- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Oulu, Finlandia, 90220
- Oulu University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- BMI 27-35
Exclusion Criteria:
- Other concurrent weight loss programs
- Disease which prevents weight loss
- Medication which affects on weight loss
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Weight change
Lasso di tempo: Baseline, 1 and 2 years
|
Baseline, 1 and 2 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in eating behavior
Lasso di tempo: Baseline, 1 and 2 years
|
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
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Baseline, 1 and 2 years
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in metabolic syndrome related blood measures
Lasso di tempo: Baseline, 1 and 2 years
|
total cholesterol, HDL, LDL, Triglycerides, glucose, blood pressure
|
Baseline, 1 and 2 years
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 55/2012
- 083/THL/TE/2012 (Altro numero di sovvenzione/finanziamento: The institute of health and welfare, Finland)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .