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Clinical Trials/NCT01336946
NCT01336946
Completed
N/A

Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders

University Ghent25 sites in 1 country742 target enrollmentJanuary 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Unhealthy Lifestyle of Persons With Mental Disorders
Sponsor
University Ghent
Enrollment
742
Locations
25
Primary Endpoint
change in body weight 10 weeks post-intervention
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
May 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Psychiatric symptom severity, 26 weeks post-intervention(After 26 weeks)
  • Levels of physical activity, 26 weeks post-intervention(After 26 weeks)
  • Waist circumference, 10 weeks post-intervention(After 10 weeks)
  • Waist circumference, 26 weeks post-intervention(After 26 weeks)
  • Body Mass Index 10 weeks post-intervention(after 10 weeks)
  • Body Mass Index, 26 weeks post-intervention(after 26 weeks)
  • Quality of Life, 10 weeks post-intervention(After 10 weeks)
  • Quality of Life, 26 weeks post-intervention(After 26 weeks)
  • Levels of physical activity, 10 weeks post-intervention(After 10 weeks)
  • Eating habits, 10 weeks post-intervention(After 10 weeks)
  • Eating habits, 26 weeks post-intervention(After 26 weeks)
  • Psychiatric symptom severity, 10 weeks post-intervention(After 10 weeks)

Study Sites (25)

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