HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)
4. desember 2014 oppdatert av: University Ghent
Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
Overweight and obesity have become a serious global public health problem and the prevalence of these conditions is even higher among persons with mental disorders, compared with the general population. Overweight and obesity are partially associated with sedentary lifestyles and unhealthy eating habits.
The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and eating habits in persons with mental disorders.
The study hypothesis is that between baseline and the end of the intervention, and after a 6-month follow up period, significant differences in the primary and secondary outcomes between the intervention and control group will be identified. The investigators also hypothesize that the health promotion intervention will be cost-effective.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
742
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Antwerpen, Belgia
- Beschut Wonen Antwerpen
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Antwerpen, Belgia
- Beschut Wonen Min
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Beernem, Belgia
- Beschut Wonen Beernem
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Beigem, Belgia
- Beschut Wonen De Raster
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Blankenberge, Belgia
- Beschut Wonen Oostkust
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Brugge, Belgia
- Beschut Wonen Brugge
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Diest, Belgia
- Beschut Wonen De Linde
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Eeklo, Belgia
- Beschut Wonen De Wende
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Gent, Belgia
- Beschut Wonen Centrum Onderweg
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Gent, Belgia
- Beschut Wonen Delta Wonen
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Gent, Belgia
- Beschut Wonen Domos
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Gent, Belgia
- Beschut Wonen Zagan
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Hasselt, Belgia
- Beschut Wonen Basis
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Heusden-Zolder, Belgia
- Beschut Wonen West-Limburg
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Izegem, Belgia
- Beschut Wonen regio Izegem
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Kortrijk, Belgia
- Beschut Wonen De Bolster
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Leuven, Belgia
- Beschut Wonen De Hulster
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Maasmechelen, Belgia
- Beschut Wonen Het Veer
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Menen, Belgia
- Beschut Wonen Eigen Woonst
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Oostende, Belgia
- Beschut Wonen Oostende
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Overpelt, Belgia
- Beschut Wonen Noord-Limburg
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Roeselare, Belgia
- Beschut Wonen Roeselare-Tielt
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Sint-Niklaas, Belgia
- Beschut Wonen Pro Mente
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Sint-Niklaas, Belgia
- Beschut Wonen Waasland
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Veurne, Belgia
- Beschut Wonen Veurne-Diksmuide
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- living in sheltered housing
- diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: health promotion program
Psycho education and behavioural group sessions and supervised walking sessions will be performed.
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10 psycho educational and behavioural group sessions on topics like the Food Triangle, healthy eating, the importance of physical activity, healthy eating on a limited budget, implementing physical activity into the daily life, the influence of advertisements...
A weekly supervised walking session (30 minutes) in a 10-week period.
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Ingen inngripen: Control group
No intervention will be performed in this control group.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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change in body weight 10 weeks post-intervention
Tidsramme: after 10 weeks
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The primary outcome of the study consists of changes in body weight between baseline and 10-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
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after 10 weeks
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change in body weight 26 weeks post-intervention
Tidsramme: after 26 weeks
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The primary outcome of the study consists of changes in body weight between baseline and 26-weeks post-intervention in the intervention and control group separately and between the intervention and the control group.The participants will be weighed in light clothing without shoes, with standardised measurement.
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after 26 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Body Mass Index 10 weeks post-intervention
Tidsramme: after 10 weeks
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Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)
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after 10 weeks
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Body Mass Index, 26 weeks post-intervention
Tidsramme: after 26 weeks
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Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).
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after 26 weeks
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Waist circumference, 10 weeks post-intervention
Tidsramme: After 10 weeks
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Waist circumference, assessed by using a tape measure.
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After 10 weeks
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Waist circumference, 26 weeks post-intervention
Tidsramme: After 26 weeks
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Waist circumference, assessed by using a tape measure.
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After 26 weeks
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Quality of Life, 10 weeks post-intervention
Tidsramme: After 10 weeks
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Quality of life, assessed by using the SF-36 Health Survey.
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After 10 weeks
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Quality of Life, 26 weeks post-intervention
Tidsramme: After 26 weeks
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Quality of life, assessed by using the SF-36 Health Survey.
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After 26 weeks
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Levels of physical activity, 10 weeks post-intervention
Tidsramme: After 10 weeks
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Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
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After 10 weeks
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Levels of physical activity, 26 weeks post-intervention
Tidsramme: After 26 weeks
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Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
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After 26 weeks
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Eating habits, 10 weeks post-intervention
Tidsramme: After 10 weeks
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Eating habits, assessed by using a 24-hour dietary recall.
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After 10 weeks
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Eating habits, 26 weeks post-intervention
Tidsramme: After 26 weeks
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Eating habits, assessed by using a 24-hour dietary recall.
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After 26 weeks
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Psychiatric symptom severity, 10 weeks post-intervention
Tidsramme: After 10 weeks
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Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
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After 10 weeks
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Psychiatric symptom severity, 26 weeks post-intervention
Tidsramme: After 26 weeks
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Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
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After 26 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Lieven Annemans, Ph.D., Professor, University Ghent
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Verhaeghe N, Clays E, Vereecken C, De Maeseneer J, Maes L, Van Heeringen C, De Bacquer D, Annemans L. Health promotion in individuals with mental disorders: a cluster preference randomized controlled trial. BMC Public Health. 2013 Jul 15;13:657. doi: 10.1186/1471-2458-13-657.
- Verhaeghe N, De Maeseneer J, Maes L, Van Heeringen C, Bogaert V, Clays E, De Bacquer D, Annemans L. Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial. BMC Public Health. 2012 Jun 13;12:431. doi: 10.1186/1471-2458-12-431.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. mai 2013
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
14. april 2011
Først innsendt som oppfylte QC-kriteriene
15. april 2011
Først lagt ut (Anslag)
18. april 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. desember 2014
Sist bekreftet
1. desember 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EC/2010/607
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .