STOP DIABETES - Knowledge-based Solutions

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Finland
University of Eastern Finland
RECRUITING
Kuopio
Contact Information
Primary
Jussi Pihlajamäki, MD, PhD
jussi.pihlajamaki@uef.fi
+358 50 344 0187
Backup
Timo A Lakka, MD, PhD
timo.lakka@uef.fi
+358 40 7707 329
Time Frame
Start Date: 2017-04-10
Estimated Completion Date: 2037-12
Participants
Target number of participants: 10000
Treatments
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 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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska Institutet, University of York, Technical Research Centre of Finland, National Institute of Health and Welfare, Flinders University, University of Konstanz, University of Melbourne, Danube-University, University of Copenhagen, University of Oslo, Maastricht University, Roskilde University, University of Manchester, Cornell University
Leads: University of Eastern Finland

This content was sourced from clinicaltrials.gov