Trials (Oct 2022)
Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial
Abstract
Abstract Background Shift work is considered a risk factor for a number of chronic health conditions including obesity. Weight reduction in obese patients lowers the risk for cardiovascular disease, diabetes, certain cancers, and mortality. Achieving a negative energy balance by providing low-calorie meal replacements is widely used for weight management. This study aims to evaluate the impact of a low-calorie “meal-replacement” on the weight and metabolic parameters of shift workers with obesity. Methods This trial will be conducted in a parallel, randomized controlled design for a period of 8 weeks. A total of 44 shift workers with body mass index over 25 kg/m2 will be recruited after assessing eligibility. Participants will be randomly assigned to the test and control groups on a 1:1 ratio. The intervention group (N = 22) will be provided with a low-calorie (~200 kcal) meal replacement shake as dinner, and the control group (N = 22) will continue their habitual diets. The visits and the evaluations will be done as follows: screening (visit 0), 4 weeks (visit 1), and 8 weeks (visit 2). Anthropometric measurements will be taken at 0, 4, and 8 weeks. Body composition, biochemical parameters, dietary intake, and physical activity will be assessed during the first and the last visit. Outcomes The primary outcome will be the proportion of participants that had a 5% body weight loss from baseline. The secondary outcomes will be post-intervention changes in other metabolic parameters. Discussion To our knowledge, this is one of the first randomized controlled trials evaluating the effects of a meal replacement as the night meal for weight loss in shift workers with obesity. Moreover, improvement of metabolic parameters in shift workers will be an added benefit to this high-risk group. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000231741 . Registered on 09 February 2022.
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