- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01959763
Prevention of the Metabolic Syndrome by New Lifestyle Intervention Methods (PrevMetSyn)
Prevention of the Metabolic Syndrome by a Lifestyle Intervention - an Application of the New Intervention Methods in the Primary Health Care.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Oulu, Finland, 90220
- Oulu University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- BMI 27-35
Exclusion Criteria:
- Other concurrent weight loss programs
- Disease which prevents weight loss
- Medication which affects on weight loss
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: weight loss counseling
Cognitive behavioral therapy-based weight loss counseling program including 8 group visits
|
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.
Andra namn:
|
Experimentell: ELVIRA-based weight loss counseling
Weight loss counseling program based on 2 group visits of ELVIRA counseling method
|
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.
Andra namn:
|
Experimentell: ICT-based weight loss counseling
ICT-based weight loss counseling program with 52 weekly tasks and information packages.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Weight change
Tidsram: Baseline, 1 and 2 years
|
Baseline, 1 and 2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in eating behavior
Tidsram: Baseline, 1 and 2 years
|
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
|
Baseline, 1 and 2 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in metabolic syndrome related blood measures
Tidsram: Baseline, 1 and 2 years
|
total cholesterol, HDL, LDL, Triglycerides, glucose, blood pressure
|
Baseline, 1 and 2 years
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 55/2012
- 083/THL/TE/2012 (Annat bidrag/finansieringsnummer: The institute of health and welfare, Finland)
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