Effect of a home-based physical activity program on metabolic syndrome in Ghanaian adults with type 2 diabetes: Protocol for a feasibility randomized controlled trial

Aim: To describe the protocol of a feasibility trial designed to test the preliminary effect of a 12-week culturally appropriate physical activity programme on metabolic syndrome markers and quality of life in Ghanaian adults with type 2 diabetes (T2DM). Design: Feasibility randomised controlled trial. Methods: Through random allocation, 90 adults with T2DM will be allocated to either the control group (CG) (n = 45) or the intervention group (IG) (n = 45). The IG will receive the physical activity programme in addition to their usual diabetes care; those in the CG will receive their usual diabetes care. Measurements will be performed at baseline and 12-week follow-up. The primary outcome is a change in metabolic syndrome markers in the IG compared to the CG. Secondary outcomes are: (a) a change in quality of life in the IG compared to the CG, (b) the feasibility of implementation. Results: Findings will inform the design of a future large-scale trial. Patient or Public Contribution: Patients with T2DM and their healthcare professionals contributed to this study protocol by participating in semi-structured interviews towards the design of the physical activity programme. Clinical Trial Registration Number: The trial is registered in the Australian and New Zealand Clinical Trial Registry (registration number: ACTRN12622000323729p).