STOP DIABETES - Knowledge-based Solutions

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03156478
• Date of registration: 13/04/2017
• Prospective Registration: No
• Primary sponsor: University of Eastern Finland
• Public title: STOP DIABETES - Knowledge-based Solutions StopDia
• Scientific title: STOP DIABETES - Knowledge-based Solutions
• Date of first enrolment: April 10, 2017
• Target sample size: 10000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03156478
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Jussi Pihlajamäki, MD, PhD
• Affiliation: University of Eastern Finland

• Name: Jussi Pihlajamäki, MD, PhD

• Name: Jussi Pihlajamäki, MD, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Life Style

Empowerment

Physical Activity

Diet Habit

Type2 Diabetes

Intervention(s)

Behavioral: Digital lifestyle intervention group

Behavioral: Combined digital and face-to-face lifestyle intervention group

Primary Outcome(s)

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 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]

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 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]

Secondary Outcome(s)

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.]

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 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]

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]

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]

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]

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.]

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.]

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]

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]

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]

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]

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.]

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.]

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]

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]

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]

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]

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

Secondary ID(s)

467/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Karolinska Institutet

Maastricht University

Roskilde University

University of Konstanz

National Institute of Health and Welfare

University of Manchester

University of Melbourne

Danube-University

Flinders University

Cornell University

University of Copenhagen

Technical Research Centre of Finland

University of Oslo

University of York