title: Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT.
abstract: BACKGROUND
  Physical activity prevents or delays progression of impaired glucose tolerance in high-risk individuals. Physical activity promotion should serve as a basis in diabetes care. It is necessary to develop and evaluate health-promoting methods that are feasible as well as cost-effective within diabetes care. The aim of Sophia Step Study is to evaluate the impact of a multi-component and a single component physical activity intervention aiming at improving HbA1c (primary outcome) and other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes.
  
  
  METHODS
  Sophia Step Study is a randomized controlled trial and participants are randomly assigned to either a multi-component intervention group (A), a pedometer group (B) or a control group (C). In total, 310 patients will be included and followed for 24 months. Group A participants are offered pedometers and a website to register steps, physical activity on prescription with yearly follow-ups, motivational interviewing (10 occasions) and group consultations (including walks, 12 occasions). Group B participants are offered pedometers and a website to register steps. Group C are offered usual care. The theoretical framework underpinning the interventions is the Health Belief Model, the Stages of Change Model, and the Social Cognitive Theory. Both the multi-component intervention (group A) and the pedometer intervention (group B) are using several techniques for behavior change such as self-monitoring, goal setting, feedback and relapse prevention. Measurements are made at week 0, 8, 12, 16, month 6, 9, 12, 18 and 24, including metabolic and cardiovascular biomarkers (HbA1c as primary health outcome), accelerometry and daily steps. Furthermore, questionnaires were used to evaluate dietary intake, physical activity, perceived ability to perform physical activity, perceived support for being active, quality of life, anxiety, depression, well-being, perceived treatment, perceived stress and diabetes self- efficacy.
  
  
  CONCLUSIONS
  This study will show if a multi-component intervention using pedometers with group- and individual consultations is more effective than a single- component intervention using pedometers alone, in increasing physical activity and improving HbA1c, other metabolic and cardiovascular risk factors, physical activity levels and overall health in patients with pre- and type 2 diabetes.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02374788 . Registered 28 January 2015.
authors.affiliation: Sophiahemmet University, Stockholm, Sweden. jenny.rossen@shh.se.|Department of Clinical Sciences and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden. jenny.rossen@shh.se.
authors.forename: Jenny
authors.initials: J
authors.lastname: Rossen
authors.affiliation: Sophiahemmet University, Stockholm, Sweden. agneta.yngve@oru.se.|School of Hospitality, Culinary Arts and Meal Sciences, Örebro University, Örebro, Sweden. agneta.yngve@oru.se.
authors.forename: Agneta
authors.initials: A
authors.lastname: Yngve
authors.affiliation: Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, and Department of Physical Therapy, Karolinska University Hospital, Stockholm, Sweden. maria.hagstromer@ki.se.
authors.forename: Maria
authors.initials: M
authors.lastname: Hagströmer
authors.affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet, and Rolf Luft Research Center for Diabetes and Endocrinology, Karolinska University Hospital, Stockholm, Sweden. kerstin.brismar@ki.se.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Brismar
authors.affiliation: School of Nutrition and Health Promotion, Arizona State University, Phoenix, AZ, USA. Barbara.Ainsworth@asu.edu.
authors.forename: Barbara E
authors.initials: BE
authors.lastname: Ainsworth
authors.affiliation: Sophiahemmet Hospital, Stockholm, Sweden. christina.iskull@sophiahemmet.se.
authors.forename: Christina
authors.initials: C
authors.lastname: Iskull
authors.affiliation: Sophiahemmet Hospital, Stockholm, Sweden. peter.moller@hlamottagningen.se.
authors.forename: Peter
authors.initials: P
authors.lastname: Möller
authors.affiliation: Sophiahemmet University, Stockholm, Sweden. unn-britt.johansson@shh.se.|Department of Clinical Sciences and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden. unn-britt.johansson@shh.se.
authors.forename: Unn-Britt
authors.initials: UB
authors.lastname: Johansson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology / Q000534:rehabilitation*; D015444:Exercise; D005260:Female; D005500:Follow-Up Studies; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062405:Motivational Interviewing; D011236:Prediabetic State / Q000523:psychology / Q000534:rehabilitation*; D011320:Primary Health Care / Q000379:methods*; D011795:Surveys and Questionnaires; D016138:Walking / Q000523:psychology