Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT02374788
• Recruitment Status: Completed
• First Posted: March 2, 2015
• Last Update Posted: March 10, 2020
• Sponsor: Sophiahemmet University
• Collaborators: Karolinska Institutet; Uppsala University; Arizona State University
• Information provided by (Responsible Party): Unn-Britt Johansson, Sophiahemmet University

Study Description

Brief Summary:

The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.

The hypothesis is that both levels of interventions have effect on HbA1c with the more intense Group intervention having superior effects.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes; Prediabetes	Behavioral: Pedometer intervention; Behavioral: Group meetings; Behavioral: Individual consultations	Not Applicable

Detailed Description:

Regularly physical activity may decrease the risk for type 2 diabetes, cardiovascular diseases, overweight and premature deaths. Despite the evidence that physical activity is beneficial to health,it is often ignored and underused aspect in diabetes care. The aim of the study is to investigate the effects of two levels of primary care physical activity interventions on metabolic control and cardiovascular risk factors, compared to usual care in patients with pre- and type 2 diabetes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Health Promotion in the Primary Care Setting- an Evaluation of the Sophia Step Study- a Structured Behaviour Change Program Focusing on Physical Activity in Persons With Pre- and Type 2 Diabetes
• Study Start Date: November 2013
• Actual Primary Completion Date: February 17, 2020
• Actual Study Completion Date: February 17, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Pedometer intervention; Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.; Behavioral: Group meetings; Participants receive 12 group meetings over two years' time.; Behavioral: 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.
Experimental: Group B; Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years.	Behavioral: Pedometer intervention; Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. HbA1c (mmol/mol) [ Time Frame: up to month 24. ]
   Haemoglobin A1c

Secondary Outcome Measures :

1. fasting plasma glucose (mmol/L) [ Time Frame: week 0, 12, 24, and month 9, 12, 18 and 24. ]
   Determined by a glucose oxidase method
2. Physical activity level (counts/min) [ Time Frame: week 0 and month 6, 12, 18, 24 ]
   Actigraph accelerometer GT1M
3. Steps/day [ Time Frame: week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24. ]
   Actigraph accelerometer GT1M
4. fasting-Insulin (mU/l) [ Time Frame: week 0, 12, 24, and month 12 and 24. ]
   Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia & Upjohn, Stockholm.
5. LDL (mmol/L) [ Time Frame: week 0, 12, 24, and month 12 and 24. ]
   LDL is determined by using a homogeneous method (lowdensity lipoprotein)
6. Total cholesterol (mmol/L) [ Time Frame: week 0, 12, 24, and month 12 and 24. ]
   total Cholesterol is determined by using enzymatic method
7. IGF BP1 (μg/L) [ Time Frame: week 0, 12, 24, and month 12 and 24. ]
   insulin-like growth factor binding protein 1
8. Free fatty acids (mmol(L ) [ Time Frame: week 0, 12, 24, and month 12 and 24. ]
   Samples are saved for later free fatty acid analyses.
9. Triglycerides (mmol/L) [ Time Frame: week 0, 12, 24, and month 12, 18 and 24. ]
   Triglycerides is determined by using enzymatic method (Triglycerides)
10. HDL (mmol/L) [ Time Frame: week 0, 12, 24, and month 12, 18 and 24. ]
    HDL is determined by using a homogeneous method (lowdensity lipoprotein)(High-density lipoprotein)
11. ApoB (g/l) [ Time Frame: week 0, 24 and month 24. ]
    Apolipoprotein B is determined by using turbimetric method
12. ApoA1 (g/l) [ Time Frame: week 0, 24 and month 24. ]
    ApolipoproteinA1 is determined by using turbimetric method
13. C-peptide (pmol/l) [ Time Frame: week 0, 12, 24, and month 12 and 24. ]
    C-peptid are determined by using immunometric method using two monoclonal antibodies and detection with electrochemiluminiscense using a Modular E system (Beckman Coulter, Inc.).
14. BMI (kg/m2) [ Time Frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24. ]
    Body mass index
15. Weight (kg) [ Time Frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24. ]
    Tanita digital scale (Model TBF- 300A, Arlington Heights, IL). Weight is measured with light clothes, no shoes to the nearest 0.1 kg.
16. % Body Fat [ Time Frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24. ]
    % Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL).
17. Waist circumference (cm) [ Time Frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24. ]
    Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus.
18. Sagittal Abdominal Diameter (cm) [ Time Frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24. ]
    Sagittal abdominal diameter is measured with the subject in a supine position with the knees expanded at the level of the umbilicus using a Holtain-Kahn abdominal caliper (Holtain, Ltd., Crosswell, Crymych; Dyfed, UK).
19. Resting blood pressure (mmHg) [ Time Frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24. ]
    diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort.
20. Muscle strength [ Time Frame: week 0, 12, 24, and month 9, 12, 18 and 24. ]
    measured by hand-held dynamometry. Hand grip strength is measured in kilograms using the hand-held Saehan Hydraulic Hand Dynamometer, model SH5001 (former Jamar) (Saehan Corporation, Masan, South Korea).
21. Change in Smoking and snuffing habits [ Time Frame: Evaluation is conducted at baseline and at 24 months after completion of the intervention period ]
    Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose

Other Outcome Measures:

1. Change in Dietary habits [ Time Frame: Evaluation is conducted at baseline and at week 8, 12, 24 and month 12 and 24 after completion of the intervention period ]
   Change in Dietary habits is measured by a set of questions developed and validated by The Swedish National Food Agency.
2. Change in Alcohol habits [ Time Frame: Evaluation is conducted at baseline and at week 24 and month 12 and 24 after completion of the intervention period ]
   Change in Alcohol habits is measured by two questions from AUDIT-The alcohol Use disorders
3. Change in Stress and working condition [ Time Frame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period ]
   Change in Stress and working condition is measured by four questions
4. EuroQol (EQ-5D) [ Time Frame: week 0, 12, 24 and month 12 and 24 ]
   measured by EQ-5D assess components of health related QoL (HRQoL). EQ-5D includes measures related to mobility, hygiene, daily activities, pain/ discomfort and anxiety/depression.
5. Sleep [ Time Frame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period ]
   Sleep is measured by two questions. One question on difficulties falling asleep and one question on sleep quality.
6. Self reported physical activity [ Time Frame: week 0, 12, 24 and month 12 and 24 ]
   International Physical Activity Questionnaire (IPAQ) self-reported 7-item questionnaire to assess physical activity.
7. Self-efficacy for exercise [ Time Frame: week 0, 12, 24 and month 12 and 24 ]
   The questionnaire Self-efficacy for exercise is a 5 item questionnaire and assess one´s confidence to continue exercising in different situations.
8. Physical Activity Social Support (PASS) [ Time Frame: week 0, 12, 24 and month 12 and 24 ]
   Physical Activity Social Support (PASS) for exercise 6 items.
9. Change in Neighborhood Environment [ Time Frame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period ]
   Change in Neighborhood Environment is measured by 17 questions about Walking Environment, Availability of healthy Foods, Safety and Social cohesion
10. Change in Perceived Stress Scale (PSS) [ Time Frame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period ]
    Change in Perceived Stress is measured by the Perceived Stress Scale (PSS) which is a 14- items questionnaire.
11. Change in diabetes distress (PAID-20) [ Time Frame: Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period ]
    Diabetes distress is measured by The Problem Areas in Diabetes questionnaire (Swe-PAID-20): This is a 20 items questionnaire
12. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: week 0, 12, 24 and month 12 and 24 ]
    HADS is a 14 item questionnaire and consists of two subscales depression and anxiety, with seven items each.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Ability to communicate in Swedish Age 40-80 years Type 2 diabetes: Diagnosed type 2 diabetes with a duration of >=1 year Pre-diabetes: HbA1c >39-<47, Fasting plasma glucose >5.6 mmol/l

Exclusion Criteria:

• Myocardial infarction in the past 6 months
• 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.

Contacts and Locations

Locations

Sweden

Sophiahemmet University

Stockholm, Sweden, 114 86

Sponsors and Collaborators

Sophiahemmet University

Karolinska Institutet

Uppsala University

Arizona State University

Investigators

• Principal Investigator: Unn-Britt Johansson, Professor; Sophiahemmet University

More Information

Additional Information:

Study protocol 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Unn-Britt Johansson, Sophiahemmet University
• ClinicalTrials.gov Identifier: NCT02374788
• Other Study ID Numbers: SophiahemmetU
• First Posted: March 2, 2015
• Last Update Posted: March 10, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases