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STOP DIABETES - Knowledge-based Solutions (StopDia)

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ClinicalTrials.gov Identifier: NCT03156478
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Life Style Diet Habit Physical Activity Empowerment Behavioral: Digital lifestyle intervention group Behavioral: Combined digital and face-to-face lifestyle intervention group Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: STOP DIABETES - Knowledge-based Solutions
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2037

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
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.
Experimental: 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 participantʼs 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.
Behavioral: Digital lifestyle intervention group
Intervention with digital application for lifestyle changes

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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 ]
    Assessed with validated guidelines for the measure

  2. 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 ]
    Assessed in the 2 hour oral glucose tolerance tests

  3. 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 ]
    Assessed from fasting blood sample

  4. 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 ]
    Plasma total, HDL and LDL cholesterol, and triglyceride concentrations are measured.

  5. 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. ]
    Resting systolic and diastolic blood pressure is measured by automatic sphygmomanometer in sitting position.

  6. 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. ]
    Serum high-sensitivity C-reactive protein (hs-CRP) and interleukine-1Ra (IL-1Ra) are measured as biomarkers of inflammation.

  7. 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. ]
    Plasma aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are measured as biomarkers of liver function.

  8. 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 ]
    Metabolites and metabolic profiles related to diet, other lifestyle factors and predicting type 2 diabetes measured from serum and plasma samples

  9. 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 sedentary behavior is described as the total amount spent in sitting and lying position during waking hours, and is assessed by the questionnaire.

  10. 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 ]
    Formulated according to sleeping behavior questionnaire

  11. 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 ]
    Assessed by questionnaire

  12. 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 ]
    Assessed by food frequency questionnaire

  13. 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 ]
    Eating behavior is assessed by questionnaires.

  14. 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 mental wellbeing is assessed by questionnaire.

  15. 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. ]
    Quality of life is assessed by questionnaire.

  16. 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 ]
    Use of health-care services are assessed by questionnaire and registers. Associated costs are calculated based on these data.

  17. 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. ]
    Work ability is assessed by questionnaire. Associated costs are calculated based on these data.

  18. User experience of the Internet intervention [ Time Frame: During the intervention at the time point of two weeks, and at one year follow-up ]
    Measured by the questionnaires.

  19. 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 ]
    Measured by the log data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156478


Contacts
Contact: Jussi Pihlajamäki, MD, PhD +358 50 344 0187 jussi.pihlajamaki@uef.fi
Contact: Timo A Lakka, MD, PhD +358 40 7707 329 timo.lakka@uef.fi

Locations
Finland
University of Eastern Finland Recruiting
Kuopio, Finland
Contact: Jussi Pihlajamäki, MD, PhD    +358 50 344 0187    jussi.pihlajamaki@uef.fi   
Sponsors and Collaborators
University of Eastern Finland
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
Investigators
Principal Investigator: Jussi Pihlajamäki, MD, PhD University of Eastern Finland

Additional Information:
Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03156478     History of Changes
Other Study ID Numbers: 467/2016
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Eastern Finland:
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pharmaceutical Solutions