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

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Prediabetes
• Interventions: Behavioral: Pedometer intervention; Behavioral: Group meetings; Behavioral: Individual consultations

• Registration Number: NCT02374788
• Lead Sponsor: Sophiahemmet University

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Pedometer intervention	Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years.
Group A	Pedometer intervention	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.
Group A	Group meetings	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.
Group A	Individual consultations	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.

Primary Outcome Measures

Name	Time	Method
HbA1c (mmol/mol)	up to month 24.	Haemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Total cholesterol (mmol/L)	week 0, 12, 24, and month 12 and 24.	total Cholesterol is determined by using enzymatic method
ApoA1 (g/l)	week 0, 24 and month 24.	ApolipoproteinA1 is determined by using turbimetric method
IGF BP1 (μg/L)	week 0, 12, 24, and month 12 and 24.	insulin-like growth factor binding protein 1
% Body Fat	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).
Triglycerides (mmol/L)	week 0, 12, 24, and month 12, 18 and 24.	Triglycerides is determined by using enzymatic method (Triglycerides)
Physical activity level (counts/min)	week 0 and month 6, 12, 18, 24	Actigraph accelerometer GT1M
HDL (mmol/L)	week 0, 12, 24, and month 12, 18 and 24.	HDL is determined by using a homogeneous method (lowdensity lipoprotein)(High-density lipoprotein)
C-peptide (pmol/l)	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.).
Waist circumference (cm)	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.
Change in Smoking and snuffing habits	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
fasting plasma glucose (mmol/L)	week 0, 12, 24, and month 9, 12, 18 and 24.	Determined by a glucose oxidase method
Steps/day	week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.	Actigraph accelerometer GT1M
fasting-Insulin (mU/l)	week 0, 12, 24, and month 12 and 24.	Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia \& Upjohn, Stockholm.
Free fatty acids (mmol(L )	week 0, 12, 24, and month 12 and 24.	Samples are saved for later free fatty acid analyses.
ApoB (g/l)	week 0, 24 and month 24.	Apolipoprotein B is determined by using turbimetric method
LDL (mmol/L)	week 0, 12, 24, and month 12 and 24.	LDL is determined by using a homogeneous method (lowdensity lipoprotein)
BMI (kg/m2)	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.	Body mass index
Weight (kg)	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.
Sagittal Abdominal Diameter (cm)	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).
Muscle strength	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).
Resting blood pressure (mmHg)	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.

Trial Locations

Locations (1)

Sophiahemmet University; 🇸🇪 Stockholm, Sweden