HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)
4. december 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
742
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Antwerpen, Belgien
- Beschut Wonen Antwerpen
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Antwerpen, Belgien
- Beschut Wonen Min
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Beernem, Belgien
- Beschut Wonen Beernem
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Beigem, Belgien
- Beschut Wonen De Raster
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Blankenberge, Belgien
- Beschut Wonen Oostkust
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Brugge, Belgien
- Beschut Wonen Brugge
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Diest, Belgien
- Beschut Wonen De Linde
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Eeklo, Belgien
- Beschut Wonen De Wende
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Gent, Belgien
- Beschut Wonen Centrum Onderweg
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Gent, Belgien
- Beschut Wonen Delta Wonen
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Gent, Belgien
- Beschut Wonen Domos
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Gent, Belgien
- Beschut Wonen Zagan
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Hasselt, Belgien
- Beschut Wonen Basis
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Heusden-Zolder, Belgien
- Beschut Wonen West-Limburg
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Izegem, Belgien
- Beschut Wonen regio Izegem
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Kortrijk, Belgien
- Beschut Wonen De Bolster
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Leuven, Belgien
- Beschut Wonen De Hulster
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Maasmechelen, Belgien
- Beschut Wonen Het Veer
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Menen, Belgien
- Beschut Wonen Eigen Woonst
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Oostende, Belgien
- Beschut Wonen Oostende
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Overpelt, Belgien
- Beschut Wonen Noord-Limburg
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Roeselare, Belgien
- Beschut Wonen Roeselare-Tielt
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Sint-Niklaas, Belgien
- Beschut Wonen Pro Mente
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Sint-Niklaas, Belgien
- Beschut Wonen Waasland
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Veurne, Belgien
- Beschut Wonen Veurne-Diksmuide
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 indgriben: Control group
No intervention will be performed in this control group.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lieven Annemans, Ph.D., Professor, University Ghent
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
14. april 2011
Først indsendt, der opfyldte QC-kriterier
15. april 2011
Først opslået (Skøn)
18. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EC/2010/607
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 .