HEalth Promotion Intervention in MEntal Health Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Unhealthy Lifestyle of Persons With Mental Disorders

Intervention / Treatment
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* Behavioral: Psycho educational and behavioural group sessions
* Behavioral: Walking session


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: health promotion program<br>Psycho education and behavioural group sessions and supervised walking sessions will be performed. | Behavioral: Psycho educational and behavioural group sessions<br>* 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...<br>Behavioral: Walking session<br>* A weekly supervised walking session (30 minutes) in a 10-week period.<br>|
| No Intervention: Control group<br>No intervention will be performed in this control group. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, mental disorder