STOP DIABETES - Knowledge-based Solutions

NCT03156478 | Recruiting DMC

• 1 other identifier: 467/2016
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prevention; Digital solutions; Type 2 diabetes; Life style modification; Physical activity; Healthy diet; Health economics; Environmental choice architecture; Socio-economic facilitators; Socio-economic barriers; Wellbeing

Outcome Measures

Primary Outcomes (4)

• Change in diet

  Change in diet is assessed by the dietary score based on Finnish Nutrition Recommendations and is formulated according to food frequency questionnaire.

  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

  Change in total physical activity level is assessed by the physical activity questionnaire.

  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

  Assessed in the 2 hour oral glucose tolerance tests

  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

  Assessed with digital weight scales

  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 Outcomes (19)

• Change in waist circumference

  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

  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

  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

  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

  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.

Study Arms (3)

Control group

NO INTERVENTION

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.

Digital lifestyle intervention group

EXPERIMENTAL

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.

Behavioral: Digital lifestyle intervention group

Combined digital and face-to-face lifestyle intervention group

EXPERIMENTAL

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.

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

Interventions

Digital lifestyle intervention group BEHAVIORAL

Intervention with digital application for lifestyle changes

Digital lifestyle intervention group

Combined digital and face-to-face lifestyle intervention group BEHAVIORAL

Intervention with digital application and group meetings for lifestyle changes

Combined digital and face-to-face lifestyle intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of 18-70 years
• 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

You may not qualify if:

• type 1 or 2 diabetes
• pregnancy or breastfeeding
• current cancer or less than 6 months from the end of cancer treatment

Sponsors & Collaborators

• University of Eastern Finland: lead
• National Institute of Health and Welfare: collaborator
• Technical Research Centre of Finland: collaborator
• University of Melbourne: collaborator
• University of Konstanz: collaborator
• Karolinska Institutet: collaborator
• Maastricht University: collaborator
• University of Oslo: collaborator
• Danube-University: collaborator
• Flinders University: collaborator
• Cornell University: collaborator
• University of Copenhagen: collaborator
• Roskilde University: collaborator
• University of Manchester: collaborator
• University of York: collaborator

Study Sites (1)

University of Eastern Finland

Kuopio, Finland

RECRUITING

Related Publications (5)

• 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.

  PMID: 36620354 DERIVED

• 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.

  PMID: 35200147 DERIVED

• 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.

  PMID: 33302264 DERIVED

• 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.

  PMID: 32779571 DERIVED

• 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.

  PMID: 30823909 DERIVED

Related Links

• short description in English

MeSH Terms

Conditions

Feeding Behavior; Motor Activity; Empowerment; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Social Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jussi Pihlajamäki, MD, PhD

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi Pihlajamäki, MD, PhD

CONTACT

+358 50 344 0187; jussi.pihlajamaki@uef.fi

Timo A Lakka, MD, PhD

CONTACT

+358 40 7707 329; timo.lakka@uef.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in 3 groups: 1) control group, 2) digital lifestyle intervention group and 3) combined digital and face-to-face lifestyle intervention group. Environmental changes will be done within some work places.Part of the participants in each group may be exposed to environmental modification that are aimed for lifestyle changes at work places.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: May 17, 2017
• Study Start: April 10, 2017
• Primary Completion: December 1, 2018
• Study Completion (Estimated): December 1, 2037
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)