Type2 DiabetesStopDiaNCT03156478
STOP DIABETES - Knowledge-based Solutions
A study testing Digital lifestyle intervention group and Combined digital and face-to-face lifestyle intervention group in people with Type2 Diabetes and Life Style, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project (University of Eastern Finland, National Institute for Health and Welfare, and Technical Research Centre of Finland) is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Life Style, Diet Habit
- What is being tested?
- Digital lifestyle intervention group and Combined digital and face-to-face lifestyle intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteFinland
- Study dates
- 10 Apr 2017to Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age of 18-70 years
- 12 points or more in the Finnish diabetes risk score or previous gestational diabetes or repeated impaired fasting glucose (IFG) (fasting plasma glucose level 6,1 - 6,9 mmol/l) or impaired glucose tolerance (2-hour glucose level 7,8 - 11,0 mmol/l in oral glucose tolerance test)
- living in the hospital district of Northern Savo, Päijät-Häme or South Karelia
- possibility to use computer, smartphone or tablet with internet connection
- having own self-phone number
- adequate Finnish language skill
Who cannot join
- type 1 or 2 diabetes
- pregnancy or breastfeeding
- current cancer or less than 6 months from the end of cancer treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
University of Eastern Finland
Kuopio
Jussi Pihlajamäki, MD, PhD, +358 50 344 0187, jussi.pihlajamaki@uef.fi
About this study
The aim of the Stop Diabetes - Knowledge based solutions (StopDia) consortium project (University of Eastern Finland, National Institute for Health and Welfare, and Technical Research Centre of Finland) is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will carry out a 1-year randomized controlled trial on the effects of among 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes.
Read the detailed description
Type 2 diabetes is a major public health and economical problem all over the world, including Finland. A healthy diet and physical activity are the cornerstones for the prevention of type 2 diabetes. The aim of the Stop Diabetes - Knowledge based solutions (StopDia) study is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will recruit 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in the hospital district of Northern Savo, Päijät-Häme, or South Karelia in Finland for a 1-year randomized controlled trial. We will assess body height and weight, body mass index, waist circumference, and blood pressure, take blood samples for biochemical analyses, and perform a 2-hour oral glucose tolerance test at baseline. The participants will be asked to fill out a detailed digital questionnaire on factors related to the risk of type 2 diabetes, including diet, physical activity, sedentary behavior, health status, physical, psychic, and social well-being, as well as the use of health care services and medications. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes. We will also investigate the effects of environmental interventions at certain workplaces and the synergistic effects of the individual level and environmental interventions in a subsample of the study population. All baseline assessments will be repeated after the 1-year follow-up. The primary outcomes will be the changes in diet, total physical activity, body weight, and plasma glucose levels from the oral glucose tolerance test. After the 1-year intervention study, follow-up examinations will be performed 3, 5, 10, 15, and 20 years after the baseline examinations.
- Conditions
- Type2 Diabetes, Life Style, Diet Habit, Physical Activity, Empowerment
- Being tested
- Digital lifestyle intervention group, Combined digital and face-to-face lifestyle intervention group
- Keywords
- Prevention, Digital solutions, Type 2 diabetes, Life style modification, Physical activity, Healthy diet, Health economics, Environmental choice architecture, Socio-economic facilitators, Socio-economic barriers, Wellbeing
- Medical subject headings
- Feeding Behavior, Motor Activity, Empowerment, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital lifestyle intervention groupBehavioural
Intervention with digital application for lifestyle changes
Combined digital and face-to-face lifestyle intervention groupBehavioural
Intervention with digital application and group meetings for lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | At baseline, individuals in the control group receive digital information package about lifestyle risk factors of type 2 diabetes with recommendations on healthy diet and physical activity in accordance with the Finnish Nutrition Recommendations and the national recommendation for health enhancing physical activity. |
| Digital lifestyle intervention group | Experimental | Participants are instructed to use a digital self-help tool for 12 months. This tool is developed in the StopDia-study to enact positive changes in participant's health behaviour. The digital intervention consists of 2 components which motivate, enable and trigger the participants to improve their health behaviours. B.J. Fogg's Tiny Habits -ideology. The digital intervention is based on the Fogg Behaviour Model (FBM) and the Behaviour Wizard. Receives: Behavioral: Digital lifestyle intervention group |
