Prevention of the Metabolic Syndrome by a Lifestyle Intervention - an Application of the New Intervention Methods in the Primary Health Care.

The research objectives of this study: 1) to find the best counseling methods for improving eating behavior (group counseling, tailored web-based counseling), 2) to find the predictors of successful lifestyle changes and weight loss, 3) to find the associations with biological and psychological eating behavior regulation system, 4) to study the long-term effects of the intervention, 5) to investigate the changes to the medications after the intervention . The study hypothesis is that new theoretically valid cognitive-behavioral-therapy -based counseling methods in combination with ICT support based on persuasive design improve eating behavior, weight loss and self-efficacy and reduce risk factors for the metabolic syndrome, type 2 diabetes, coronary heart disease and musculoskeletal factors.

The study population consists of participants with overweight or obesity and at least one risk factor of metabolic syndrome (MetSyn). A population-based sample of 600 participants living in the Oulu area (approx. 200 000 habitants) is collected with the help of the Finnish Population Register Centre.

Inclusion criteria include also the ability to use basic ICT technology (email etc.). Exclusion criteria are certain uncontrolled health factors, such as abnormal laboratory values (thyroid, kidney and liver function tests) or clinically significant illness with contraindication for weight loss or physical activity.

Study visits are at baseline, 1, 2 and 5 years. At the study visit blood samples are drawn at the research laboratory of the Oulu University Hospital. Along with the timeline of the visits the eating behaviour factors (emotional eating, uncontrolled eating and cognitive restraint), health information literacy (HIL), nutrition habits, smoking, alcohol consumption, medication and previous diseases are recorded by a detailed questionnaires sent to study persons by e-mail. The blood pressure, waist diameter, height and weight are also measured during the visit. All the operations have been described in detail and accepted by the regional Ethics Committee of the Northern Ostrobothnia.

The randomization process is two-phased. First the subjects who are included in the study are randomized into 2 different kinds of lifestyle face-to-face counselling groups and one control group. After that they are randomized into users or non-users of the web-based ICT-program "Onnikka". As a summary, there are six different counselling groups: 1) Intensive group counselling, 2) Intensive group counselling with Onnikka, 3) Short term group counselling, 4) Short term counselling with Onnikka, 5) Control group (no intervention at all), and 6) Only Onnikka.