Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID03156478

STOP DIABETES - Knowledge-based Solutions to Prevent Type 2 Diabetes Using Digital and Face-to-Face Lifestyle Interventions

Led by University of Eastern Finland · Updated on 2017-05-17

10000

Participants Needed

1

Research Sites

991 weeks

Total Duration

On this page

Sponsors

U

University of Eastern Finland

Lead Sponsor

N

National Institute of Health and Welfare

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating new ways to identify people at higher risk of type 2 diabetes and help them adopt and maintain healthier lifestyles. This study combines strategies targeting both conscious decisions and automatic behaviors to improve diet, physical activity, and weight management. It also aims to understand societal challenges and supports for healthy living, involving health care, third sector, and community actors. The study will follow 10,000 adults aged 18 to 70 years at increased diabetes risk over a one-year randomized controlled trial and long-term follow-up. Participants will be randomly assigned to one of three groups: a control group receiving digital information about healthy diet and physical activity, a digital lifestyle intervention group using a specially developed self-help digital tool for 12 months, or a combined group receiving both the digital tool and six face-to-face group coaching sessions led by trained nurses. The digital intervention uses behavior models to encourage and support healthier habits. Some participants at certain workplaces will also experience environmental interventions to study combined effects. During the study, participants will have assessments including body measurements, blood pressure, blood tests, and a 2-hour oral glucose tolerance test at the start and after one year. They will complete detailed digital questionnaires about lifestyle, health, and well-being. Researchers will track changes in diet, physical activity, body weight, and blood glucose over one year and at multiple follow-up points up to 20 years. Additional outcomes include waist circumference, insulin levels, blood pressure, mental well-being, quality of life, and health care use. The study includes safety monitoring and long-term observation of participants.

CONDITIONS

Brief Title

STOP DIABETES - Knowledge-based Solutions

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Scoring 12 or more points on the Finnish diabetes risk score, or having previous gestational diabetes, or repeated impaired fasting glucose (6.1 - 6.9 mmol/l), or impaired glucose tolerance (7.8 - 11.0 mmol/l in oral glucose tolerance test)
  • Living in the hospital district of Northern Savo, Päijät-Häme, or South Karelia
  • Ability to use a computer, smartphone, or tablet with internet access
  • Having own personal phone number
  • Adequate Finnish language skills
Not Eligible

You will not qualify if you...

  • Diagnosed with type 1 or type 2 diabetes
  • Currently pregnant or breastfeeding
  • Current cancer or cancer treatment ended less than 6 months ago

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive lifestyle interventions to improve diet quality, physical activity, body weight, and glucose tolerance. This includes using a digital self-help tool for 12 months, with some participants also attending six face-to-face group coaching sessions.

Digital usage throughout 12 months; 6 face-to-face group coaching sessions for participants in combined intervention group

Follow-up

Duration - Up to 20 years after baseline

Participants have follow-up examinations to assess changes in health and lifestyle up to 20 years after baseline.

Visits at 1-year, 3, 5, 10, 15, and 20 years after baseline

Trial Site Locations

Total: 1 location

1

University of Eastern Finland

Kuopio, Finland

Actively Recruiting

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Research Team

J

Jussi Pihlajamäki, MD, PhD

T

Timo A Lakka, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk - A stop diabetes pragmatic randomised trial.

Timo A Lakka, Kirsikka Aittola, Elina Järvelä-Reijonen...

https://pubmed.ncbi.nlm.nih.gov/36620354

Digitally Supported Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Secondary Analysis of Long-Term User Engagement Trajectories in a Randomized Controlled Trial.

Piia Lavikainen, Elina Mattila, Pilvikki Absetz...

https://pubmed.ncbi.nlm.nih.gov/35200147

Oxygen-18 and carbon-13 isotopes in eCO2and erythrocytes carbonic anhydrase activity of Finnish prediabetic population.

Anna Kårlund, Teemu Kääriäinen, Vili M Kostamo...

https://pubmed.ncbi.nlm.nih.gov/33302264

Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

Marja Harjumaa, Pilvikki Absetz, Miikka Ermes...

https://pubmed.ncbi.nlm.nih.gov/32779571

Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial.

Jussi Pihlajamäki, Reija Männikkö, Tanja Tilles-Tirkkonen...

https://pubmed.ncbi.nlm.nih.gov/30823909