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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03156478
Other study ID # 467/2016
Secondary ID
Status Recruiting
Phase N/A
First received April 13, 2017
Last updated May 15, 2017
Start date April 10, 2017
Est. completion date December 2037

Study information

Verified date May 2017
Source University of Eastern Finland
Contact Jussi Pihlajamäki, MD, PhD
Phone +358 50 344 0187
Email jussi.pihlajamaki@uef.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 2037
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Digital lifestyle intervention group
Intervention with digital application for lifestyle changes
Combined digital and face-to-face lifestyle intervention group
Intervention with digital application and group meetings for lifestyle changes

Locations

Country Name City State
Finland University of Eastern Finland Kuopio

Sponsors (15)

Lead Sponsor Collaborator
University of Eastern Finland Cornell University, Danube-University, Flinders University, Karolinska Institutet, Maastricht University, National Institute of Health and Welfare, Roskilde University, Technical Research Centre of Finland, University of Copenhagen, University of Konstanz, University of Manchester, University of Melbourne, University of Oslo, University of York

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
Primary Change in total physical activity level Change in total physical activity level is assessed by the physical activity questionnaire. 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
Primary Change in plasma glucose levels Assessed in the 2 hour oral glucose tolerance tests 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
Primary Change in body weight Assessed with digital weight scales 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 Change in waist circumference Assessed with validated guidelines for the measure 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 Change in insulin concentration Assessed in the 2 hour oral glucose tolerance tests 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 Change in glycated hemoglobin Assessed from fasting blood sample 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 Change in plasma lipid concentration Plasma total, HDL and LDL cholesterol, and triglyceride concentrations are 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 Change in resting blood pressure Resting systolic and diastolic blood pressure is measured by automatic sphygmomanometer in sitting position. 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 Change in inflammation markers Serum high-sensitivity C-reactive protein (hs-CRP) and interleukine-1Ra (IL-1Ra) are measured as biomarkers of inflammation. 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 Change in liver function Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are measured as biomarkers of 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.
Secondary 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 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 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. 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 Change in sleeping behavior Formulated according to sleeping behavior questionnaire 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 Change in smoking behavior Assessed by questionnaire 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 Change in alcohol consumption Assessed by food frequency questionnaire 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 Change in eating behavior Eating behavior is assessed by questionnaires. 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 Change in mental wellbeing Change in mental wellbeing is assessed by questionnaire. 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 Change in quality of life Quality of life is assessed by questionnaire. 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 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. 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 Work ability and associated costs Work ability is assessed by questionnaire. Associated costs are calculated based on these data. 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 User experience of the Internet intervention Measured by the questionnaires. During the intervention at the time point of two weeks, and at one year follow-up
Secondary Usage of the Internet intervention Measured by the log data During the intervention at the time point of two weeks, 3 months, 6 months, and at one year follow-up
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