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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Prediabetes
• Intervention / Treatment: Behavioral: Pedometer intervention; Behavioral: Group meetings; Behavioral: Individual consultations

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 Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 114 86
    • Sophiahemmet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Behavioral: Pedometer intervention; Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.; Behavioral: Group meetings; Participants receive 12 group meetings over two years' time.; Behavioral: Individual consultations; 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.
Experimental: Group B; Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years.	Behavioral: Pedometer intervention; Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
No Intervention: Group C; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c (mmol/mol)	Haemoglobin A1c	up to month 24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fasting plasma glucose (mmol/L)	Determined by a glucose oxidase method	week 0, 12, 24, and month 9, 12, 18 and 24.
Physical activity level (counts/min)	Actigraph accelerometer GT1M	week 0 and month 6, 12, 18, 24
Steps/day	Actigraph accelerometer GT1M	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.	week 0, 12, 24, and month 12 and 24.
LDL (mmol/L)	LDL is determined by using a homogeneous method (lowdensity lipoprotein)	week 0, 12, 24, and month 12 and 24.
Total cholesterol (mmol/L)	total Cholesterol is determined by using enzymatic method	week 0, 12, 24, and month 12 and 24.
IGF BP1 (μg/L)	insulin-like growth factor binding protein 1	week 0, 12, 24, and month 12 and 24.
Free fatty acids (mmol(L )	Samples are saved for later free fatty acid analyses.	week 0, 12, 24, and month 12 and 24.
Triglycerides (mmol/L)	Triglycerides is determined by using enzymatic method (Triglycerides)	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)	week 0, 12, 24, and month 12, 18 and 24.
ApoB (g/l)	Apolipoprotein B is determined by using turbimetric method	week 0, 24 and month 24.
ApoA1 (g/l)	ApolipoproteinA1 is determined by using turbimetric method	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.).	week 0, 12, 24, and month 12 and 24.
BMI (kg/m2)	Body mass index	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
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.	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
% Body Fat	% Body Fat is determined by Tanita digital scale (Model TBF- 300A, Arlington Heights, IL).	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Waist circumference (cm)	Waist circumference is measured with SECA 201 tape, horizontal around the waist 2 cm above the umbilicus.	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
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).	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Resting blood pressure (mmHg)	diastolic blood pressure and systolic blood pressure. Resting blood pressure is measured with Omron M6 Comfort.	week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
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).	week 0, 12, 24, and month 9, 12, 18 and 24.
Change in Smoking and snuffing habits	Change in Smoking and snuffing habits is measured with questions on current and previous habits and the dose	Evaluation is conducted at baseline and at 24 months after completion of the intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dietary habits	Change in Dietary habits is measured by a set of questions developed and validated by The Swedish National Food Agency.	Evaluation is conducted at baseline and at week 8, 12, 24 and month 12 and 24 after completion of the intervention period
Change in Alcohol habits	Change in Alcohol habits is measured by two questions from AUDIT-The alcohol Use disorders	Evaluation is conducted at baseline and at week 24 and month 12 and 24 after completion of the intervention period
Change in Stress and working condition	Change in Stress and working condition is measured by four questions	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
EuroQol (EQ-5D)	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.	week 0, 12, 24 and month 12 and 24
Sleep	Sleep is measured by two questions. One question on difficulties falling asleep and one question on sleep quality.	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Self reported physical activity	International Physical Activity Questionnaire (IPAQ) self-reported 7-item questionnaire to assess physical activity.	week 0, 12, 24 and month 12 and 24
Self-efficacy for exercise	The questionnaire Self-efficacy for exercise is a 5 item questionnaire and assess one´s confidence to continue exercising in different situations.	week 0, 12, 24 and month 12 and 24
Physical Activity Social Support (PASS)	Physical Activity Social Support (PASS) for exercise 6 items.	week 0, 12, 24 and month 12 and 24
Change in Neighborhood Environment	Change in Neighborhood Environment is measured by 17 questions about Walking Environment, Availability of healthy Foods, Safety and Social cohesion	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Change in Perceived Stress Scale (PSS)	Change in Perceived Stress is measured by the Perceived Stress Scale (PSS) which is a 14- items questionnaire.	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Change in diabetes distress (PAID-20)	Diabetes distress is measured by The Problem Areas in Diabetes questionnaire (Swe-PAID-20): This is a 20 items questionnaire	Evaluation is conducted at baseline and at week 12, 24 and month 12 and 24 after completion of the intervention period
Hospital Anxiety and Depression Scale (HADS)	HADS is a 14 item questionnaire and consists of two subscales depression and anxiety, with seven items each.	week 0, 12, 24 and month 12 and 24

Collaborators and Investigators

• Sponsor: Sophiahemmet University
• Collaborators: Karolinska Institutet; Uppsala University; Arizona State University
• Investigators: Principal Investigator: Unn-Britt Johansson, Professor, Sophiahemmet University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Study protocol

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SophiahemmetU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No