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HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336946
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Ghent

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.


Condition or disease Intervention/treatment Phase
Unhealthy Lifestyle of Persons With Mental Disorders Behavioral: Psycho educational and behavioural group sessions Behavioral: Walking session Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 742 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. change in body weight 10 weeks post-intervention [ Time Frame: after 10 weeks ]
    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.

  2. change in body weight 26 weeks post-intervention [ Time Frame: after 26 weeks ]
    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 :
  1. Body Mass Index 10 weeks post-intervention [ Time Frame: after 10 weeks ]
    Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²)

  2. Body Mass Index, 26 weeks post-intervention [ Time Frame: after 26 weeks ]
    Body Mass Index, calculated as the weight in kilograms divided by the square of the height in metres (kg/m²).

  3. Waist circumference, 10 weeks post-intervention [ Time Frame: After 10 weeks ]
    Waist circumference, assessed by using a tape measure.

  4. Waist circumference, 26 weeks post-intervention [ Time Frame: After 26 weeks ]
    Waist circumference, assessed by using a tape measure.

  5. Quality of Life, 10 weeks post-intervention [ Time Frame: After 10 weeks ]
    Quality of life, assessed by using the SF-36 Health Survey.

  6. Quality of Life, 26 weeks post-intervention [ Time Frame: After 26 weeks ]
    Quality of life, assessed by using the SF-36 Health Survey.

  7. Levels of physical activity, 10 weeks post-intervention [ Time Frame: After 10 weeks ]
    Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.

  8. Levels of physical activity, 26 weeks post-intervention [ Time Frame: After 26 weeks ]
    Levels of physical activity, assessed by using the International Physical Activity Questionnaire long version (IPAQ) and by using pedometers.

  9. Eating habits, 10 weeks post-intervention [ Time Frame: After 10 weeks ]
    Eating habits, assessed by using a 24-hour dietary recall.

  10. Eating habits, 26 weeks post-intervention [ Time Frame: After 26 weeks ]
    Eating habits, assessed by using a 24-hour dietary recall.

  11. Psychiatric symptom severity, 10 weeks post-intervention [ Time Frame: After 10 weeks ]
    Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).

  12. Psychiatric symptom severity, 26 weeks post-intervention [ Time Frame: After 26 weeks ]
    Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336946


Locations
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Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Lieven Annemans, Ph.D., Professor University Ghent
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01336946    
Other Study ID Numbers: EC/2010/607
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by University Ghent:
lifestyle
mental disorder
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders