Diet Habit, Empowerment, Life Style, Physical Activity, Type2 Diabetes
Conditions
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
Brief 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 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.
Interventions
BEHAVIORALDigital lifestyle intervention group
Intervention with digital application for lifestyle changes
BEHAVIORALCombined digital and face-to-face lifestyle intervention group
Intervention with digital application and group meetings for lifestyle changes
Sponsors
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
University of Eastern Finland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* type 1 or 2 diabetes * pregnancy or breastfeeding * current cancer or less than 6 months from the end of cancer treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in diet | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated hemoglobin | 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 from fasting blood sample |
| Change in plasma lipid concentration | 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 | Plasma total, HDL and LDL cholesterol, and triglyceride concentrations are measured. |
| Change in resting blood pressure | 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. | Resting systolic and diastolic blood pressure is measured by automatic sphygmomanometer in sitting position. |
| Change in inflammation markers | 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. | Serum high-sensitivity C-reactive protein (hs-CRP) and interleukine-1Ra (IL-1Ra) are measured as biomarkers of inflammation. |
| Change in liver function | 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. | Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are measured as biomarkers of liver function. |
| Change in metabolite profiles | 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 | Metabolites and metabolic profiles related to diet, other lifestyle factors and predicting type 2 diabetes measured from serum and plasma samples |
| Change in sedentary behavior | 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 is described as the total amount spent in sitting and lying position during waking hours, and is assessed by the questionnaire. |
| Change in smoking behavior | 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 by questionnaire |
| Change in eating behavior | 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 | Eating behavior is assessed by questionnaires. |
| Change in mental wellbeing | 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 is assessed by questionnaire. |
| Change in quality of life | 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. | Quality of life is assessed by questionnaire. |
| Use of health-care services and associated costs | 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 are assessed by questionnaire and registers. Associated costs are calculated based on these data. |
| Work ability and associated costs | 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 is assessed by questionnaire. Associated costs are calculated based on these data. |
| User experience of the Internet intervention | During the intervention at the time point of two weeks, and at one year follow-up | Measured by the questionnaires. |
| Usage of the Internet intervention | During the intervention at the time point of two weeks, 3 months, 6 months, and at one year follow-up | Measured by the log data |
| Change in sleeping behavior | 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 | Formulated according to sleeping behavior questionnaire |
| Change in alcohol consumption | 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 by food frequency questionnaire |
| Change in waist circumference | 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 validated guidelines for the measure |
| Change in insulin concentration | 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 |
Countries
Finland
Contacts
Primary ContactJussi Pihlajamäki, MD, PhD
Backup ContactTimo A Lakka, MD, PhD
Outcome results
None listed