A cluster randomised controlled trial investigating the efficacy of family-centred obesity management program in primary care settings: A study protocol.

Abstract

The study aims to test the efficacy of a family-centred healthy lifestyle program in primary care health centres among children with overweight or obesity, evaluating the results at 3, 6, and 9 months post-intervention. A single-blind, randomised controlled cluster study where participants will be blinded to group assignment to reduce bias will be followed. The intervention comprises a 6-month program with intensive and maintenance behavioural therapies, including dietary modifications and guidelines for physical activity, administered by a multidisciplinary team. Participants will be assigned to an intervention group or a treatment-as-usual control group. Primary health centres in Seeb Wilayat, serving densely populated areas and willing to participate, will be included. Randomisation will be conducted at the cluster level to improve recruitment efficiency. A sample size calculation will ensure adequate power to detect significant differences. Ethical approval is granted and informed consent/assent will be obtained from all participants. The proposed study focusses on testing the efficacy of a family-centred healthy lifestyle program in primary care centres through a controlled, randomised study. Successful outcomes could lead to informed interventions, improvements in the health system, policy recommendations, positive community impacts, information on behavioural therapies, and improved long-term health outcomes for affected children and their families. This study will contribute to the literature by providing a culturally sensitive and evidence-based solution to a pressing public health issue, which can be adapted to similar contexts in Oman and beyond.