Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-08-25 DOI:10.1016/j.cct.2025.108050

Nicola Guess , Sarah Wane , Charlotte Albury , Penny Breeze , Alan Brennan , Jack B. Joyce , Ushma Galal , Elizabeth Morris , Carolyn Newbert , Caroline Mitchell , Ly-Mee Yu , Paul Aveyard , Susan A. Jebb

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引用次数: 0

Abstract

Background

The NHS Path to Remission (PtR) offers a total diet replacement (TDR) programme to help people newly-diagnosed with type 2 diabetes (T2D) lose weight. It is very effective for people who participate, but most eligible people do not take part.

Aim

To assess whether offering a range of weight loss programmes can increase uptake of, and persistence with, weight loss and lead to a higher proportion of the population achieving remission of T2D compared with offering PtR only.

Method

1788 people diagnosed with T2D in the last six years, who are willing to try to lose weight to achieve remission, will be recruited via GP practices and randomised to the NewDAWN service or PtR. Outcomes (weight, height, HbA1c, medications, BP, CVD risk score, PAID, EQ-5D, healthcare resource use) will be assessed at baseline and 12 months, with diabetes remission at 12 months as the primary outcome. An internal pilot assessment will follow 150 participants for 16 weeks to determine whether to progress using pre-specified criteria based on fidelity of programme delivery, adherence to the programme and change in weight. The decision will be reviewed by an external programme steering committee who will also advise on any other considerations they deem material to the likely successful completion of the full trial. A process evaluation will assess fidelity of delivery and collect both staff and participant feedback on the NewDAWN service to improve the effectiveness of implementation. The costs of NewDAWN and lifetime cost-effectiveness of the service will also be determined.

ISRCTN Registration: 11090437

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测试一种新的糖尿病适应性体重管理网络（NewDAWN）：一项随机对照试验方案

NHS缓解之路（PtR）提供了一个完全饮食替代（TDR）计划，以帮助新诊断为2型糖尿病（T2D）的人减肥。它对参加的人非常有效，但大多数符合条件的人不参加。目的评估与仅提供PtR相比，提供一系列减肥方案是否能增加减肥的吸收和坚持，并导致更高比例的人群实现T2D缓解。方法1788名在过去6年中被诊断为T2D的患者，他们愿意尝试减肥以达到缓解，将通过全科医生招募并随机分配到NewDAWN服务或PtR。结果（体重、身高、HbA1c、药物、血压、心血管疾病风险评分、PAID、EQ-5D、医疗资源使用）将在基线和12个月时进行评估，12个月时糖尿病缓解为主要结果。一项内部试点评估将对150名参与者进行为期16周的跟踪，以确定是否使用预先规定的基于方案交付保真度、对方案的遵守程度和权重变化的标准取得进展。该决定将由一个外部方案指导委员会进行审查，该委员会还将就他们认为可能成功完成全面试验的重要因素的任何其他考虑提供咨询意见。过程评估将评估交付的保真度，并收集工作人员和参与者对NewDAWN服务的反馈，以提高实施的有效性。还将确定NewDAWN的成本和服务的终身成本效益。ISRCTN注册号：11090437

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.