Unhealthy Lifestyle of Persons With Mental Disorders Clinical Trial
— HEPIMECOfficial title:
Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
| Verified date | December 2014 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 742 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| 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 Centrum Onderweg | Gent | |
| Belgium | Beschut Wonen Delta Wonen | Gent | |
| Belgium | Beschut Wonen Domos | Gent | |
| Belgium | Beschut Wonen Zagan | 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 Pro Mente | Sint-Niklaas | |
| Belgium | Beschut Wonen Waasland | Sint-Niklaas | |
| Belgium | Beschut Wonen Veurne-Diksmuide | Veurne |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in body weight 10 weeks post-intervention | 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. | after 10 weeks | No |
| Primary | change in body weight 26 weeks post-intervention | 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. | after 26 weeks | No |
| Secondary | Body Mass Index 10 weeks post-intervention | Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²) | after 10 weeks | No |
| Secondary | Body Mass Index, 26 weeks post-intervention | Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²). | after 26 weeks | No |
| Secondary | Waist circumference, 10 weeks post-intervention | Waist circumference, assessed by using a tape measure. | After 10 weeks | No |
| Secondary | Waist circumference, 26 weeks post-intervention | Waist circumference, assessed by using a tape measure. | After 26 weeks | No |
| Secondary | Quality of Life, 10 weeks post-intervention | Quality of life, assessed by using the SF-36 Health Survey. | After 10 weeks | No |
| Secondary | Quality of Life, 26 weeks post-intervention | Quality of life, assessed by using the SF-36 Health Survey. | After 26 weeks | No |
| Secondary | Levels of physical activity, 10 weeks post-intervention | Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers. | After 10 weeks | No |
| Secondary | Levels of physical activity, 26 weeks post-intervention | Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers. | After 26 weeks | No |
| Secondary | Eating habits, 10 weeks post-intervention | Eating habits, assessed by using a 24-hour dietary recall. | After 10 weeks | No |
| Secondary | Eating habits, 26 weeks post-intervention | Eating habits, assessed by using a 24-hour dietary recall. | After 26 weeks | No |
| Secondary | Psychiatric symptom severity, 10 weeks post-intervention | Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI). | After 10 weeks | No |
| Secondary | Psychiatric symptom severity, 26 weeks post-intervention | Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI). | After 26 weeks | No |