Introduction Recommendations on energy intake are key in body weight management to improve glycaemic control in people with type 2 diabetes (T2D). International clinical guidelines recommend a variety of eating patterns to promote energy restriction as the primary dietetic approach to body weight control in managing T2D. In addition, individualised guidance on self-monitoring carbohydrate intake to optimise meal timing and food choices (eg, basic carbohydrate counting (BCC)) is recommended to achieve glycaemic control. However, the evidence for this approach in T2D is limited. The objective of this study was to compare the effect of an educational programme in BCC as add-on to the usual dietary care on glycaemic control in people with T2D.
Methods and analyses The study is designed as a randomised, controlled trial with a parallel-group design. The study duration is 12 months with data collection at baseline, and after 6 and 12 months. We plan to include 226 adults with T2D. Participants will be randomised to one of two interventions: (1) BCC as add-on to usual dietary care or (2) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline and after 6-month intervention between and within study groups. Further outcome measures include changes in time in range, body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in diet and diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers.
Ethics and dissemination The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations.
Trial registration number NCT03623139.
- nutrition & dietetics
- carbohydrate awareness
- basic carbohydrate counting
- type 2 diabetes
- nutrition education
- randomized controlled trial
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Contributors BE conceived the original idea for this trial, planned the study design, performed the sample size calculations and wrote the first draft of the protocol manuscript. TV and JMB provided valuable input regarding trial design, planning and analytical considerations, and edited the first draft of the protocol manuscript. All authors approved the final version of the clinical trial protocol. BE is the principle investigator and is responsible for correspondence with all authorities regarding the study and is responsible for the data collection (recruitment, screening and clinical study examinations), overall monitoring the trial and for conducting the statistical analyses. TV and JMB are supervisors and coinvestigators of this trial. Should any safety concerns arise during the conduct of the study, these will be brought to the attention of TV and JMB by BE and will be carefully reviewed.
Funding This work was supported by The Beckett Foundation (grant number 17-2-0957), the Axel Muusfeldts Foundation (grant no 2017-856) and the Novo Nordisk Foundation (no assigned grant number) as part of a supplementary treatment initiative at SDCC in 2018-2020.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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