STOP DIABETES - Knowledge-based Solutions

NCT ID: NCT03156478

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2037-12-31

Brief 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.

Detailed Description

Type 2 diabetes is a major public health and economical problem all over the world, including Finland. A healthy diet and physical activity are the cornerstones for the prevention of type 2 diabetes. The aim of the Stop Diabetes - Knowledge based solutions (StopDia) study 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 recruit 10 000 individuals aged 18-70 years at increased risk of type 2 diabetes living in the hospital district of Northern Savo, Päijät-Häme, or South Karelia in Finland for a 1-year randomized controlled trial. We will assess body height and weight, body mass index, waist circumference, and blood pressure, take blood samples for biochemical analyses, and perform a 2-hour oral glucose tolerance test at baseline. The participants will be asked to fill out a detailed digital questionnaire on factors related to the risk of type 2 diabetes, including diet, physical activity, sedentary behavior, health status, physical, psychic, and social well-being, as well as the use of health care services and medications. 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. We will also investigate the effects of environmental interventions at certain workplaces and the synergistic effects of the individual level and environmental interventions in a subsample of the study population. All baseline assessments will be repeated after the 1-year follow-up. The primary outcomes will be the changes in diet, total physical activity, body weight, and plasma glucose levels from the oral glucose tolerance test. After the 1-year intervention study, follow-up examinations will be performed 3, 5, 10, 15, and 20 years after the baseline examinations.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Digital lifestyle intervention group

Intervention Type: BEHAVIORAL

Intervention with digital application for lifestyle changes

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.

Group Type: EXPERIMENTAL

Combined digital and face-to-face lifestyle intervention group

Intervention Type: BEHAVIORAL

Intervention with digital application and group meetings for lifestyle changes

Interventions

Digital lifestyle intervention group

Intervention with digital application for lifestyle changes

Intervention Type: BEHAVIORAL

Combined digital and face-to-face lifestyle intervention group

Intervention with digital application and group meetings for lifestyle changes

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Health and Welfare

UNKNOWN

Sponsor Role: collaborator

Technical Research Centre of Finland

UNKNOWN

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

University of Konstanz

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Maastricht University

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Danube-University

UNKNOWN

Sponsor Role: collaborator

Flinders University

OTHER

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Roskilde University

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

University of York

OTHER

Sponsor Role: collaborator

University of Eastern Finland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jussi Pihlajamäki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

University of Eastern Finland

Kuopio, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Jussi Pihlajamäki, MD, PhD

Role: CONTACT

jussi.pihlajamaki@uef.fi

+358 50 344 0187

Timo A Lakka, MD, PhD

Role: CONTACT

timo.lakka@uef.fi

+358 40 7707 329

Facility Contacts

Jussi Pihlajamäki, MD, PhD

Role: primary

jussi.pihlajamaki@uef.fi

+358 50 344 0187

References

Lakka TA, Aittola K, Jarvela-Reijonen E, Tilles-Tirkkonen T, Mannikko R, Lintu N, Karhunen L, Kolehmainen M, Harjumaa M, Mattila E, Jarvenpaa R, Ermes M, Mikkonen S, Martikainen J, Poutanen K, Schwab U, Absetz P, Lindstrom J, Pihlajamaki J. 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. Lancet Reg Health Eur. 2023 Jan;24:100527. doi: 10.1016/j.lanepe.2022.100527. Epub 2022 Oct 12.

Reference Type: DERIVED

PMID: 36620354 (View on PubMed)

Lavikainen P, Mattila E, Absetz P, Harjumaa M, Lindstrom J, Jarvela-Reijonen E, Aittola K, Mannikko R, Tilles-Tirkkonen T, Lintu N, Lakka T, van Gils M, Pihlajamaki J, Martikainen J. 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. J Med Internet Res. 2022 Feb 24;24(2):e31530. doi: 10.2196/31530.

Reference Type: DERIVED

PMID: 35200147 (View on PubMed)

Karlund A, Kaariainen T, Kostamo VM, Kokkola T, Kolehmainen M, Lakka TA, Pihlajamaki J, Manninen A. Oxygen-18 and carbon-13 isotopes in eCO2and erythrocytes carbonic anhydrase activity of Finnish prediabetic population. J Breath Res. 2021 Jan 22;15(2). doi: 10.1088/1752-7163/abd28d.

Reference Type: DERIVED

PMID: 33302264 (View on PubMed)

Harjumaa M, Absetz P, Ermes M, Mattila E, Mannikko R, Tilles-Tirkkonen T, Lintu N, Schwab U, Umer A, Leppanen J, Pihlajamaki J. Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial. JMIR Diabetes. 2020 Aug 11;5(3):e15219. doi: 10.2196/15219.

Reference Type: DERIVED

PMID: 32779571 (View on PubMed)

Pihlajamaki J, Mannikko R, Tilles-Tirkkonen T, Karhunen L, Kolehmainen M, Schwab U, Lintu N, Paananen J, Jarvenpaa R, Harjumaa M, Martikainen J, Kohl J, Poutanen K, Ermes M, Absetz P, Lindstrom J, Lakka TA; StopDia study group. 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. BMC Public Health. 2019 Mar 1;19(1):255. doi: 10.1186/s12889-019-6574-y.

Reference Type: DERIVED

PMID: 30823909 (View on PubMed)

Related Links

http://www.stopdia.fi/briefly-in-english

short description in English

Other Identifiers

467/2016

Identifier Type: -

Identifier Source: org_study_id