STOP DIABETES - Knowledge-based Solutions

Physical Activity Clinical Trial

— StopDia  

Official title:

STOP DIABETES - Knowledge-based Solutions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156478
• Other study ID #: 467/2016
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet Habit
• Empowerment
• Life Style
• Physical Activity
• Type2 Diabetes

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

External Links

•   short description in English