- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Oulu, Finland, 90220
- Oulu University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- BMI 27-35
Exclusion Criteria:
- Other concurrent weight loss programs
- Disease which prevents weight loss
- Medication which affects on weight loss
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
Andre navne:
|
Eksperimentel: 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.
Andre navne:
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Weight change
Tidsramme: Baseline, 1 and 2 years
|
Baseline, 1 and 2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in eating behavior
Tidsramme: Baseline, 1 and 2 years
|
emotional eating, uncontrolled eating, cognitive restraint, binge eating symptoms
|
Baseline, 1 and 2 years
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in metabolic syndrome related blood measures
Tidsramme: Baseline, 1 and 2 years
|
total cholesterol, HDL, LDL, Triglycerides, glucose, blood pressure
|
Baseline, 1 and 2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 55/2012
- 083/THL/TE/2012 (Andet bevillings-/finansieringsnummer: The institute of health and welfare, Finland)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Weight loss counseling program
-
Northwestern UniversityGeorgetown UniversityTilmelding efter invitationKroniske nyresygdomme | Genetisk dispositionForenede Stater
-
University of California, San FranciscoTrukket tilbageSygelig fedmeForenede Stater
-
ReShape LifesciencesAktiv, ikke rekrutterendeFedme, sygeligForenede Stater
-
University of RochesterAfsluttetFedme | OvervægtigForenede Stater
-
Noom Inc.AfsluttetVægttab | Opførsel, sundhedForenede Stater
-
Duke UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases...Afsluttet
-
School of Health Sciences GenevaAfsluttet
-
Medical University of South CarolinaWeight Watchers InternationalAfsluttetFedme | Overvægtig | Type 2 diabetesForenede Stater
-
The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalAfsluttet
-
Noom Inc.Arizona Liver HealthAfsluttetFed lever | Vægttab | NAFLD | NASHForenede Stater