A study protocol for a cluster randomized controlled trial to test the applicability of the South African diabetes prevention program in the Eastern Cape Province of South Africa

Abstract

Abstract Background Convincing evidence supports the effectiveness of lifestyle interventions in preventing the occurrence of diabetes in high-income countries, however little is known about appropriate interventions for use in African countries, where there are higher relative increases in diabetes prevalence. The South African Diabetes Prevention Programme (SA-DPP) was initiated with the aim of preventing or delaying the occurrence of diabetes among South Africans (SAs), through interventions, targeting lifestyle changes related to diet and physical activity. The purpose of the current project is to implement and evaluate the suitability and applicability of the SA-DPP developed and tailored in urban populations in the Western Cape Province, in peri-urban populations in the Eastern Cape Province of SA. Methods The SA-DPP, which is an cluster randomized control trial, will be implemented in adults aged 30–65 years residing in the OR Tambo district, Eastern Cape, SA. Participants will be recruited using self-selected sampling techniques and 24 clusters across peri-urban communities will be randomly allocated to participate in the lifestyle intervention, facilitated by non-professional health workers (NPHW). The diabetes risk screening will follow a two-staged approach, including the community-based screening, using the African diabetes risk score (ADRS), followed by a clinic-based risk status assessment by an oral glucose tolerance test (OGTT) to exclude unknown diabetes. The lifestyle-change objectives of the current programme relate to, 1) < 30% of total energy intake from fat; 2) < 10% of total energy intake from saturated fat; 3) > 15 g of fibre/1000 kcal; 4) > 4 h/week moderate level of physical activity; and 5) > 2% body mass index (BMI) reduction. Discussion The SA-DPP could represent a successful model for the prevention of diabetes and potentially other lifestyle-related diseases in SA and other countries in the region that are confronted with similar challenges. Trial registration PACTR202205591282906.