| Combined digital and face-to-face lifestyle intervention group | Experimental | Participants are using the StopDia digital solution tool as described above. In addition, they have six face-to-face group coaching (6-15 participants/group) sessions at local health centers facilitated by trained nurses. The face-to-face group intervention is based on the Self-Determination Theory and theories of self-regulation, and delivered using intrinsic motivational coaching approach designed and tested in the GOAL lifestyle intervention, and further developed in several other studies in Finland and internationally. Receives: Behavioral: Combined digital and face-to-face lifestyle intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet
Change in diet is assessed by the dietary score based on Finnish Nutrition Recommendations and is formulated according to food frequency questionnaire.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in total physical activity level
Change in total physical activity level is assessed by the physical activity questionnaire.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in plasma glucose levels
Assessed in the 2 hour oral glucose tolerance tests
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in body weight
Assessed with digital weight scales
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Secondary outcomes (19)
Change in waist circumference
Assessed with validated guidelines for the measure
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in insulin concentration
Assessed in the 2 hour oral glucose tolerance tests
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in glycated hemoglobin
Assessed from fasting blood sample
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in plasma lipid concentration
Plasma total, HDL and LDL cholesterol, and triglyceride concentrations are measured.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in resting blood pressure
Resting systolic and diastolic blood pressure is measured by automatic sphygmomanometer in sitting position.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Change in inflammation markers
Serum high-sensitivity C-reactive protein (hs-CRP) and interleukine-1Ra (IL-1Ra) are measured as biomarkers of inflammation.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Change in liver function
Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are measured as biomarkers of liver function.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Change in metabolite profiles
Metabolites and metabolic profiles related to diet, other lifestyle factors and predicting type 2 diabetes measured from serum and plasma samples
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in sedentary behavior
Change in sedentary behavior is described as the total amount spent in sitting and lying position during waking hours, and is assessed by the questionnaire.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in sleeping behavior
Formulated according to sleeping behavior questionnaire
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in smoking behavior
Assessed by questionnaire
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in alcohol consumption
Assessed by food frequency questionnaire
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in eating behavior
Eating behavior is assessed by questionnaires.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in mental wellbeing
Change in mental wellbeing is assessed by questionnaire.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in quality of life
Quality of life is assessed by questionnaire.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Use of health-care services and associated costs
Use of health-care services are assessed by questionnaire and registers. Associated costs are calculated based on these data.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Work ability and associated costs
Work ability is assessed by questionnaire. Associated costs are calculated based on these data.
Measured: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
User experience of the Internet intervention
Measured by the questionnaires.
Measured: During the intervention at the time point of two weeks, and at one year follow-up
Usage of the Internet intervention
Measured by the log data
Measured: During the intervention at the time point of two weeks, 3 months, 6 months, and at one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start10 Apr 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2037 (estimated)
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 Type2 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in 3 groups: 1) control group, 2) digital lifestyle intervention group and 3) combined digital and face-to-face lifestyle intervention group. Environmental changes will be done within some work places.Part of the participants in each group may be exposed to environmental modification that are aimed for lifestyle changes at work places.
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health and Welfare, Technical Research Centre of Finland, University of Melbourne, University of Konstanz, Karolinska Institutet, Maastricht University, University of Oslo, Danube-University, Flinders University, Cornell University, University of Copenhagen, Roskilde University, University of Manchester, University of York
- Responsible party
- Sponsor
- Investigators
- Jussi Pihlajamäki, MD, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156478
- Sponsor's protocol ID
- 467/2016
- Acronym
- StopDia
- Status last verified
- May 2017
- First submitted
- 13 Apr 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manninen S, Tilles-Tirkkonen T, Aittola K, Mannikko R, Karhunen L, Kolehmainen M, Schwab U, Lindstrom J, Lakka T, Pihlajamaki J; Stop Diabetes study group. Associations of Lifestyle Patterns with Glucose and Lipid Metabolism in Finnish Adults at Increased Risk of Type 2 Diabetes. Mol Nutr Food Res. 2024 Mar;68(5):e2300338. doi: 10.1002/mnfr.202300338. Epub 2024 Feb 2.
PubMed 38308150Lakka TA, Aittola K, Jarvela-Reijonen E, Tilles-Tirkkonen T, Mannikko R, Lintu N, Karhunen L, Kolehmainen M, Harjumaa M, Mattila E, Jarvenpaa R, Ermes M, Mikkonen S, Martikainen J, Poutanen K, Schwab U, Absetz P, Lindstrom J, Pihlajamaki J. Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial. Lancet Reg Health Eur. 2023 Jan;24:100527. doi: 10.1016/j.lanepe.2022.100527. Epub 2022 Oct 12.
PubMed 36620354Lavikainen P, Mattila E, Absetz P, Harjumaa M, Lindstrom J, Jarvela-Reijonen E, Aittola K, Mannikko R, Tilles-Tirkkonen T, Lintu N, Lakka T, van Gils M, Pihlajamaki J, Martikainen J. Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial. J Med Internet Res. 2022 Feb 24;24(2):e31530. doi: 10.2196/31530.
PubMed 35200147Karlund A, Kaariainen T, Kostamo VM, Kokkola T, Kolehmainen M, Lakka TA, Pihlajamaki J, Manninen A. Oxygen-18 and carbon-13 isotopes in eCO2and erythrocytes carbonic anhydrase activity of Finnish prediabetic population. J Breath Res. 2021 Jan 22;15(2). doi: 10.1088/1752-7163/abd28d.
PubMed 33302264Harjumaa M, Absetz P, Ermes M, Mattila E, Mannikko R, Tilles-Tirkkonen T, Lintu N, Schwab U, Umer A, Leppanen J, Pihlajamaki J. Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial. JMIR Diabetes. 2020 Aug 11;5(3):e15219. doi: 10.2196/15219.
PubMed 32779571Pihlajamaki J, Mannikko R, Tilles-Tirkkonen T, Karhunen L, Kolehmainen M, Schwab U, Lintu N, Paananen J, Jarvenpaa R, Harjumaa M, Martikainen J, Kohl J, Poutanen K, Ermes M, Absetz P, Lindstrom J, Lakka TA; StopDia study group. Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial. BMC Public Health. 2019 Mar 1;19(1):255. doi: 10.1186/s12889-019-6574-y.
PubMed 30823909
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP DIABETES - Knowledge-based Solutions
- ClinicalTrials.gov ID
- NCT03156478
- Acronym / sponsor ID
- StopDia / 467/2016
- Conditions
- Type2 Diabetes, Life Style, Diet Habit, Physical Activity, Empowerment
- Keywords
- Prevention, Digital solutions, Type 2 diabetes, Life style modification, Physical activity, Healthy diet, Health economics, Environmental choice architecture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- National Institute of Health and Welfare, Technical Research Centre of Finland, University of Melbourne, University of Konstanz, Karolinska Institutet, Maastricht University, University of Oslo, Danube-University, Flinders University, Cornell University, University of Copenhagen, Roskilde University, University of Manchester, University of York
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 17 May 2017 (actual)
- 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 Stop Diabetes - Knowledge based solutions (StopDia) consortium project (University of Eastern Finland, National Institute for Health and Welfare, and Technical Research Centre of Finland) is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will carry out a 1-year randomized controlled trial on the effects of among 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in Finland. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes.
