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

Sophiahemmet University

Status: Completed

Conditions: Prediabetes; Type 2 Diabetes

Treatments: Behavioral: Pedometer intervention; Behavioral: Individual consultations; Behavioral: Group meetings

Study type: Interventional

Funder types: Other

Identifiers

NCT02374788

SophiahemmetU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 3 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Behavioral: Group meetings

Behavioral: Individual consultations

Behavioral: Pedometer intervention

Group B

Experimental group

Description:

Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years.

Treatment:

Behavioral: Pedometer intervention

Group C

No Intervention group

Description:

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.