The aim with the present study was to evaluate the effects and tolerability of Family Meals on Prescription, a 3-month intensive dietary intervention with a participatory approach on body mass index (BMI) and metabolic health in children living with obesity. In this prospective randomized controlled trial, children aged 5-15years were included from the Pediatric Obesity outpatient Clinics in Halland, Sweden. Participants were randomly assigned to receive lifestyle treatment with or without Family Meals on Prescription (FMP) consisting of a subsidized prepacked grocery bag including recipes and provisions for five Family Meals per week for 3months. The primary endpoint was changed in BMIz after 3, 12 and 18-24months and secondary endpoints included to assess tolerability of FMP and effects on metabolic biomarker and frequency of shared meals. Eighty-nine children (51.7% female) entered the study, 54 patients in the intervention group and 35 in the control group. There were no significant differences between the groups concerning gender, age or level of obesity at baseline. The Family Meal on Prescription intervention combined with lifestyle treatment led to a significantly greater reduction in BMIz than lifestyle treatment alone after the 3-month long intervention (- 0.17 vs + 0.01, p < 0.01); however, this difference was not sustained throughout the study period, and in fact, the control group had a greater reduction in BMIz after 18-24months.A subsidized prepacked grocery bag may be a novel, well-tolerated and effective tool in the treatment of childhood obesity. The fact that the BMIz reduction shown at the end of the intervention did not persist over time emphasized the need of long-term treatment. Registered at clinicaltrals.gov 27 Nov 2020, retrospectively registered: clinicaltrials.gov number 19002468. https://clinicaltrials.gov/study/NCT05225350 What is Known: • Swedish data shows that lifestyle treatment alone is not sufficient for many families undergoing treatment for childhood obesity. • Regular family meals and mealtime routines have been shown to be important for nutritional health and dietary patterns in children and adolescents. What is New: • This intervention with a participatory approach involving prepacked family meals was well tolerated and led to a significant reduction in BMIz during the intervention. • That fact that these results were not sustained over time indicates a need to evaluate longer interventions, and that childhood obesity is a chronic and complex disease which requires long-time treatments.
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