UniSA Justice & Society, University of South Australia, Adelaide, South Australia, Australia.
Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, South Australia, Australia.
BMJ Open. 2022 Apr 26;12(4):e060520. doi: 10.1136/bmjopen-2021-060520.
Shift workers are at an increased risk of developing obesity and type 2 diabetes. Eating and sleeping out of synchronisation with endogenous circadian rhythms causes weight gain, hyperglycaemia and insulin resistance. Interventions that promote weight loss and reduce the metabolic consequences of eating at night are needed for night shift workers. The aim of this study is to examine the effects of three weight loss strategies on weight loss and insulin resistance (HOMA-IR) in night shift workers.
A multisite 18-month, three-arm randomised controlled trial comparing three weight loss strategies; continuous energy restriction; and two intermittent fasting strategies whereby participants will fast for 2 days per week (5:2); either during the day (5:2D) or during the night shift (5:2N). Participants will be randomised to a weight loss strategy for 24 weeks (weight loss phase) and followed up 12 months later (maintenance phase). The primary outcomes are weight loss and a change in HOMA-IR. Secondary outcomes include changes in glucose, insulin, blood lipids, body composition, waist circumference, physical activity and quality of life. Assessments will be conducted at baseline, 24 weeks (primary endpoint) and 18 months (12-month follow-up). The intervention will be delivered by research dietitians via a combination of face-to-face and telehealth consultations. Mixed-effect models will be used to identify changes in dependent outcomes (weight and HOMA-IR) with predictor variables of outcomes of group, time and group-time interaction, following an intention-to-treat approach.
The study protocol was approved by Monash Health Human Research Ethics Committee (RES 19-0000-462A) and registered with Monash University Human Research Ethics Committee. Ethical approval has also been obtained from the University of South Australia (HREC ID: 202379) and Ambulance Victoria Research Committee (R19-037). Results from this trial will be disseminated via conference presentations, peer-reviewed journals and student theses.
Australian New Zealand Clinical Trials Registry (ACTRN-12619001035112).
轮班工作者患肥胖症和 2 型糖尿病的风险增加。饮食和睡眠与内源性生物钟节律不同步会导致体重增加、高血糖和胰岛素抵抗。需要为夜班工作者提供促进体重减轻和减少夜间进食对代谢影响的干预措施。本研究旨在探讨三种减肥策略对夜班工作者体重减轻和胰岛素抵抗（HOMA-IR）的影响。
一项多中心、18 个月、三臂随机对照试验，比较三种减肥策略；持续能量限制；和两种间歇性禁食策略，即参与者每周禁食 2 天（5:2）；要么在白天（5:2D），要么在夜班期间（5:2N）。参与者将被随机分配到减肥策略 24 周（减肥阶段），并在 12 个月后（维持阶段）进行随访。主要结局是体重减轻和 HOMA-IR 的变化。次要结局包括葡萄糖、胰岛素、血脂、身体成分、腰围、身体活动和生活质量的变化。评估将在基线、24 周（主要终点）和 18 个月（12 个月随访）进行。干预措施将由研究营养师通过面对面和远程医疗咨询相结合的方式提供。采用混合效应模型，根据意向治疗方法，以组、时间和组-时间交互作用的预测变量，确定依赖结局（体重和 HOMA-IR）的变化。
该研究方案已获得莫纳什健康人类研究伦理委员会（RES 19-0000-462A）的批准，并在莫纳什大学人类研究伦理委员会注册。南澳大利亚大学（HREC ID：202379）和维多利亚救护车研究委员会（R19-037）也获得了伦理批准。该试验的结果将通过会议演讲、同行评议期刊和学生论文进行传播。
澳大利亚和新西兰临床试验注册中心（ACTRN-12619001035112）。
