Toward integrated and sustainable prevention against diabetes in rural China: study rationale and protocol of eCROPS.

backgroundBeing an intermediate stage in the development of diabetes, pre-diabetics were estimated as high as 14% to 63% in China and one to three quarters of them will develop into diabetes within 10 years. It is well established that the risk of diabetes progression can be modified substantially and a whole range of proven guidelines, protocols and methodologies are available. Unfortunately, most proven interventions are seldom used in daily practice and this is especially true in resource poor rural China. This project aims at demonstrating that an evolutionary intervention package featuring low cost, integration with routine services, cultural sensitization and self-optimization, is effective and sustainable in preventing diabetes. METHODS/

designThis project utilizes a quasi cluster randomized controlled trial and a batched implementation strategy in which villages are recruited in 7 blocks within 7 consecutive years respectively. Block 0 involves 3 villages and provides an opportunity for piloting and refining primitive intervention methodologies and protocols. The following 6 blocks consist of 14 villages each and serve as intervention arm; while all the villages not yet started intervention form the control arm. For each block, measurement happens at baseline and every 12 months (for plasma glucose) or monthly (for body weight and blood pressure) after baseline. These arrangements enable documentation of up to 6 years of consecutive measures and detection of lower incidence of progression into diabetes, improved body max index and blood pressure, and increased service use and involvement in healthy dietary and physical activities among pre-diabetics receiving the experimental intervention compared to themselves at baseline or those in the delayed-intervention control condition. DISCUSSION: China has a long history of separating disease prevention and treatment systems and there is a clear need to leverages key success factors in a synergetic way toward integrated and sustainable diabetes prevention. This project is owned and managed by local health authorities and utilizes available resources. It introduces a package of long-term incentives, establishes ongoing mechanisms for continuous capacity building and quality improvement, and builds up an operational cycle for catalyzing similar efforts in the local prefecture even throughout rural China.

trial registrationCurrent Controlled Trials: ISRCTN66772711.