STOP DIABETES - Knowledge-based Solutions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Eastern Finland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
type 1 or 2 diabetes
pregnancy or breastfeeding
current cancer or less than 6 months from the end of cancer treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Digital lifestyle intervention group
BehavioralIntervention with digital application for lifestyle changes
Combined digital and face-to-face lifestyle intervention group
BehavioralIntervention with digital application and group meetings for lifestyle changes
Treatment groups
10,000 Participants
are divided into 3 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Digital lifestyle intervention groupExperimental treatment 1 intervention
Group C: Combined digital and face-to-face lifestyle intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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-up2
Change in total physical activity level
Change in total physical activity level is assessed by the physical activity questionnaire.
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-up3
Change in plasma glucose levels
Assessed in the 2 hour oral glucose tolerance tests
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-up4
Change in body weight
Assessed with digital weight scales
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-upSecondary outcomes
1
Change in waist circumference
Assessed with validated guidelines for the measure
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-up2
Change in insulin concentration
Assessed in the 2 hour oral glucose tolerance tests
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-up3
Change in glycated hemoglobin
Assessed from fasting blood sample
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-up4
Change in plasma lipid concentration
Plasma total, HDL and LDL cholesterol, and triglyceride concentrations are measured.
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Eastern Finland
Lead sponsor
National Institute of Health and Welfare
Collaborator
Technical Research Centre of Finland
Collaborator
University of Melbourne
Collaborator
University of Konstanz
Collaborator
Karolinska Institutet
Collaborator
Maastricht University
Collaborator
University of Oslo
Collaborator
Danube-University
Collaborator
Flinders University
Collaborator
Cornell University
Collaborator
University of Copenhagen
Collaborator
Roskilde University
Collaborator
University of Manchester
Collaborator
University of York
Collaborator
Source ClinicalTrials.gov