient to suggest an effect of HCS on diet quality among those who discussed diet but indicated a marginally beneficial effect on physical activity among those who discussed physical activity. Results suggested a weak dose-dependent effect, with the most pronounced difference in physical activity between the control group and the intervention sub-group with the highest exposure (adjusted difference 0.16 SD (95%-CI -0.03; 0.34)).

CONCLUSION

This process evaluation confirms that the intervention components were delivered with high fidelity and rates of compliance. Altering dietary behaviours proved more challenging than altering physical activity behaviours. Research is needed to explore barriers to healthy eating faced by women during pregnancy and how these can be overcome. This paper also highlights the difficulty of engaging people from ethnic minorities and disadvantaged backgrounds in research.

摘要

背景

南安普顿下一代孕期干预研究(SPRING)旨在评估补充维生素D以及行为改变干预措施“健康沟通技巧”(HCS)对改善孕妇营养状况的效果。本文描述了这些干预措施的实施情况。在讨论改善这些行为方式的女性亚组中,评估了HCS对改善饮食质量和身体活动的效果。

方法

总共从英国南安普顿的一家妇产医院招募了717名孕妇。使用问卷、病例报告表和录音收集定量数据。遵循医学研究理事会的指导方针,对保真度、剂量和覆盖范围进行了描述性评估。建立多元线性回归模型进行亚组分析。

结果

研究护士在使用HCS方面表现出很高的能力。两种干预措施的实施和接受的干预方案依从性都很高。参与者服用补充剂的中位数为96%,大多数女性(85%)参加了所有四次健康沟通课程。社会经济地位较低和少数族裔的女性在参与者中所占比例较低。研究结果不足以表明HCS对讨论饮食的人群的饮食质量有影响,但表明对讨论身体活动的人群的身体活动有轻微的有益影响。结果显示出微弱的剂量依赖性效应,对照组与暴露程度最高的干预亚组之间在身体活动方面的差异最为明显(调整后差异为0.16标准差(95%置信区间为-0.03;0.34))。

结论

该过程评估证实干预措施的各个组成部分以高保真度和依从率实施。改变饮食行为比改变身体活动行为更具挑战性。需要开展研究来探索孕期女性面临的健康饮食障碍以及如何克服这些障碍。本文还强调了让少数族裔和弱势群体参与研究的困难。

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