Background: The Barbados Diabetes Remission Study-2 reported that a community-based low-calorie diet (LCD) for weight loss and diabetes remission was both an acceptable implementation strategy and a clinically effective intervention. This study aimed to examine the adaptability of the face-to-face BDRS-2 protocol into an online modality.
Methods: The Iterative Decision‐making for Evaluation of Adaptations framework questions the necessity of the adaptation and the preservation of core elements of the intervention during the adaptation process – these elements were identified as the 12-week intervention duration, weekly monitoring of participants for change in weight and fasting blood glucose and daily 840kcal allowance. The adaptation outcomes were documented using the framework for reporting adaptations and modifications to evidence-based interventions. Implementation effectiveness was determined by fidelity to core intervention elements. Intervention effectiveness was determined from the analysis of clinical data.
Results: We decided that an adaptation was needed as the COVID-19 measures to control transmission prohibited in-person interactions, and that key elements of the intervention could be preserved during the adaptation process.
Adaptations were made to the following: (1) The context in which the data was collected: participants self-measured at home instead of being measured by community health advocates (CHA) at a community site. (2) The context in which the data was entered: participants first posted their measurements to a mobile application site which was accessible by the CHAs. As with the original protocol, CHAs then entered the measurements into an online database. (3) The formulation of the LCD: participants substituted the liquid formulation for a solid meal plan of equivalent caloric content.
There was increased fidelity to the attendance schedule with the online format (1 incomplete entry out of 45 entries), as compared to the face-to-face modality (1 absence out of 20 visits). Regarding the solid meal plan, 1 participant logged difficultly averaging non-exact potion sizes.
Weight change ranged from -14.3kgs to 0.4kgs over the 12-week period and all group members achieved induction of diabetes remission.
Conclusion: Larger studies are needed to confirm that this adapted online protocol is both acceptable and clinically effective while maintaining fidelity to key elements of the original protocol.
Trial Registration: NCT03536377 registered 24th May 2018 at https://clinicaltrials.gov/ct2/show/NCT03536377