Study protocol for the Shifting Weight using Intermittent Fasting in night shift workers (SWIFt) study: a three-arm randomised controlled trial comparing three weight loss strategies in night shift workers with obesity

被引:3
|
作者
Rogers, Michelle [1 ,2 ]
Coates, Alison [2 ,3 ]
Huggins, Catherine E. [4 ]
Dorrian, Jillian [1 ]
Clark, Angela B. [5 ]
Davis, Corinne [5 ]
Leung, Gloria K. W. [5 ]
Davis, Rochelle [5 ]
Phoi, Yan Yin [2 ,3 ]
Kellow, Nicole J. [5 ]
Iacovou, Marina [6 ,7 ]
Yates, Crystal L. [1 ,8 ]
Banks, Siobhan [1 ,8 ]
Sletten, Tracey L. [5 ,9 ]
Bonham, Maxine P. [5 ]
机构
[1] Univ South Australia, UniSA Justice & Soc, Adelaide, SA, Australia
[2] Univ South Australia, Alliance Res Exercise Nutr & Act ARENA, Adelaide, SA, Australia
[3] Univ South Australia, Allied Hlth & Human Performance, Adelaide, SA, Australia
[4] Deakin Univ, Inst Hlth Transformat, Burwood, Vic, Australia
[5] Monash Univ, Dept Nutr Dietet & Food, Notting Hill, Vic, Australia
[6] Hudson Inst Med Res, Ctr Innate Immun & Infect Dis, Clayton, Vic, Australia
[7] Monash Univ, Dept Mol & Translat Sci, Clayton, Vic, Australia
[8] Univ South Australia, Behav Brain Body Res Ctr, Adelaide, SA, Australia
[9] Monash Univ, Sch Psychol Sci, Turner Inst Brain & Mental Hlth, Notting Hill, Vic, Australia
来源
BMJ OPEN | 2022年 / 12卷 / 04期
基金
英国医学研究理事会;
关键词
NUTRITION & DIETETICS; SLEEP MEDICINE; PUBLIC HEALTH; ANXIETY STRESS SCALES; MORNINGNESS-EVENINGNESS QUESTIONNAIRE; PHYSICAL-ACTIVITY QUESTIONNAIRE; NORDIC SLEEP QUESTIONNAIRE; PSYCHOMETRIC PROPERTIES; NORMATIVE DATA; CALORIC-INTAKE; DEPRESSION; VALIDITY; VERSION;
D O I
10.1136/bmjopen-2021-060520
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
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页数:15
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