Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes
NCT ID: NCT02374788
Last Updated: 2020-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
188 participants
INTERVENTIONAL
2013-11-30
2020-02-17
Brief Summary
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The hypothesis is that both levels of interventions have effect on HbA1c with the more intense Group intervention having superior effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Participants in the intensive intervention group (A) receive a pedometer intervention and 12 group meetings over two years' time, with the majority of meetings being held in the first 6 months. The group meetings constitutes of a 30 min walk and 60 min group consulting based on techniques for behaviour change using an interactive program with positive feed-back following their steps on a website. One occasion is taking place at a gym with instruction for a home-based strength training program. Participants receive 10 individual consultations with a diabetes specialist nurse.
Pedometer intervention
Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
Group meetings
Participants receive 12 group meetings over two years' time.
Individual consultations
Participants receive 10 individual meetings with a diabetes specialist nurse. Physical activity on prescription is used to set individual goals and to highlight the importance of physical activity.
Group B
Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years.
Pedometer intervention
Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
Group C
The control group (C) receive diabetes care as usual except for the extra measurements included in the study. Diabetes care as usual is meeting a diabetes specialist nurse and a general practitioner once a year receiving lifestyle advice and physical activity on prescription.
No interventions assigned to this group
Interventions
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Pedometer intervention
Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
Group meetings
Participants receive 12 group meetings over two years' time.
Individual consultations
Participants receive 10 individual meetings with a diabetes specialist nurse. Physical activity on prescription is used to set individual goals and to highlight the importance of physical activity.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* serum creatinine \>140
* diabetic ulcer or risk for ulcer
* prescribed insulin in past 6 months
* additional disease prohibiting physical activity
* have experienced repeated hypoglycaemia or severe hypoglycaemia in past 12 months
* classified in very hard-intensity activity according to Stanford Brief Activity Survey
* having no access to internet.
40 Years
80 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Uppsala University
OTHER
Arizona State University
OTHER
Sophiahemmet University
OTHER
Responsible Party
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Unn-Britt Johansson
Unn-Britt Johansson
Principal Investigators
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Unn-Britt Johansson, Professor
Role: PRINCIPAL_INVESTIGATOR
Sophiahemmet University
Locations
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Sophiahemmet University
Stockholm, , Sweden
Countries
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References
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Rossen J, Yngve A, Hagstromer M, Brismar K, Ainsworth BE, Iskull C, Moller P, Johansson UB. Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT. BMC Public Health. 2015 Jul 12;15:647. doi: 10.1186/s12889-015-1941-9.
Larsson K, Von Rosen P, Rossen J, Johansson UB, Hagstromer M. Relative time in physical activity and sedentary behaviour across a 2-year pedometer-based intervention in people with prediabetes or type 2 diabetes: a secondary analysis of a randomised controlled trial. J Act Sedentary Sleep Behav. 2023 Jun 1;2(1):10. doi: 10.1186/s44167-023-00020-w.
Larsson K, Rossen J, Norman A, Johansson UB, Hagstromer M. Predictors associated with an increase in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention. BMC Public Health. 2024 May 11;24(1):1290. doi: 10.1186/s12889-024-18766-6.
Rossen J, Larsson K, Hagstromer M, Yngve A, Brismar K, Ainsworth B, Aberg L, Johansson UB. 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. Int J Behav Nutr Phys Act. 2021 Sep 8;18(1):121. doi: 10.1186/s12966-021-01193-w.
Rossen J, Hagstromer M, Yngve A, Brismar K, Ainsworth B, Johansson UB. Process evaluation of the Sophia Step Study- a primary care based three-armed randomized controlled trial using self-monitoring of steps with and without counseling in prediabetes and type 2 diabetes. BMC Public Health. 2021 Jun 22;21(1):1191. doi: 10.1186/s12889-021-11222-9.
Rossen J, Von Rosen P, Johansson UB, Brismar K, Hagstromer M. Associations of physical activity and sedentary behavior with cardiometabolic biomarkers in prediabetes and type 2 diabetes: a compositional data analysis. Phys Sportsmed. 2020 May;48(2):222-228. doi: 10.1080/00913847.2019.1684811. Epub 2019 Nov 12.
Related Links
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Other Identifiers
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SophiahemmetU
Identifier Type: -
Identifier Source: org_study_id
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