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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes, Prediabetes

Intervention / Treatment
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* Behavioral: Pedometer intervention
* Behavioral: Group meetings
* Behavioral: Individual consultations


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.<br>Behavioral: Group meetings<br>* Participants receive 12 group meetings over two years' time.<br>Behavioral: Individual consultations<br>* 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.<br>|
| Experimental: Group B<br>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<br>* Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.<br>|
| No Intervention: Group C<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (mmol/mol) | Haemoglobin A1c | up to month 24. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose (mmol/L) | Determined by a glucose oxidase method | week 0, 12, 24, and month 9, 12, 18 and 24. | 
| Physical activity level (counts/min) | Actigraph accelerometer GT1M | week 0 and month 6, 12, 18, 24 | 
| Steps/day | Actigraph accelerometer GT1M | week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24. | 
| fasting-Insulin (mU/l) | Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia & Upjohn, Stockholm. | week 0, 12, 24, and month 12 and 24. | 
| LDL (mmol/L) | LDL is determined by using a homogeneous method (lowdensity lipoprotein) | week 0, 12, 24, and month 12 and 24. | 
| Total cholesterol (mmol/L) | total Cholesterol is determined by using enzymatic method | week 0, 12, 24, and month 12 and 24. | 
| IGF BP1 (μg/L) | insulin-like growth factor binding protein 1 | week 0, 12, 24, and month 12 and 24. | 
| Free fatty acids (mmol(L ) | Samples are saved for later free fatty acid analyses. | week 0, 12, 24, and month 12 and 24. | 
| Triglycerides (mmol/L) | Triglycerides is determined by using enzymatic method (Triglycerides) | week 0, 12, 24, and month 12, 18 and 24. | 
| HDL (mmol/L) | HDL is determined by using a homogeneous method (lowdensity lipoprotein)(High-density lipoprotein) | week 0, 12, 24, and month 12, 18 and 24. | 
| ApoB (g/l) | Apolipoprotein B is determined by using turbimetric method | week 0, 24 and month 24. | 
| ApoA1 (g/l) | ApolipoproteinA1 is determined by using turbimetric method | week 0, 24 and month 24. | 
| C-peptide (pmol/l) | C-peptid are determined by using immunometric method using two monoclonal antibodies and detection with electrochemiluminiscense using a Modular E system (Beckman Coulter, Inc.). | week 0, 12, 24, and month 12 and 24. | 
| BMI (kg/m2) | Body mass index | week 0,8, 12,16, 24, and month 9, 12, 18 and 24. | 
| Weight (kg) | Tanita digital scale (Model TBF- 300A, Arlington Heights, IL). Weight is measured with light clothes, no shoes to the nearest 0.1 kg. | week 0,8, 12,16, 24, and month 9, 12, 18 and 24. | 
| % Body Fat | % Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL). | week 0,8, 12,16, 24, and month 9, 12, 18 and 24. | 
| Waist circumference (cm) | Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus. | week 0,8, 12,16, 24, and month 9, 12, 18 and 24. | 
| Sagittal Abdominal Diameter (cm) | 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). | week 0,8, 12,16, 24, and month 9, 12, 18 and 24. | 
| Resting blood pressure (mmHg) | diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort. | week 0,8, 12,16, 24, and month 9, 12, 18 and 24. | 
| Muscle strength | 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). | week 0, 12, 24, and month 9, 12, 18 and 24. | 
| Change in Smoking and snuffing habits | Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose | Evaluation is conducted at baseline and at 24 months after completion of the intervention period |