Clinical trial NCT01336946: HEalth Promotion Intervention in MEntal Health Care
Official title: Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unhealthy Lifestyle of Persons With Mental Disorders
Keywords: lifestyle
mental disorder
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: change in body weight 10 weeks post-intervention
timeFrame: after 10 weeks
measure: change in body weight 26 weeks post-intervention
timeFrame: after 26 weeks
Secondary outcomes:
measure: Body Mass Index 10 weeks post-intervention
timeFrame: after 10 weeks
measure: Body Mass Index, 26 weeks post-intervention
timeFrame: after 26 weeks
measure: Waist circumference, 10 weeks post-intervention
timeFrame: After 10 weeks
measure: Waist circumference, 26 weeks post-intervention
timeFrame: After 26 weeks
measure: Quality of Life, 10 weeks post-intervention
timeFrame: After 10 weeks
measure: Quality of Life, 26 weeks post-intervention
timeFrame: After 26 weeks
measure: Levels of physical activity, 10 weeks post-intervention
timeFrame: After 10 weeks
measure: Levels of physical activity, 26 weeks post-intervention
timeFrame: After 26 weeks
measure: Eating habits, 10 weeks post-intervention
timeFrame: After 10 weeks
measure: Eating habits, 26 weeks post-intervention
timeFrame: After 26 weeks
measure: Psychiatric symptom severity, 10 weeks post-intervention
timeFrame: After 10 weeks
measure: Psychiatric symptom severity, 26 weeks post-intervention
timeFrame: After 26 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Beschut Wonen Antwerpen
city: Antwerpen
country: Belgium
facility: Beschut Wonen Min
city: Beernem
country: Belgium
facility: Beschut Wonen Beernem
city: Beigem
country: Belgium
facility: Beschut Wonen De Raster
city: Blankenberge
country: Belgium
facility: Beschut Wonen Oostkust
city: Brugge
country: Belgium
facility: Beschut Wonen Brugge
city: Diest
country: Belgium
facility: Beschut Wonen De Linde
city: Eeklo
country: Belgium
facility: Beschut Wonen De Wende
city: Gent
country: Belgium
facility: Beschut Wonen Centrum Onderweg
city: Gent
country: Belgium
facility: Beschut Wonen Delta Wonen
city: Gent
country: Belgium
facility: Beschut Wonen Domos
city: Gent
country: Belgium
facility: Beschut Wonen Zagan
city: Hasselt
country: Belgium
facility: Beschut Wonen Basis
city: Heusden-Zolder
country: Belgium
facility: Beschut Wonen West-Limburg
city: Izegem
country: Belgium
facility: Beschut Wonen regio Izegem
city: Kortrijk
country: Belgium
facility: Beschut Wonen De Bolster
city: Leuven
country: Belgium
facility: Beschut Wonen De Hulster
city: Maasmechelen
country: Belgium
facility: Beschut Wonen Het Veer
city: Menen
country: Belgium
facility: Beschut Wonen Eigen Woonst
city: Oostende
country: Belgium
facility: Beschut Wonen Oostende
city: Overpelt
country: Belgium
facility: Beschut Wonen Noord-Limburg
city: Roeselare
country: Belgium
facility: Beschut Wonen Roeselare-Tielt
city: Sint-Niklaas
country: Belgium
facility: Beschut Wonen Pro Mente
city: Sint-Niklaas
country: Belgium
facility: Beschut Wonen Waasland
city: Veurne
country: Belgium
facility: Beschut Wonen Veurne-Diksmuide
Study officials:
affiliation: University Ghent
name: Lieven Annemans, Ph.D., Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.