HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Ghent.
Recruitment status was  Active, not recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014