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

Sophiahemmet University188 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

188

Conditions

Type 2 Diabetes Prediabetes

Interventions

Pedometer interventionBEHAVIORAL

Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.

Group meetingsBEHAVIORAL

Participants receive 12 group meetings over two years' time.

Individual consultationsBEHAVIORAL

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

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sophiahemmet University

Stockholm, Sweden

Outcomes

Primary Outcomes

HbA1c (mmol/mol)

Haemoglobin A1c

Time frame: up to month 24.

Secondary Outcomes

fasting plasma glucose (mmol/L)

Determined by a glucose oxidase method

Time frame: week 0, 12, 24, and month 9, 12, 18 and 24.

Physical activity level (counts/min)

Actigraph accelerometer GT1M

Time frame: week 0 and month 6, 12, 18, 24

Steps/day

Actigraph accelerometer GT1M

Time frame: 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.

Time frame: week 0, 12, 24, and month 12 and 24.

LDL (mmol/L)

LDL is determined by using a homogeneous method (lowdensity lipoprotein)

Time frame: week 0, 12, 24, and month 12 and 24.

Total cholesterol (mmol/L)

total Cholesterol is determined by using enzymatic method

Time frame: week 0, 12, 24, and month 12 and 24.

IGF BP1 (μg/L)

insulin-like growth factor binding protein 1

Time frame: week 0, 12, 24, and month 12 and 24.

Free fatty acids (mmol(L )

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Samples are saved for later free fatty acid analyses.

Time frame: week 0, 12, 24, and month 12 and 24.

Triglycerides (mmol/L)

Triglycerides is determined by using enzymatic method (Triglycerides)

Time frame: 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)

Time frame: week 0, 12, 24, and month 12, 18 and 24.

ApoB (g/l)

Apolipoprotein B is determined by using turbimetric method

Time frame: week 0, 24 and month 24.

ApoA1 (g/l)

ApolipoproteinA1 is determined by using turbimetric method

Time frame: 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.).

Time frame: week 0, 12, 24, and month 12 and 24.

BMI (kg/m2)

Body mass index