Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
BMJ Open. 2022 Feb 15;12(2):e050006. doi: 10.1136/bmjopen-2021-050006.
The high cost of many healthy foods poses a challenge to maintaining optimal blood glucose levels for adults with type 2 diabetes mellitus who are experiencing food insecurity, leading to diabetes complications and excess acute care usage and costs. Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid acute care use. We will use a type 2 hybrid-effectiveness design to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of a healthy food prescription incentive programme for adults experiencing food insecurity and persistent hyperglycaemia. A randomised controlled trial (RCT) will investigate programme effectiveness via impact on glycosylated haemoglobin (primary outcome), food insecurity, diet quality and other clinical and patient-reported outcomes. A modelling study will estimate longer-term programme effectiveness in reducing diabetes-related complications, resource use and costs. An implementation study will examine all RE-AIM domains to understand determinants of effective implementation and reasons behind programme successes and failures.
594 adults who are experiencing food insecurity and persistent hyperglycaemia will be randomised to a healthy food prescription incentive (n=297) or a healthy food prescription comparison group (n=297). Both groups will receive a healthy food prescription. The incentive group will additionally receive a weekly incentive (CDN$10.50/household member) to purchase healthy foods in supermarkets for 6 months. Outcomes will be assessed at baseline and follow-up (6 months) in the RCT and analysed using mixed-effects regression. Longer-term outcomes will be modelled using the UK Prospective Diabetes Study outcomes simulation model-2. Implementation processes and outcomes will be continuously measured via quantitative and qualitative data.
Ethical approval was obtained from the University of Calgary and the University of Alberta. Findings will be disseminated through reports, lay summaries, policy briefs, academic publications and conference presentations.
NCT04725630.
Version 1.1; February 2022.
对于患有 2 型糖尿病且面临食物不安全问题的成年人来说，许多健康食品的高成本给他们维持最佳血糖水平带来了挑战，导致糖尿病并发症以及过多的急性护理使用和成本增加。健康食品处方计划可能会减少食物不安全状况，并支持患者改善饮食质量，预防糖尿病并发症并避免急性护理的使用。我们将使用 2 型混合有效性设计来研究为面临食物不安全和持续高血糖的成年人提供健康食品处方激励计划的可及性、有效性、采用、实施和维持（RE-AIM）。一项随机对照试验（RCT）将通过对糖化血红蛋白（主要结局）、食物不安全、饮食质量和其他临床及患者报告结局的影响来调查该计划的有效性。一项建模研究将估算该计划在降低糖尿病相关并发症、资源使用和成本方面的长期有效性。一项实施研究将调查所有 RE-AIM 领域，以了解有效实施的决定因素以及该计划成功和失败的原因。
594 名面临食物不安全和持续高血糖的成年人将被随机分配到健康食品处方激励组（n=297）或健康食品处方对照组（n=297）。两组都将收到健康食品处方。激励组还将获得每周 10.50 加元/家庭的激励（加元），以在 6 个月内购买超市的健康食品。RCT 将在基线和随访（6 个月）时评估结果，并使用混合效应回归进行分析。使用 UKPDS 结局模拟模型-2 对长期结果进行建模。通过定量和定性数据连续测量实施过程和结果。
卡尔加里大学和阿尔伯塔大学已获得伦理批准。研究结果将通过报告、通俗易懂的摘要、政策简报、学术出版物和会议演讲进行传播。
NCT04725630。
第 1.1 版；2022 年 2 月。
