Implementation of a community-based low-calorie dietary intervention for the induction of type-2 diabetes and pre-diabetes remission: a feasibility study utilising a type 2 hybrid design.

Objectives: The aims of this feasibility study were to (1) examine the implementation of a community-based health advocate (CHA) training programme to develop the clinical skills needed to support a diabetes remission protocol based on a low-calorie diet (LCD) and (2) investigate if participant weight loss can be achieved and diabetes remission induced under these conditions.

Methods: This tripartite study followed a type 2 implementation-effectiveness design. Three faith-based organisations (FBOs) were purposively selected as study sites. Implementation outcomes were guided by the Consolidated Framework for Implementation Research. During the pre-implementation phase, site 'readiness' to facilitate the intervention was determined from a site visit and an interview with the FBOs' leadership. During the implementation phase, congregants could volunteer for the 10-week CHA training which included practical exercises in weight, glucose and blood pressure (BP) measurement, and a summative practical assessment. Acceptability and implementation effectiveness were assessed via survey. During the intervention phase, other congregants and community members with T2DM or pre-diabetes and overweight were invited to participate in the 12-week LCD. Anti-diabetic medication was discontinued on day 1 of the intervention. Clinical effectiveness was determined from the change in weight, fasting blood glucose (FBG) and BP which were monitored weekly at the FBO by the CHA. HbA1C was performed at weeks 1 and 12.

Results: The FBOs were found to be ready as determined by their adequate resources and engagement in health-related matters. Twenty-nine CHAs completed the training; all attained a passing grade at ≥1 clinical station, indicating implementation effectiveness. CHA feedback indicated that the programme structure was acceptable and provided sufficient access to intervention-related material. Thirty-one persons participated in the LCD (11 T2DM:20 pre-diabetes). Mean (95%CI) weight loss was 6.0 kg (3.7 to 8.2), 7.9 kg in males vs 5.7 kg in females; A1C (%) decreased from 6.6 to 6.1, with a greater reduction in those with T2DM when compared to pre-diabetes. FBG decreased from 6.4 to 6.0mmol/L. T2DM remission rates were 60% and 90% by A1C<6.5% and FBG<7mmol/L respectively. Pre-diabetes remission was 18% and 40% by A1C<5.7% and FBG<5.6 respectively.

Conclusion: Implementation of a community-based diabetes remission protocol is both feasible and clinically effective. Its sustainability is to be determined. Adaptability to other disorders or other settings should be investigated.

Trial Registration: NCT03536377 registered on 24 May 2018.