HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)
This study is ongoing, but not recruiting participants.
Sponsor:
University Ghent
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01336946
First received: April 14, 2011
Last updated: May 4, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Unhealthy Lifestyle of Persons With Mental Disorders |
Behavioral: Psycho educational and behavioural group sessions Behavioral: Walking session |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders |
Resource links provided by NLM:
Further study details as provided by University Ghent:
Primary Outcome Measures:
- change in body weight 10 weeks post-intervention [ Time Frame: after 10 weeks ] [ Designated as safety issue: No ]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.
- change in body weight 26 weeks post-intervention [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Body Mass Index 10 weeks post-intervention [ Time Frame: after 10 weeks ] [ Designated as safety issue: No ]Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)
- Body Mass Index, 26 weeks post-intervention [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).
- Waist circumference, 10 weeks post-intervention [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]Waist circumference, assessed by using a tape measure.
- Waist circumference, 26 weeks post-intervention [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]Waist circumference, assessed by using a tape measure.
- Quality of Life, 10 weeks post-intervention [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]Quality of life, assessed by using the SF-36 Health Survey.
- Quality of Life, 26 weeks post-intervention [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]Quality of life, assessed by using the SF-36 Health Survey.
- Levels of physical activity, 10 weeks post-intervention [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
- Levels of physical activity, 26 weeks post-intervention [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.
- Eating habits, 10 weeks post-intervention [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]Eating habits, assessed by using a 24-hour dietary recall.
- Eating habits, 26 weeks post-intervention [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]Eating habits, assessed by using a 24-hour dietary recall.
- Psychiatric symptom severity, 10 weeks post-intervention [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
- Psychiatric symptom severity, 26 weeks post-intervention [ Time Frame: After 26 weeks ] [ Designated as safety issue: No ]Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
| Enrollment: | 742 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: health promotion program
Psycho education and behavioural group sessions and supervised walking sessions will be performed.
|
Behavioral: Psycho educational and behavioural group sessions
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...
Behavioral: Walking session
A weekly supervised walking session (30 minutes) in a 10-week period.
|
|
No Intervention: Control group
No intervention will be performed in this control group.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336946
Locations
| Belgium | |
| Beschut Wonen Antwerpen | |
| Antwerpen, Belgium | |
| Beschut Wonen Min | |
| Antwerpen, Belgium | |
| Beschut Wonen Beernem | |
| Beernem, Belgium | |
| Beschut Wonen De Raster | |
| Beigem, Belgium | |
| Beschut Wonen Oostkust | |
| Blankenberge, Belgium | |
| Beschut Wonen Brugge | |
| Brugge, Belgium | |
| Beschut Wonen De Linde | |
| Diest, Belgium | |
| Beschut Wonen De Wende | |
| Eeklo, Belgium | |
| Beschut Wonen Zagan | |
| Gent, Belgium | |
| Beschut Wonen Centrum Onderweg | |
| Gent, Belgium | |
| Beschut Wonen Delta Wonen | |
| Gent, Belgium | |
| Beschut Wonen Domos | |
| Gent, Belgium | |
| Beschut Wonen Basis | |
| Hasselt, Belgium | |
| Beschut Wonen West-Limburg | |
| Heusden-Zolder, Belgium | |
| Beschut Wonen regio Izegem | |
| Izegem, Belgium | |
| Beschut Wonen De Bolster | |
| Kortrijk, Belgium | |
| Beschut Wonen De Hulster | |
| Leuven, Belgium | |
| Beschut Wonen Het Veer | |
| Maasmechelen, Belgium | |
| Beschut Wonen Eigen Woonst | |
| Menen, Belgium | |
| Beschut Wonen Oostende | |
| Oostende, Belgium | |
| Beschut Wonen Noord-Limburg | |
| Overpelt, Belgium | |
| Beschut Wonen Roeselare-Tielt | |
| Roeselare, Belgium | |
| Beschut Wonen Waasland | |
| Sint-Niklaas, Belgium | |
| Beschut Wonen Pro Mente | |
| Sint-Niklaas, Belgium | |
| Beschut Wonen Veurne-Diksmuide | |
| Veurne, Belgium | |
Sponsors and Collaborators
University Ghent
Investigators
| Principal Investigator: | Lieven Annemans, Ph.D., Professor | University Ghent |
More Information
No publications provided by University Ghent
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Ghent |
| ClinicalTrials.gov Identifier: | NCT01336946 History of Changes |
| Other Study ID Numbers: | EC/2010/607 |
| Study First Received: | April 14, 2011 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Ghent:
|
lifestyle mental disorder |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 19, 2013