Contemporary clinical trials · 2025
Testing a New Diabetes Adaptive Weight management Network (NewDAWN): A protocol for a randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Guess Nicola, Wane Sarah, Albury Charlotte, Breeze Penny, Brennan Alan, Joyce Jack B, Galal Ushma, Morris Elizabeth, Newbert Carolyn, Mitchell Caroline, Yu Ly-Mee, Aveyard Paul, Jebb Susan A
Аннотация
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.
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.