Detailed description
Type 2 diabetes is a major public health and economical problem all over the world, including Finland. A healthy diet and physical activity are the cornerstones for the prevention of type 2 diabetes. The aim of the Stop Diabetes - Knowledge based solutions (StopDia) study is to develop and test approaches to identify individuals at increased risk of type 2 diabetes and to empower them in adopting and maintaining a healthy lifestyle by combining individual and environment level strategies into a dual-process approach targeting deliberative and automatic processes of behavior. We also aim to identify barriers and facilitators of adopting a healthy lifestyle in the society, create a model for the prevention of type 2 diabetes by joint actions of health care, third sector, and other societal actors, and develop methods to monitor the cost-effectiveness of these actions. We will recruit 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in the hospital district of Northern Savo, Päijät-Häme, or South Karelia in Finland for a 1-year randomized controlled trial. We will assess body height and weight, body mass index, waist circumference, and blood pressure, take blood samples for biochemical analyses, and perform a 2-hour oral glucose tolerance test at baseline. The participants will be asked to fill out a detailed digital questionnaire on factors related to the risk of type 2 diabetes, including diet, physical activity, sedentary behavior, health status, physical, psychic, and social well-being, as well as the use of health care services and medications. The participants will be randomized into the control group, the digital lifestyle intervention group, or the combined digital and face-to-face lifestyle intervention group. The aim of the interventions is to enhance diet quality, increase physical activity, decrease body weight, and improve glucose tolerance in individuals at increased risk of type 2 diabetes. We will also investigate the effects of environmental interventions at certain workplaces and the synergistic effects of the individual level and environmental interventions in a subsample of the study population. All baseline assessments will be repeated after the 1-year follow-up. The primary outcomes will be the changes in diet, total physical activity, body weight, and plasma glucose levels from the oral glucose tolerance test. After the 1-year intervention study, follow-up examinations will be performed 3, 5, 10, 15, and 20 years after the baseline examinations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in 3 groups: 1) control group, 2) digital lifestyle intervention group and 3) combined digital and face-to-face lifestyle intervention group. Environmental changes will be done within some work places.Part of the participants in each group may be exposed to environmental modification that are aimed for lifestyle changes at work places.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –At baseline, individuals in the control group receive digital information package about lifestyle risk factors of type 2 diabetes with recommendations on healthy diet and physical activity in accordance with the Finnish Nutrition Recommendations and the national recommendation for health enhancing physical activity. |
| Digital lifestyle intervention group | Experimental | Behavioral: Digital lifestyle intervention groupParticipants are instructed to use a digital self-help tool for 12 months. This tool is developed in the StopDia-study to enact positive changes in participant's health behaviour. The digital intervention consists of 2 components which motivate, enable and trigger the participants to improve their health behaviours. B.J. Fogg's Tiny Habits -ideology. The digital intervention is based on the Fogg Behaviour Model (FBM) and the Behaviour Wizard. |
| Combined digital and face-to-face lifestyle intervention group | Experimental | Behavioral: Combined digital and face-to-face lifestyle intervention groupParticipants are using the StopDia digital solution tool as described above. In addition, they have six face-to-face group coaching (6-15 participants/group) sessions at local health centers facilitated by trained nurses. The face-to-face group intervention is based on the Self-Determination Theory and theories of self-regulation, and delivered using intrinsic motivational coaching approach designed and tested in the GOAL lifestyle intervention, and further developed in several other studies in Finland and internationally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age of 18-70 years
- 12 points or more in the Finnish diabetes risk score or previous gestational diabetes or repeated impaired fasting glucose (IFG) (fasting plasma glucose level 6,1 - 6,9 mmol/l) or impaired glucose tolerance (2-hour glucose level 7,8 - 11,0 mmol/l in oral glucose tolerance test)
- living in the hospital district of Northern Savo, Päijät-Häme or South Karelia
- possibility to use computer, smartphone or tablet with internet connection
- having own self-phone number
Key exclusion criteria (3 listed)
- type 1 or 2 diabetes
- pregnancy or breastfeeding
- current cancer or less than 6 months from the end of cancer treatment
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 |
|---|---|---|
| Digital lifestyle intervention groupIntervention with digital application for lifestyle changes | Behavioural | Digital lifestyle intervention group |
| Combined digital and face-to-face lifestyle intervention groupIntervention with digital application and group meetings for lifestyle changes | Behavioural | Combined digital and face-to-face lifestyle intervention group |
Primary outcome
Change in diet
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in diet is assessed by the dietary score based on Finnish Nutrition Recommendations and is formulated according to food frequency questionnaire.
Change in total physical activity level
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in total physical activity level is assessed by the physical activity questionnaire.
