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

Primary Purpose

Type 2 Diabetes, Prediabetes

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Pedometer intervention

Group meetings

Individual consultations

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sophiahemmet University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Group A

Group B

Group C

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

HbA1c (mmol/mol)

Haemoglobin A1c

Secondary Outcome Measures

fasting plasma glucose (mmol/L)

Determined by a glucose oxidase method

Physical activity level (counts/min)

Actigraph accelerometer GT1M

Steps/day

Actigraph accelerometer GT1M

fasting-Insulin (mU/l)

Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia & Upjohn, Stockholm.

LDL (mmol/L)

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

Total cholesterol (mmol/L)

total Cholesterol is determined by using enzymatic method

IGF BP1 (μg/L)

insulin-like growth factor binding protein 1

Free fatty acids (mmol(L )

Samples are saved for later free fatty acid analyses.

Triglycerides (mmol/L)

Triglycerides is determined by using enzymatic method (Triglycerides)

HDL (mmol/L)

HDL is determined by using a homogeneous method (lowdensity lipoprotein)(High-density lipoprotein)

ApoB (g/l)

Apolipoprotein B is determined by using turbimetric method

ApoA1 (g/l)

ApolipoproteinA1 is determined by using turbimetric method

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.).

BMI (kg/m2)

Body mass index

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.

% Body Fat

% Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL).

Waist circumference (cm)

Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus.

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).

Resting blood pressure (mmHg)

diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort.

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).

Change in Smoking and snuffing habits

Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose

Full Information

NCT ID

NCT02374788

First Posted

January 28, 2015

Last Updated

March 9, 2020

Sponsor

Sophiahemmet University

Collaborators

Karolinska Institutet, Uppsala University, Arizona State University

1. Study Identification

Unique Protocol Identification Number

NCT02374788

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

February 17, 2020 (Actual)

Study Completion Date

February 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sophiahemmet University

Collaborators

Karolinska Institutet, Uppsala University, Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Prediabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group C

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Pedometer intervention

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Group meetings

Intervention Description

Participants receive 12 group meetings over two years' time.

Intervention Type

Behavioral

Intervention Name(s)

Individual consultations

Intervention Description

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.

Primary Outcome Measure Information:

Title

HbA1c (mmol/mol)

Description

Haemoglobin A1c

Time Frame

up to month 24.

Secondary Outcome Measure Information:

Title

fasting plasma glucose (mmol/L)

Description

Determined by a glucose oxidase method

Time Frame

week 0, 12, 24, and month 9, 12, 18 and 24.

Title

Physical activity level (counts/min)

Description

Actigraph accelerometer GT1M

Time Frame

week 0 and month 6, 12, 18, 24

Title

Steps/day

Description

Actigraph accelerometer GT1M

Time Frame

week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.

Title

fasting-Insulin (mU/l)

Description

Serum insulin concentrations are determined with RIA-kits purchased from Pharmacia & Upjohn, Stockholm.

Time Frame

week 0, 12, 24, and month 12 and 24.

Title

LDL (mmol/L)

Description

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

Time Frame

week 0, 12, 24, and month 12 and 24.

Title

Total cholesterol (mmol/L)

Description

total Cholesterol is determined by using enzymatic method

Time Frame

week 0, 12, 24, and month 12 and 24.

Title

IGF BP1 (μg/L)

Description

insulin-like growth factor binding protein 1

Time Frame

week 0, 12, 24, and month 12 and 24.

Title

Free fatty acids (mmol(L )

Description

Samples are saved for later free fatty acid analyses.

Time Frame

week 0, 12, 24, and month 12 and 24.

Title

Triglycerides (mmol/L)

Description

Triglycerides is determined by using enzymatic method (Triglycerides)

Time Frame

week 0, 12, 24, and month 12, 18 and 24.

Title

HDL (mmol/L)

Description

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.

Title

ApoB (g/l)

Description

Apolipoprotein B is determined by using turbimetric method

Time Frame

week 0, 24 and month 24.

Title

ApoA1 (g/l)

Description

ApolipoproteinA1 is determined by using turbimetric method

Time Frame

week 0, 24 and month 24.

Title

C-peptide (pmol/l)

Description

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.

Title

BMI (kg/m2)

Description

Body mass index

Time Frame

week 0,8, 12,16, 24, and month 9, 12, 18 and 24.

Title

Weight (kg)

Description

Tanita digital scale (Model TBF- 300A, Arlington Heights, IL). Weight is measured with light clothes, no shoes to the nearest 0.1 kg.

Time Frame

week 0,8, 12,16, 24, and month 9, 12, 18 and 24.

Title

% Body Fat

Description

% Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL).

Time Frame

week 0,8, 12,16, 24, and month 9, 12, 18 and 24.

Title

Waist circumference (cm)

Description

Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus.

Time Frame

week 0,8, 12,16, 24, and month 9, 12, 18 and 24.

