Prevention of the Metabolic Syndrome by New Lifestyle Intervention Methods

Study Overview
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Brief Summary
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This intervention aims to reduce obesity by using new type of nutritional and lifestyle therapy and in parallel, tailored persuasive information and communications technology (ICT)-technology based application. The study hypothesis is that obesity cannot be reduced just by distributing nutritional information. Instead, by influencing also the eating behavior, permanent lifestyle changes can be achieved. The effect of the therapy along the time-line, the health information literacy of the study persons and the changes in it will be studied at different phases of the intervention. The research will be carried out in three groups of different nutritional therapies with a parallel ICT-intervention group for each.

Detailed Description
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The research objectives of this study: i) to find the best counseling methods for improving eating behavior (group counseling, tailored web-based counseling), ii) to find the predictors of successful lifestyle changes and weight loss, iii) to find the associations with biological and psychological eating behavior regulation system. 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 subjects with overweight or obesity and at least one risk factor of metabolic syndrome (MetSyn). A population-based sample of 600 subjects 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. At the screening 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.

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

Conditions
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Metabolic Syndrome, Obesity, Overweight, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Weight loss counseling program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 27-35 Exclusion Criteria: Other concurrent weight loss programs Disease which prevents weight loss Medication which affects on weight loss

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weight loss counseling<br>Cognitive behavioral therapy-based weight loss counseling program including 8 group visits | Behavioral: Weight loss counseling program<br>* Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.<br>* Other names: PrevMetSyn, Prevent Metabolic Syndrome;|
| Experimental: ELVIRA-based weight loss counseling<br>Weight loss counseling program based on 2 group visits of ELVIRA counseling method | Behavioral: Weight loss counseling program<br>* Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.<br>* Other names: PrevMetSyn, Prevent Metabolic Syndrome;|
| Experimental: ICT-based weight loss counseling<br>ICT-based weight loss counseling program with 52 weekly tasks and information packages. | Behavioral: Weight loss counseling program<br>* Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.<br>* Other names: PrevMetSyn, Prevent Metabolic Syndrome;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | Baseline, 1 and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in eating behavior | emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms | Baseline, 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, obesity, overweight, weight loss intervention, cognitive behavioral therapy, ICT intervention, cardiovascular disease, persuasive systems design