HEalth Promotion Intervention in MEntal Health Care (HEPIMEC)

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

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.

Study Overview

• Status: Completed
• Conditions: Unhealthy Lifestyle of Persons With Mental Disorders
• Intervention / Treatment: Behavioral: Psycho educational and behavioural group sessions; Behavioral: Walking session

• Study Type: Interventional
• Enrollment (Actual): 742
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Beschut Wonen Antwerpen
  • Antwerpen, Belgium
    • Beschut Wonen Min
  • Beernem, Belgium
    • Beschut Wonen Beernem
  • Beigem, Belgium
    • Beschut Wonen De Raster
  • Blankenberge, Belgium
    • Beschut Wonen Oostkust
  • Brugge, Belgium
    • Beschut Wonen Brugge
  • Diest, Belgium
    • Beschut Wonen De Linde
  • Eeklo, Belgium
    • Beschut Wonen De Wende
  • Gent, Belgium
    • Beschut Wonen Centrum Onderweg
  • Gent, Belgium
    • Beschut Wonen Delta Wonen
  • Gent, Belgium
    • Beschut Wonen Domos
  • Gent, Belgium
    • Beschut Wonen Zagan
  • Hasselt, Belgium
    • Beschut Wonen Basis
  • Heusden-Zolder, Belgium
    • Beschut Wonen West-Limburg
  • Izegem, Belgium
    • Beschut Wonen regio Izegem
  • Kortrijk, Belgium
    • Beschut Wonen De Bolster
  • Leuven, Belgium
    • Beschut Wonen De Hulster
  • Maasmechelen, Belgium
    • Beschut Wonen Het Veer
  • Menen, Belgium
    • Beschut Wonen Eigen Woonst
  • Oostende, Belgium
    • Beschut Wonen Oostende
  • Overpelt, Belgium
    • Beschut Wonen Noord-Limburg
  • Roeselare, Belgium
    • Beschut Wonen Roeselare-Tielt
  • Sint-Niklaas, Belgium
    • Beschut Wonen Pro Mente
  • Sint-Niklaas, Belgium
    • Beschut Wonen Waasland
  • Veurne, Belgium
    • Beschut Wonen Veurne-Diksmuide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Waist circumference, 10 weeks post-intervention	Waist circumference, assessed by using a tape measure.	After 10 weeks
Waist circumference, 26 weeks post-intervention	Waist circumference, assessed by using a tape measure.	After 26 weeks
Quality of Life, 10 weeks post-intervention	Quality of life, assessed by using the SF-36 Health Survey.	After 10 weeks
Quality of Life, 26 weeks post-intervention	Quality of life, assessed by using the SF-36 Health Survey.	After 26 weeks
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
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
Eating habits, 10 weeks post-intervention	Eating habits, assessed by using a 24-hour dietary recall.	After 10 weeks
Eating habits, 26 weeks post-intervention	Eating habits, assessed by using a 24-hour dietary recall.	After 26 weeks
Psychiatric symptom severity, 10 weeks post-intervention	Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).	After 10 weeks
Psychiatric symptom severity, 26 weeks post-intervention	Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).	After 26 weeks

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Lieven Annemans, Ph.D., Professor, University Ghent

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: lifestyle; mental disorder
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: EC/2010/607