Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes—the Sophia Step Study

International Journal of Behavioral Nutrition and Physical Activity

Kristina Larsson¹  Jenny Rossen¹  Unn-Britt Johansson²  Maria Hagströmer³  Kerstin Brismar⁴  Agneta Yngve⁵  Barbara Ainsworth⁶  Linda Åberg⁷ 

[1] Department of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden;Department of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden;Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden;Department of Health Promoting Science, Sophiahemmet University, Stockholm, Sweden;Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden;Academic Primary Care Center, Region Stockholm, Stockholm, Sweden;Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden;Rolf Luft Research Center for Diabetes and Endocrinology, Karolinska University Hospital, Stockholm, Sweden;Department of Nutrition, Dietetics and Food Studies, Uppsala University, Uppsala, Sweden;School of Health Sciences, Örebro University, Örebro, Sweden;School of Kinesiology, Shanghai University of Sport, Shanghai, China;College of Health Solutions, Arizona State University, Phoenix, AZ, USA;Smedby Primary Care Center, Kalmar, Sweden;

关键词: Activity tracker;    Behaviour;    Cardiometabolic risk factors;    HbA1c;    Pedometer;    Physical activity;    Step counter;   

DOI  :  10.1186/s12966-021-01193-w

来源: Springer

【 摘 要 】

BackgroundThis aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes.MethodsThe Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model.ResultsIn total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group.ConclusionThis 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes.Trial registrationClinicalTrials.gov, NCT02374788. Registered 2 March 2015—Retrospectively registered.

【 授权许可】

CC BY