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Recruiting NCT03156478

STOP DIABETES - Knowledge-based Solutions

No phase Interventional Type2 Diabetes Life Style Diet Habit Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital lifestyle intervention group, Combined digital and face-to-face lifestyle intervention group.
Who it may be relevant to
Registry conditions: Type2 Diabetes, Life Style, Diet Habit, Physical Activity. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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 outcome measures

  • Change in diet [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 outcome measures (12)
  • Change in waist circumference [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 inflammation markers [Time frame: 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 liver function [Time frame: 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 metabolite profiles [Time frame: 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 sedentary behavior [Time frame: 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 sleeping behavior [Time frame: 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 smoking behavior [Time frame: 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 alcohol consumption [Time frame: 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Finland · 1 center
  • University of Eastern Finland — Kuopio

Publications

  • Manninen S, Tilles-Tirkkonen T, Aittola K, Mannikko R, Karhunen L, Kolehmainen M, Schwab U, Lindstrom J, Lakka T, Pihlajamaki J; Stop Diabetes study group. Associations of Lifestyle Patterns with Glucose and Lipid Metabolism in Finnish Adults at Increased Risk of Type 2 Diabetes. Mol Nutr Food Res. 2024 Mar;68(5):e2300338. doi: 10.1002/mnfr.202300338. Epub 2024 Feb 2. PMID 38308150
  • 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 pragma PMID 36620354
  • 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 PMID 35200147
  • 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
  • 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
  • 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 PMID 30823909

Identifiers

NCT: NCT03156478 · 467/2016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