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 diabetes

Bettina Ewers, Jens Meldgaard Bruun, Tina Vilsbøll, Bettina Ewers, Jens Meldgaard Bruun, Tina Vilsbøll

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.

Keywords: basic carbohydrate counting; carbohydrate awareness; nutrition & dietetics; nutrition education; randomized controlled trial; type 2 diabetes.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study design. BCC, basic carbohydrate counting.
Figure 2
Figure 2
Schematic diagram of the intervention. BCC, basic carbohydrate counting; BP, blood pressure; BW, body weight; CGM, continuous glucose monitoring; DXA, dual-energy X-ray absorptiometry; V, visit; WHC, waist-hip circumference.
Figure 3
Figure 3
Study flow diagram. The planned flow of participants through the stages of the study. BCC, basic carbohydrate counting.

References

    1. American Diabetes Association 4. Lifestyle Management: Standards of Medical Care in Diabetes-2018. Diabetes Care 2018;41:S38–50. 10.2337/dc18-S004
    1. Davies MJ, D'Alessio DA, Fradkin J, et al. . 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;41:2669–701. 10.2337/dci18-0033
    1. Evert AB, Dennison M, Gardner CD, et al. . Nutrition therapy for adults with diabetes or prediabetes: a consensus report. Diabetes Care 2019;42:731–54. 10.2337/dci19-0014
    1. Guidelines for type 2-diabetes En fælles behandlingsvejledning Med enslydende kliniske behandlingsmål. revision. Dansk Endokrinologisk Selskab (des), Dansk Selskab for Almen Medicin (DSAM) OG. Copenhagen: Institut for Rationel Farmakoterapi (IRF), 2014.
    1. Evert AB, Boucher JL, Cypress M, et al. . Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care 2013;36:3821–42. 10.2337/dc13-2042
    1. Sheard NF, Clark NG, Brand-Miller JC, et al. . Dietary carbohydrate (amount and type) in the prevention and management of diabetes: a statement by the American diabetes association. Diabetes Care 2004;27:2266–71. 10.2337/diacare.27.9.2266
    1. American Diabetes Association 4. Lifestyle management. Diabetes Care 2017;40:S33–43. 10.2337/dc17-S007
    1. Mann JI, De Leeuw I, Hermansen K, et al. . Evidence-based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis 2004;14:373–94. 10.1016/S0939-4753(04)80028-0
    1. Daly A, Bolderman K, Franz M. Basic carbohydrate counting. Alexandria VA and Chicago: American Diabetes Association and American Dietetic Association, 2003.
    1. Daly A, Bolderman K, Franz M. Advanced carbohydrate counting. Alexandria VA and Chicago: American Diabetes Association and American Dietetic Association, 2003.
    1. Gillespie SJ, Kulkarni KD, Daly AE. Using carbohydrate counting in diabetes clinical practice. J Am Diet Assoc 1998;98:897–905. 10.1016/S0002-8223(98)00206-5
    1. Bell KJ, Barclay AW, Petocz P, et al. . Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol 2014;2:133–40. 10.1016/S2213-8587(13)70144-X
    1. Fu S, Li L, Deng S, et al. . Effectiveness of advanced carbohydrate counting in type 1 diabetes mellitus: a systematic review and meta-analysis. Sci Rep 2016;6:37067 10.1038/srep37067
    1. Schmidt S, Schelde B, Nørgaard K. Effects of advanced carbohydrate counting in patients with type 1 diabetes: a systematic review. Diabet Med 2014;31:886–96. 10.1111/dme.12446
    1. Bergenstal RM, Johnson M, Powers MA, et al. . Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care 2008;31:1305–10. 10.2337/dc07-2137
    1. Lowe J, Linjawi S, Mensch M, et al. . Flexible eating and flexible insulin dosing in patients with diabetes: results of an intensive self-management course. Diabetes Res Clin Pract 2008;80:439–43. 10.1016/j.diabres.2008.02.003
    1. Bowen ME, Cavanaugh KL, Wolff K, et al. . 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;99:1368–76. 10.1016/j.pec.2016.03.017