Title

Sagittal Abdominal Diameter (cm)

Description

Time Frame

week 0,8, 12,16, 24, and month 9, 12, 18 and 24.

Title

Resting blood pressure (mmHg)

Description

diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort.

Time Frame

week 0,8, 12,16, 24, and month 9, 12, 18 and 24.

Title

Muscle strength

Description

Time Frame

week 0, 12, 24, and month 9, 12, 18 and 24.

Title

Change in Smoking and snuffing habits

Description

Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose

Time Frame

Evaluation is conducted at baseline and at 24 months after completion of the intervention period

Other Pre-specified Outcome Measures:

Title

Change in Dietary habits

Description

Change in Dietary habits is measured by a set of questions developed and validated by The Swedish National Food Agency.

Time Frame

Evaluation is conducted at baseline and at week 8, 12, 24 and month 12 and 24 after completion of the intervention period

Title

Change in Alcohol habits

Description

Change in Alcohol habits is measured by two questions from AUDIT-The alcohol Use disorders

Time Frame

Evaluation is conducted at baseline and at week 24 and month 12 and 24 after completion of the intervention period

Title

Change in Stress and working condition

Description

Change in Stress and working condition is measured by four questions

Time Frame

Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period

Title

EuroQol (EQ-5D)

Description

measured by EQ-5D assess components of health related QoL (HRQoL). EQ-5D includes measures related to mobility, hygiene, daily activities, pain/ discomfort and anxiety/depression.

Time Frame

week 0, 12, 24 and month 12 and 24

Title

Sleep

Description

Sleep is measured by two questions. One question on difficulties falling asleep and one question on sleep quality.

Time Frame

Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period

Title

Self reported physical activity

Description

International Physical Activity Questionnaire (IPAQ) self-reported 7-item questionnaire to assess physical activity.

Time Frame

week 0, 12, 24 and month 12 and 24

Title

Self-efficacy for exercise

Description

The questionnaire Self-efficacy for exercise is a 5 item questionnaire and assess one´s confidence to continue exercising in different situations.

Time Frame

week 0, 12, 24 and month 12 and 24

Title

Physical Activity Social Support (PASS)

Description

Physical Activity Social Support (PASS) for exercise 6 items.

Time Frame

week 0, 12, 24 and month 12 and 24

Title

Change in Neighborhood Environment

Description

Change in Neighborhood Environment is measured by 17 questions about Walking Environment, Availability of healthy Foods, Safety and Social cohesion

Time Frame

Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period

Title

Change in Perceived Stress Scale (PSS)

Description

Change in Perceived Stress is measured by the Perceived Stress Scale (PSS) which is a 14- items questionnaire.

Time Frame

Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period

Title

Change in diabetes distress (PAID-20)

Description

Diabetes distress is measured by The Problem Areas in Diabetes questionnaire (Swe-PAID-20): This is a 20 items questionnaire

Time Frame

Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period

Title

Hospital Anxiety and Depression Scale (HADS)

Description

HADS is a 14 item questionnaire and consists of two subscales depression and anxiety, with seven items each.

Time Frame

week 0, 12, 24 and month 12 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Unn-Britt Johansson, Professor

Organizational Affiliation

Sophiahemmet University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sophiahemmet University

City

Stockholm

ZIP/Postal Code

114 86

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26164092

Citation

Rossen J, Yngve A, Hagstromer M, Brismar K, Ainsworth BE, Iskull C, Moller P, Johansson UB. Physical activity promotion in the primary care setting in pre- and type 2 diabetes - the Sophia step study, an RCT. BMC Public Health. 2015 Jul 12;15:647. doi: 10.1186/s12889-015-1941-9.

Results Reference

background

PubMed Identifier

34496859

Citation

Rossen J, Larsson K, Hagstromer M, Yngve A, Brismar K, Ainsworth B, Aberg L, Johansson UB. Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes-the Sophia Step Study. Int J Behav Nutr Phys Act. 2021 Sep 8;18(1):121. doi: 10.1186/s12966-021-01193-w.

Results Reference

derived

PubMed Identifier

34157994

Citation

Rossen J, Hagstromer M, Yngve A, Brismar K, Ainsworth B, Johansson UB. Process evaluation of the Sophia Step Study- a primary care based three-armed randomized controlled trial using self-monitoring of steps with and without counseling in prediabetes and type 2 diabetes. BMC Public Health. 2021 Jun 22;21(1):1191. doi: 10.1186/s12889-021-11222-9.

Results Reference

derived

PubMed Identifier

31663410

Citation

Rossen J, Von Rosen P, Johansson UB, Brismar K, Hagstromer M. Associations of physical activity and sedentary behavior with cardiometabolic biomarkers in prediabetes and type 2 diabetes: a compositional data analysis. Phys Sportsmed. 2020 May;48(2):222-228. doi: 10.1080/00913847.2019.1684811. Epub 2019 Nov 12.

Results Reference

derived

Links:

URL

http://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-1941-9

Description

Study protocol

Learn more about this trial

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

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