Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education (The BCC Study): Study Protocol for a Randomised, Parallel Open-label, Intervention Study Focusing on HbA1c and Glucose Variability in Patients with Type 2...

Overview

Journal BMJ Open

Specialty General Medicine

Date 2019 Nov 23

PMID 31753900

Citations 4

Authors

Bettina Ewers

Jens Meldgaard Bruun

Tina Vilsboll

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Comparing the Effectiveness of Different Dietary Educational Approaches for Carbohydrate Counting on Glycemic Control in Adults with Type 1 Diabetes: Findings from the DIET-CARB Study, a Randomized Controlled Trial.

Ewers B, Baek Blond M, Bruun J, Vilsboll T Nutrients. 2024; 16(21).

PMID: 39519579 PMC: 11547945. DOI: 10.3390/nu16213745.

Effects of basic carbohydrate counting versus standard dietary care for glycaemic control in type 2 diabetes (The BCC Study): a randomised, controlled trial.

Ewers B, Blond M, Bruun J, Vilsboll T Nutr Diabetes. 2024; 14(1):47.

PMID: 38937460 PMC: 11211433. DOI: 10.1038/s41387-024-00307-0.

The Impact of Using Carbohydrate Counting on Managing Diabetic Patients: A Review.

H Ibrahim S, Shahat E, Amer L, Aljohani A Cureus. 2023; 15(11):e48998.

PMID: 38111457 PMC: 10726644. DOI: 10.7759/cureus.48998.

The Association between Diabetes Education and Glucose Control in Diabetic Patients: Using the 2008 and 2013 Korea National Health and Nutrition Examination Survey.

Kim G, Park Y, Lim H Clin Nutr Res. 2020; 9(2):81-89.

PMID: 32395438 PMC: 7192670. DOI: 10.7762/cnr.2020.9.2.81.

References

Rothman R, Housam R, Weiss H, Davis D, Gregory R, Gebretsadik T . Patient understanding of food labels: the role of literacy and numeracy. Am J Prev Med. 2006; 31(5):391-8. DOI: 10.1016/j.amepre.2006.07.025. View

Tay J, Luscombe-Marsh N, Thompson C, Noakes M, Buckley J, Wittert G . Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial. Am J Clin Nutr. 2015; 102(4):780-90. DOI: 10.3945/ajcn.115.112581. View

Bell K, Barclay A, Petocz P, Colagiuri S, Brand-Miller J . Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2014; 2(2):133-40. DOI: 10.1016/S2213-8587(13)70144-X. View

Lowe J, Linjawi S, Mensch M, JAMES K, Attia J . Flexible eating and flexible insulin dosing in patients with diabetes: Results of an intensive self-management course. Diabetes Res Clin Pract. 2008; 80(3):439-43. DOI: 10.1016/j.diabres.2008.02.003. View

Bell K, Gray R, Munns D, Petocz P, Steil G, Howard G . Clinical Application of the Food Insulin Index for Mealtime Insulin Dosing in Adults with Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2016; 18(4):218-25. DOI: 10.1089/dia.2015.0254. View

Mann J, De Leeuw I, Hermansen K, Karamanos B, Karlstrom B, Katsilambros N . Evidence-based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis. 2005; 14(6):373-94. DOI: 10.1016/s0939-4753(04)80028-0. View

Evert A, Boucher J, Cypress M, Dunbar S, Franz M, Mayer-Davis E . Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2013; 36(11):3821-42. PMC: 3816916. DOI: 10.2337/dc13-2042. View

Davies M, DAlessio D, Fradkin J, Kernan W, Mathieu C, Mingrone G . Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018; 41(12):2669-2701. PMC: 6245208. DOI: 10.2337/dci18-0033. View

McGowan L, Caraher M, Raats M, Lavelle F, Hollywood L, McDowell D . Domestic cooking and food skills: A review. Crit Rev Food Sci Nutr. 2015; 57(11):2412-2431. DOI: 10.1080/10408398.2015.1072495. View

10.

Bowen M, Cavanaugh K, Wolff K, Davis D, Gregory R, Shintani A . The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education. Patient Educ Couns. 2016; 99(8):1368-76. PMC: 4931976. DOI: 10.1016/j.pec.2016.03.017. View

11.

Liang S, Yin H, Wei C, Xie L, He H, Liu X . Glucose variability for cardiovascular risk factors in type 2 diabetes: a meta-analysis. J Diabetes Metab Disord. 2017; 16:45. PMC: 5686902. DOI: 10.1186/s40200-017-0323-5. View

12.

Bowen M, Cavanaugh K, Wolff K, Davis D, Gregory B, Rothman R . Numeracy and dietary intake in patients with type 2 diabetes. Diabetes Educ. 2013; 39(2):240-7. PMC: 4127807. DOI: 10.1177/0145721713475841. View

13.

Fu S, Li L, Deng S, Zan L, Liu Z . Effectiveness of advanced carbohydrate counting in type 1 diabetes mellitus: a systematic review and meta-analysis. Sci Rep. 2016; 6:37067. PMC: 5107938. DOI: 10.1038/srep37067. View

14.

Toft U, Kristoffersen L, Ladelund S, Ovesen L, Lau C, Pisinger C . The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial. Int J Behav Nutr Phys Act. 2008; 5:59. PMC: 2607304. DOI: 10.1186/1479-5868-5-59. View

15.

Bergenstal R, Johnson M, Powers M, Wynne A, Vlajnic A, Hollander P . Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008; 31(7):1305-10. PMC: 2453649. DOI: 10.2337/dc07-2137. View

16.

Huizinga M, Elasy T, Wallston K, Cavanaugh K, Davis D, Gregory R . Development and validation of the Diabetes Numeracy Test (DNT). BMC Health Serv Res. 2008; 8:96. PMC: 2390531. DOI: 10.1186/1472-6963-8-96. View

17.

Sheard N, Clark N, Brand-Miller J, Franz M, Pi-Sunyer F, Mayer-Davis E . Dietary carbohydrate (amount and type) in the prevention and management of diabetes: a statement by the american diabetes association. Diabetes Care. 2004; 27(9):2266-71. DOI: 10.2337/diacare.27.9.2266. View

18.

Moher D, Hopewell S, Schulz K, Montori V, Gotzsche P, Devereaux P . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c869. PMC: 2844943. DOI: 10.1136/bmj.c869. View

19.

Williams G, McGregor H, Zeldman A, Freedman Z, Deci E . Testing a self-determination theory process model for promoting glycemic control through diabetes self-management. Health Psychol. 2004; 23(1):58-66. DOI: 10.1037/0278-6133.23.1.58. View

20.

Rothman R, DeWalt D, Malone R, Bryant B, Shintani A, Crigler B . Influence of patient literacy on the effectiveness of a primary care-based diabetes disease management program. JAMA. 2004; 292(14):1711-6. DOI: 10.1001/jama.292.14.1711. View