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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Sophiahemmet University
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- HbA1c (mmol/mol)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Unn-Britt Johansson
Unn-Britt Johansson
Sophiahemmet University
Eligibility 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.
Outcomes
Primary Outcomes
HbA1c (mmol/mol)
Time Frame: up to month 24.
Haemoglobin A1c
Secondary Outcomes
- ApoA1 (g/l)(week 0, 24 and month 24.)
- Total cholesterol (mmol/L)(week 0, 12, 24, and month 12 and 24.)
- IGF BP1 (μg/L)(week 0, 12, 24, and month 12 and 24.)
- % Body Fat(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Triglycerides (mmol/L)(week 0, 12, 24, and month 12, 18 and 24.)
- Physical activity level (counts/min)(week 0 and month 6, 12, 18, 24)
- HDL (mmol/L)(week 0, 12, 24, and month 12, 18 and 24.)
- C-peptide (pmol/l)(week 0, 12, 24, and month 12 and 24.)
- Waist circumference (cm)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Change in Smoking and snuffing habits(Evaluation is conducted at baseline and at 24 months after completion of the intervention period)
- fasting plasma glucose (mmol/L)(week 0, 12, 24, and month 9, 12, 18 and 24.)
- Steps/day(week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.)
- fasting-Insulin (mU/l)(week 0, 12, 24, and month 12 and 24.)
- Free fatty acids (mmol(L )(week 0, 12, 24, and month 12 and 24.)
- ApoB (g/l)(week 0, 24 and month 24.)
- LDL (mmol/L)(week 0, 12, 24, and month 12 and 24.)
- BMI (kg/m2)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Weight (kg)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Sagittal Abdominal Diameter (cm)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)
- Muscle strength(week 0, 12, 24, and month 9, 12, 18 and 24.)
- Resting blood pressure (mmHg)(week 0,8, 12,16, 24, and month 9, 12, 18 and 24.)