Type 2 DiabetesNCT02374788
Sophia Step Study - a Behaviour Change Program on Physical Activity in Persons With Pre- and Type 2 Diabetes
A study testing Pedometer intervention, Group meetings and Individual consultations in people with Type 2 Diabetes and Prediabetes, run by Sophiahemmet University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Prediabetes
- What is being tested?
- Pedometer intervention, Group meetings and Individual consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to 17 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Prediabetes
- Being tested
- Pedometer intervention, Group meetings, Individual consultations
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer interventionBehavioural
Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
Group meetingsBehavioural
Participants receive 12 group meetings over two years' time.
Individual consultationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Behavioral: Pedometer intervention; Behavioral: Group meetings; Behavioral: Individual consultations |
| Group B | Experimental | Participants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years. Receives: Behavioral: Pedometer intervention |
| Group C | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (mmol/mol)
Haemoglobin A1c
Measured: up to month 24.
Secondary outcomes (21)
fasting plasma glucose (mmol/L)
Determined by a glucose oxidase method
Measured: week 0, 12, 24, and month 9, 12, 18 and 24.
Physical activity level (counts/min)
Actigraph accelerometer GT1M
Measured: week 0 and month 6, 12, 18, 24
Steps/day
Actigraph accelerometer GT1M
Measured: 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.
Measured: week 0, 12, 24, and month 12 and 24.
LDL (mmol/L)
LDL is determined by using a homogeneous method (lowdensity lipoprotein)
Measured: week 0, 12, 24, and month 12 and 24.
Total cholesterol (mmol/L)
total Cholesterol is determined by using enzymatic method
Measured: week 0, 12, 24, and month 12 and 24.
IGF BP1 (μg/L)
insulin-like growth factor binding protein 1
Measured: week 0, 12, 24, and month 12 and 24.
Free fatty acids (mmol(L )
Samples are saved for later free fatty acid analyses.
Measured: week 0, 12, 24, and month 12 and 24.
Triglycerides (mmol/L)
Triglycerides is determined by using enzymatic method (Triglycerides)
Measured: 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)
Measured: week 0, 12, 24, and month 12, 18 and 24.
ApoB (g/l)
Apolipoprotein B is determined by using turbimetric method
Measured: week 0, 24 and month 24.
ApoA1 (g/l)
ApolipoproteinA1 is determined by using turbimetric method
Measured: 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.).
Measured: week 0, 12, 24, and month 12 and 24.
BMI (kg/m2)
Body mass index
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: Evaluation is conducted at baseline and at 24 months after completion of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startNov 2013
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophiahemmet University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University, Arizona State University
- Responsible party
- Principal investigator, Unn-Britt Johansson, Sophiahemmet University
- Investigators
- Unn-Britt Johansson, Professor, Principal investigator, Sophiahemmet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374788
- Sponsor's protocol ID
- SophiahemmetU
- Status last verified
- Mar 2020
- First submitted
- 28 Jan 2015
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26164092Larsson K, Von Rosen P, Rossen J, Johansson UB, Hagstromer M. Relative time in physical activity and sedentary behaviour across a 2-year pedometer-based intervention in people with prediabetes or type 2 diabetes: a secondary analysis of a randomised controlled trial. J Act Sedentary Sleep Behav. 2023 Jun 1;2(1):10. doi: 10.1186/s44167-023-00020-w.
PubMed 40217375Larsson K, Rossen J, Norman A, Johansson UB, Hagstromer M. Predictors associated with an increase in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention. BMC Public Health. 2024 May 11;24(1):1290. doi: 10.1186/s12889-024-18766-6.
PubMed 38734659Rossen 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.
PubMed 34496859Rossen 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.
PubMed 34157994Rossen 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.
PubMed 31663410
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02374788
- Acronym / sponsor ID
- SophiahemmetU
- Conditions
- Type 2 Diabetes, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Sophiahemmet UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University, Arizona State University
- Study start
- Nov 2013
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Pedometer intervention, Behavioral: Group meetings, Behavioral: Individual consultationsParticipants 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 B | Experimental | Behavioral: Pedometer interventionParticipants in the pedometer group (B) receive a pedometer intervention. Henceforth they are left to continue by they own for two years. |
| Group C | No intervention | –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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer interventionIntensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website. | Behavioural | Group A, Group B |
| Group meetingsParticipants receive 12 group meetings over two years' time. | Behavioural | Group A |
| Individual consultationsParticipants 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. | Behavioural | Group A |
Primary outcome
HbA1c (mmol/mol)
Time frame: up to month 24.
Haemoglobin A1c
21 secondary outcomes
fasting plasma glucose (mmol/L)
Time frame: week 0, 12, 24, and month 9, 12, 18 and 24.
Physical activity level (counts/min)
Time frame: week 0 and month 6, 12, 18, 24
Steps/day
Time frame: week 0, 8, 12, 16, 24, and month 9, 12, 18 and 24.
fasting-Insulin (mU/l)
Time frame: week 0, 12, 24, and month 12 and 24.
LDL (mmol/L)
Time frame: week 0, 12, 24, and month 12 and 24.
Total cholesterol (mmol/L)
Time frame: week 0, 12, 24, and month 12 and 24.
IGF BP1 (μg/L)
Time frame: week 0, 12, 24, and month 12 and 24.
Free fatty acids (mmol(L )
Time frame: week 0, 12, 24, and month 12 and 24.
Triglycerides (mmol/L)
Time frame: week 0, 12, 24, and month 12, 18 and 24.
HDL (mmol/L)
Time frame: week 0, 12, 24, and month 12, 18 and 24.
ApoB (g/l)
Time frame: week 0, 24 and month 24.
ApoA1 (g/l)
Time frame: week 0, 24 and month 24.
C-peptide (pmol/l)
Time frame: week 0, 12, 24, and month 12 and 24.
BMI (kg/m2)
Time frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Weight (kg)
Time frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
% Body Fat
Time frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Waist circumference (cm)
Time frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Sagittal Abdominal Diameter (cm)
Time frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Resting blood pressure (mmHg)
Time frame: week 0,8, 12,16, 24, and month 9, 12, 18 and 24.
Muscle strength
Time frame: week 0, 12, 24, and month 9, 12, 18 and 24.
Change in Smoking and snuffing habits
Time frame: Evaluation is conducted at baseline and at 24 months after completion of the intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 26164092Rossen 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.
- Derived from this study: PubMed 40217375Larsson K, Von Rosen P, Rossen J, Johansson UB, Hagstromer M. Relative time in physical activity and sedentary behaviour across a 2-year pedometer-based intervention in people with prediabetes or type 2 diabetes: a secondary analysis of a randomised controlled trial. J Act Sedentary Sleep Behav. 2023 Jun 1;2(1):10. doi: 10.1186/s44167-023-00020-w.
- Derived from this study: PubMed 38734659Larsson K, Rossen J, Norman A, Johansson UB, Hagstromer M. Predictors associated with an increase in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention. BMC Public Health. 2024 May 11;24(1):1290. doi: 10.1186/s12889-024-18766-6.
- Derived from this study: PubMed 34496859Rossen 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.
- Derived from this study: PubMed 34157994Rossen 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.
- Derived from this study: PubMed 31663410Rossen 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.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unn-Britt Johansson, Professor principal investigator
Sophiahemmet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer intervention, Group meetings and Individual consultations in people with Type 2 Diabetes and Prediabetes, run by Sophiahemmet University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (mmol/mol) (time frame: up to month 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374788, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.