Change in plasma glucose levels
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Assessed in the 2 hour oral glucose tolerance tests
Change in body weight
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Assessed with digital weight scales
19 secondary outcomes
Change in waist circumference
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in insulin concentration
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in glycated hemoglobin
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in plasma lipid concentration
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in resting blood pressure
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Change in inflammation markers
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Change in liver function
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Change in metabolite profiles
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in sedentary behavior
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in sleeping behavior
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in smoking behavior
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in alcohol consumption
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in eating behavior
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in mental wellbeing
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Change in quality of life
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
Use of health-care services and associated costs
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up
Work ability and associated costs
Time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up.
User experience of the Internet intervention
Time frame: During the intervention at the time point of two weeks, and at one year follow-up
Usage of the Internet intervention
Time frame: During the intervention at the time point of two weeks, 3 months, 6 months, and at one year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 38308150Manninen S, Tilles-Tirkkonen T, Aittola K, Mannikko R, Karhunen L, Kolehmainen M, Schwab U, Lindstrom J, Lakka T, Pihlajamaki J; Stop Diabetes study group. Associations of Lifestyle Patterns with Glucose and Lipid Metabolism in Finnish Adults at Increased Risk of Type 2 Diabetes. Mol Nutr Food Res. 2024 Mar;68(5):e2300338. doi: 10.1002/mnfr.202300338. Epub 2024 Feb 2.
- Derived from this study: PubMed 36620354Lakka TA, Aittola K, Jarvela-Reijonen E, Tilles-Tirkkonen T, Mannikko R, Lintu N, Karhunen L, Kolehmainen M, Harjumaa M, Mattila E, Jarvenpaa R, Ermes M, Mikkonen S, Martikainen J, Poutanen K, Schwab U, Absetz P, Lindstrom J, Pihlajamaki J. Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial. Lancet Reg Health Eur. 2023 Jan;24:100527. doi: 10.1016/j.lanepe.2022.100527. Epub 2022 Oct 12.
- Derived from this study: PubMed 35200147Lavikainen P, Mattila E, Absetz P, Harjumaa M, Lindstrom J, Jarvela-Reijonen E, Aittola K, Mannikko R, Tilles-Tirkkonen T, Lintu N, Lakka T, van Gils M, Pihlajamaki J, Martikainen J. Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial. J Med Internet Res. 2022 Feb 24;24(2):e31530. doi: 10.2196/31530.
- Derived from this study: PubMed 33302264Karlund A, Kaariainen T, Kostamo VM, Kokkola T, Kolehmainen M, Lakka TA, Pihlajamaki J, Manninen A. Oxygen-18 and carbon-13 isotopes in eCO2and erythrocytes carbonic anhydrase activity of Finnish prediabetic population. J Breath Res. 2021 Jan 22;15(2). doi: 10.1088/1752-7163/abd28d.
- Derived from this study: PubMed 32779571Harjumaa M, Absetz P, Ermes M, Mattila E, Mannikko R, Tilles-Tirkkonen T, Lintu N, Schwab U, Umer A, Leppanen J, Pihlajamaki J. Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial. JMIR Diabetes. 2020 Aug 11;5(3):e15219. doi: 10.2196/15219.
- Derived from this study: PubMed 30823909Pihlajamaki J, Mannikko R, Tilles-Tirkkonen T, Karhunen L, Kolehmainen M, Schwab U, Lintu N, Paananen J, Jarvenpaa R, Harjumaa M, Martikainen J, Kohl J, Poutanen K, Ermes M, Absetz P, Lindstrom J, Lakka TA; StopDia study group. Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial. BMC Public Health. 2019 Mar 1;19(1):255. doi: 10.1186/s12889-019-6574-y.
- short description in EnglishLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Type2 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.
Jussi Pihlajamäki, MD, PhD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital lifestyle intervention group and Combined digital and face-to-face lifestyle intervention group in people with Type2 Diabetes and Life Style, run by University of Eastern Finland at 1 site in Finland.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 May 2017. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jussi Pihlajamäki, MD, PhD (+358 50 344 0187, jussi.pihlajamaki@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diet (time frame: From baseline to one year follow-up, to 3 year follow-up, to 5 year follow-up, to 10 year follow-up, to 15 year follow-up, 20 year follow-up). The study lists 4 primary outcomes in all. 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 NCT03156478, 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 17 May 2017.