    1. Bowen ME, Cavanaugh KL, Wolff K, et al. . Numeracy and dietary intake in patients with type 2 diabetes. Diabetes Educ 2013;39:240–7. 10.1177/0145721713475841
    1. Huizinga MM, Beech BM, Cavanaugh KL, et al. . Low numeracy skills are associated with higher BMI. Obesity 2008;16:1966–8. 10.1038/oby.2008.294
    1. Huizinga MM, Carlisle AJ, Cavanaugh KL, et al. . Literacy, numeracy, and portion-size estimation skills. Am J Prev Med 2009;36:324–8. 10.1016/j.amepre.2008.11.012
    1. Rothman RL, DeWalt DA, Malone R, et al. . Influence of patient literacy on the effectiveness of a primary care-based diabetes disease management program. JAMA 2004;292:1711–6. 10.1001/jama.292.14.1711
    1. Rothman RL, Housam R, Weiss H, et al. . Patient understanding of food labels: the role of literacy and numeracy. Am J Prev Med 2006;31:391–8.
    1. Bishop FK, Maahs DM, Spiegel G, et al. . The carbohydrate counting in adolescents with type 1 diabetes (CCAT) study. Diabetes Spectrum 2009;22:56–62. 10.2337/diaspect.22.1.56
    1. Mehta SN, Quinn N, Volkening LK, et al. . Impact of carbohydrate counting on glycemic control in children with type 1 diabetes. Diabetes Care 2009;32:1014–6. 10.2337/dc08-2068
    1. Smart CE, Ross K, Edge JA, et al. . Can children with type 1 diabetes and their caregivers estimate the carbohydrate content of meals and snacks? Diabet Med 2010;27:348–53. 10.1111/j.1464-5491.2010.02945.x
    1. McGowan L, Caraher M, Raats M, et al. . Domestic cooking and food skills: a review. Crit Rev Food Sci Nutr 2017;57:2412–31. 10.1080/10408398.2015.1072495
    1. Toft U, Kristoffersen L, Ladelund S, et al. . 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 10.1186/1479-5868-5-59
    1. Sundhedsstyrelsen National klinisk retningslinje for udvalgte sundhedsfaglige indsatser ved rehabilitering TIL patienter Med type 2 diabetes. Copenhagen: Sundhedsstyrelsen (Danish Health & Medicines Authority, 2015.
    1. Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care 1998;21:1644–51. 10.2337/diacare.21.10.1644
    1. Liang S, Yin H, Wei C, et al. . Glucose variability for cardiovascular risk factors in type 2 diabetes: a meta-analysis. J Diabetes Metab Disord 2017;16 10.1186/s40200-017-0323-5
    1. Su G, Mi S, Tao H, et al. . Association of glycemic variability and the presence and severity of coronary artery disease in patients with type 2 diabetes. Cardiovasc Diabetol 2011;10:19 10.1186/1475-2840-10-19
    1. Danne T, Nimri R, Battelino T, et al. . International consensus on use of continuous glucose monitoring. Diabetes Care 2017;40:1631–40. 10.2337/dc17-1600
    1. Sato E, Suzukamo Y, Miyashita M, et al. . Development of a diabetes diet-related quality-of-life scale. Diabetes Care 2004;27:1271–5. 10.2337/diacare.27.6.1271
    1. Williams GC, McGregor HA, Zeldman A, et al. . Testing a self-determination theory process model for promoting glycemic control through diabetes self-management. Health Psychol 2004;23:58–66. 10.1037/0278-6133.23.1.58
    1. Huizinga MM, Elasy TA, Wallston KA, et al. . Development and validation of the diabetes Numeracy test (DNT). BMC Health Serv Res 2008;8:96 10.1186/1472-6963-8-96
    1. Lee PH, Macfarlane DJ, Lam TH, et al. . Validity of the International physical activity questionnaire short form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act 2011;8 10.1186/1479-5868-8-115
    1. Bell KJ, Gray R, Munns D, et al. . 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;18:218–25. 10.1089/dia.2015.0254
    1. Tay J, Luscombe-Marsh ND, Thompson CH, et al. . Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial. Am J Clin Nutr 2015;102:780–90. 10.3945/ajcn.115.112581
    1. Moher D, Hopewell S, Schulz KF, et al. . Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869 10.1136/bmj.c869

Source: PubMed

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