Table_1_Evaluation of the “Shifting Weight using Intermittent Fasting in night-shift workers” weight loss interventions: a mixed-methods protocol.DOCX

IntroductionShift workers are at a greater risk for obesity-related conditions. The impacts of working at night presents a challenge for designing effective dietary weight-loss interventions for this population group. The Shifting Weight using Intermittent Fasting in night-shift workers (SWIFt) study is a world-first, randomized controlled trial that compares three weight-loss interventions. While the trial will evaluate the effectiveness of weight-loss outcomes, this mixed-methods evaluation aims to explore for who weight-loss outcomes are achieved and what factors (intervention features, individual, social, organisational and wider environmental) contribute to this.MethodsA convergent, mixed-methods evaluation design was chosen where quantitative and qualitative data collection occurs concurrently, analyzed separately, and converged in a final synthesis. Quantitative measures include participant engagement assessed via: dietary consult attendance, fulfillment of dietary goals, dietary energy intake, adherence to self-monitoring, and rates for participant drop-out; analyzed for frequency and proportions. Regression models will determine associations between engagement measures, participant characteristics (sex, age, ethnicity, occupation, shift type, night-shifts per week, years in night shift), intervention group, and weight change. Qualitative measures include semi-structured interviews with participants at baseline, 24-weeks, and 18-months, and fortnightly audio-diaries during the 24-week intervention. Interviews/diaries will be transcribed verbatim and analyzed using five-step thematic framework analysis in NVivo. Results from the quantitative and qualitative data will be integrated via table and narrative form to interrogate the validity of conclusions.DiscussionThe SWIFt study is a world-first trial that compares the effectiveness of three weight-loss interventions for night shift workers. This mixed-methods evaluation aims to further explore the effectiveness of the interventions. The evaluation will determine for who the SWIFt interventions work best for, what intervention features are important, and what external factors need to be addressed to strengthen an approach. The findings will be useful for tailoring future scalability of dietary weight-loss interventions for night-shift workers.Clinical trial registration: This evaluation is based on the SWIFt trial registered with the Australian New Zealand Clinical Trials Registry [ACTRN 12619001035112].