Background
Aims of the study
Methods
Study population and design
Protocol for evaluating reach: Recruitment and screening of individuals at increased risk
Recruitment and screening
Data collection at the recruitment and screening phase
Protocol for evaluating effectiveness and cost-effectiveness: The randomized controlled trial
Participants
Examination visits and randomization
Lifestyle interventions
Lifestyle target | Lifestyle recommendation |
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Diet | |
Dietary score | Improvement in diet score |
Breakfast | Have a breakfast on 5 week days |
Roots and non-root vegetables | ≥ 3 portionsa of roots and non-root vegetables per day |
Fruits and berries | ≥ 2 portionsb of fruits and berries per day |
Fish | Fish ≥2 times per week |
Red and processed meat | Red and processed meat ≤5 times per week |
Milk products | 4 portionsc of low-fat and fat-free milk, sour milk and yoghurt (≤1% fat), low-fat cheese (≤17% fat) and milk products with no or low in sugar per day |
Vegetable oils and vegetable oil based spreads | Vegetable oils and vegetable oil based spreads on bread, cooking, and in salad dressings |
Grain products | ≥6 portionsd of grain products (> 50% whole grain) per day in women and ≥ 9 portionsd per day in men |
Nuts, seeds, and almonds | About 30 g of natural nuts, seeds, and almonds per day |
Sugar containing beverages | ≤2 dl of sugar containing beverages per day |
Alcohol beverages | ≤1 portione of alcohol beverages per day in women and ≤ 2 portionse per day in men |
Physical activity | |
Physical activity | ≥30 min of at least moderate intensity physical activity per day on at least five days a week |
Sedentary behavior | Decreased sedentary behavior |
Other | |
Sleeping time | ≥7 h of sleeping per day |
Smoking | To quit or at least decrease smoking |
Body weight | Weight loss |
Mood | Increased attention to positive mood inducing factors |
Stress | Increased use of relaxation techniques |
Functionality | Content |
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Browsing habits | Users can browse and select habits in 13 lifestyle categories. |
Inspecting habits | Users can inspect the detailed description of habits, including a brief title, a short description, and a health fact. |
Selecting habits | Users can select habits to be repeated on a daily basis. |
Reporting performances | Users can report habit performances on a daily basis. |
Reflecting on own activities | Users can view a summary, including the number of selected habits and performances per 13 categories. |
Getting information on other users’ activities | Users can see a summary of other users’ habits and performances in an anonymous format in pop-up messages. |
Getting information on the prevention of type 2 diabetes | Users can read information on the prevention of type 2 diabetes. |
Getting reminders | Users receive reminders by emails and SMS messages if they do not select any habits, add any performance, start using the application within two days after the first uptake message, or use the application for seven days. |
Meeting topics | Key points |
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1. Orientation to the StopDia group coaching | Get familiar with other participants and the program Information on type 2 diabetes and lifestyle factors in its prevention |
2. Rhythm of daily life | Observation of the daily rhythms of eating habits, physical activity, sedentary behavior, stress, sleeping, and rest Tools for management of daily life Goal setting and planning: Actionable behavioral goals to improve rhythm of daily life |
3. Let’s eat well and healthy | Self-monitoring and reflection of dietary habits Principles of a healthy diet Goal setting and planning: Actionable behavioral goals for diet |
4. Enjoying physical activity | Self-monitoring and reflection of physical activity Principles of sufficient physical activity Goal setting and planning: Actionable behavioral goals for physical activity |
5. Automating activity to everyday life | How can I nudge myself to healthy lifestyle? Goal setting and planning: Actionable behavioral goals for re-designing home environment to support healthy choices |
6. Succeeding in lifestyle management, also after the StopDia study | Self-evaluating program outcomes Learning and insights for future Planning for maintenance of behavior changes |
Primary and secondary outcomes
Primary outcomes | Secondary outcomes (in more detail below and in ClinicalTials.gov. Identifier: NCT03156478) |
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Body weight | Waist circumference |
Fasting plasma glucose | Serum insulin and plasma lipids |
Two-hour plasma glucose from OGTT | Systolic and diastolic blood pressure |
Dietary score | Sedentary behavior |
Total physical activity | Psychosocial factors and mental wellbeing Use of health and social care and associated costs |