Adaptation of a community-based type-2 diabetes mellitus remission intervention during COVID-19: empowering persons living with diabetes to take control

Abstract

Background: The Barbados Diabetes Remission Study-2 reported that a low-calorie diet for weight loss and diabetes remission implemented within the community and supported by trained community health advocates was both an acceptable implementation strategy and a clinically effective intervention. This study aimed to examine the adaptability of the face-to-face protocol into an online modality.

Methods: The Iterative Decision-making for Evaluation of Adaptations (IDEA) framework guides researchers in examining the necessity of the adaptation and the preservation of core intervention elements during the adaptation process. Adaptation outcomes were documented using the Framework for Reporting Adaptations and Modifications to Evidence-Based Implementation Strategies (FRAME-IS). Implementation outcome was determined by fidelity to core elements. Intervention effectiveness was determined from the analysis of clinical data.

Results: We decided that an adaptation was needed as COVID-19 control measures prohibited in-person interactions. The core elements-i.e. 12-week intervention duration, daily 840-kcal allowance, and weekly monitoring of weight and blood glucose-could be preserved during the adaptation process. Adaptations were made to the following: (1) the context in which data were collected-participants self-measured at home instead of following the original implementation strategy which involved being measured by community health advocates (CHA) at a community site; (2) the context in which data were entered-participants posted their measurements to a mobile application site which was accessible by CHAs. As with the original protocol, CHAs then entered the measurements into an online database; (3) the formulation of the low-calorie diet-participants substituted the liquid formulation for a solid meal plan of equivalent caloric content. There was non-inferiority in fidelity to attendance with the online format (97.5% visit rate), as compared to the face-to-face modality (95% visit rate). One participant deviated from the calorie allowances citing difficulty in estimating non-exact portion sizes and financial difficulty in procuring meals. Weight change ranged from - 14.3 to 0.4 kg over the 12-week period, and all group members achieved induction of diabetes remission as determined by a FBG of < 7mmol/l and an A1C of < 6.5%.

Conclusion: The results suggest that this adapted online protocol-which includes changes to both the implementation strategy and the evidence-based practice-is clinically effective whilst maintaining fidelity to key elements. Utilization of the IDEA and FRAME-IS adaptation frameworks add scientific rigour to the research.

Trial registration: ClinicalTrials.gov NCT03536377 . Registered on 24 May 2018.

Keywords: Adaptation; COVID-19; Community intervention; Fidelity; Low-calorie diet; Modification; Online intervention; Self-monitor; T2DM remission; Weight loss.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).