Recruiting

STOP DIABETES - Knowledge-based Solutions

ClinicalTrials.gov IDNCT03156478

PhaseNA

Enrollment10000

SponsorUniversity of Eastern Finland

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type2 Diabetes, Life Style, Diet Habit, Physical Activity, Empowerment

About this study

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.

Interventions

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

Primary outcomes

Change in diet (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 (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 (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 (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)

Eligibility information

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

Study locations

University of Eastern Finland, Kuopio, Finland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.