Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03156478

STOP DIABETES - Knowledge-based Solutions

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital lifestyle intervention group

Behavioral

Intervention with digital application for lifestyle changes

Combined digital and face-to-face lifestyle intervention group

Behavioral

Intervention with digital application and group meetings for lifestyle changes

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jussi Pihlajamäki, MD, PhD

CONTACT

[email protected]

+358 50 344 0187

Timo A Lakka, MD, PhD

CONTACT

[email protected]

+358 40 7707 329

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • 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

Registry information

Acronym: StopDia

Important dates

Study start
2017
Primary completion
2018
Study completion
2037
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.