STOP DIABETES - Knowledge-based Solutions

Not Applicable

Recruiting

• Conditions: Diet Habit; Life Style; Type2 Diabetes; Physical Activity; Empowerment
• Interventions: Behavioral: Digital lifestyle intervention group; Behavioral: Combined digital and face-to-face lifestyle intervention group

• Registration Number: NCT03156478
• Lead Sponsor: University of Eastern Finland

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.

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-04-13
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17
• Primary Completion: 2018-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital lifestyle intervention group	Digital lifestyle intervention group	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.
Combined digital and face-to-face lifestyle intervention group	Combined digital and face-to-face lifestyle intervention group	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.

Primary Outcome Measures

Name	Time	Method
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
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 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 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.

Secondary Outcome Measures

Name	Time	Method
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
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.
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 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 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 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
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.
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 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 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 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 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
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.
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 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
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.

Trial Locations

Locations (1)

University of Eastern Finland; 🇫🇮 Kuopio, Finland