Unhealthy Lifestyle of Persons With Mental DisordersHEPIMECNCT01336946
HEalth Promotion Intervention in MEntal Health Care
A study testing Psycho educational and behavioural group sessions and Walking session in people with Unhealthy Lifestyle of Persons With Mental Disorders, run by University Ghent at 25 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unhealthy Lifestyle of Persons With Mental Disorders
- What is being tested?
- Psycho educational and behavioural group sessions and Walking session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 25 sitesBelgium
- Study dates
- Jan 2011to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- living in sheltered housing
- diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
Who cannot join
None listed.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Belgium25 sites
Beschut Wonen Antwerpen
Antwerp
Beschut Wonen Min
Antwerp
Beschut Wonen Beernem
Beernem
Beschut Wonen De Raster
Beigem
Beschut Wonen Oostkust
Blankenberge
Beschut Wonen Brugge
Bruges
Beschut Wonen De Linde
Diest
Beschut Wonen De Wende
Eeklo
Beschut Wonen Centrum Onderweg
Ghent
Beschut Wonen Delta Wonen
Ghent
Beschut Wonen Domos
Ghent
Beschut Wonen Zagan
Ghent
Beschut Wonen Basis
Hasselt
Beschut Wonen West-Limburg
Heusden-Zolder
Beschut Wonen regio Izegem
Izegem
Beschut Wonen De Bolster
Kortrijk
Beschut Wonen De Hulster
Leuven
Beschut Wonen Het Veer
Maasmechelen
Beschut Wonen Eigen Woonst
Menen
Beschut Wonen Oostende
Ostend
Beschut Wonen Noord-Limburg
Overpelt
Beschut Wonen Roeselare-Tielt
Roeselare
Beschut Wonen Pro Mente
Sint-Niklaas
Beschut Wonen Waasland
Sint-Niklaas
Beschut Wonen Veurne-Diksmuide
Veurne
About this study
Official title: 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.
- Being tested
- Psycho educational and behavioural group sessions, Walking session
- Keywords
- lifestyle, mental disorder
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho educational and behavioural group sessionsBehavioural
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...
Walking sessionBehavioural
A weekly supervised walking session (30 minutes) in a 10-week period.
| Study group | Role | What they receive |
|---|---|---|
| health promotion program | Experimental | Psycho education and behavioural group sessions and supervised walking sessions will be performed. Receives: Behavioral: Psycho educational and behavioural group sessions; Behavioral: Walking session |
| Control group | No intervention | No intervention will be performed in this control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 26 weeks
Secondary outcomes (12)
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)
Measured: 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).
Measured: after 26 weeks
Waist circumference, 10 weeks post-intervention
Waist circumference, assessed by using a tape measure.
Measured: After 10 weeks
Waist circumference, 26 weeks post-intervention
Waist circumference, assessed by using a tape measure.
Measured: After 26 weeks
Quality of Life, 10 weeks post-intervention
Quality of life, assessed by using the SF-36 Health Survey.
Measured: After 10 weeks
Quality of Life, 26 weeks post-intervention
Quality of life, assessed by using the SF-36 Health Survey.
Measured: 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.
Measured: 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.
Measured: After 26 weeks
Eating habits, 10 weeks post-intervention
Eating habits, assessed by using a 24-hour dietary recall.
Measured: After 10 weeks
Eating habits, 26 weeks post-intervention
Eating habits, assessed by using a 24-hour dietary recall.
Measured: After 26 weeks
Psychiatric symptom severity, 10 weeks post-intervention
Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
Measured: After 10 weeks
Psychiatric symptom severity, 26 weeks post-intervention
Psychiatric symptom severity, assessed by using the Brief Symptom Inventory (BSI).
Measured: After 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unhealthy Lifestyle of Persons With Mental DisordersStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven Annemans, Ph.D., Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336946
- Sponsor's protocol ID
- EC/2010/607
- Acronym
- HEPIMEC
- Status last verified
- Dec 2014
- First submitted
- 14 Apr 2011
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23855449Verhaeghe 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.
PubMed 22694796
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of a Health Promotion Intervention Targeting Physical Activity and Eating Habits in Persons With Mental Disorders
- ClinicalTrials.gov ID
- NCT01336946
- Acronym / sponsor ID
- HEPIMEC / EC/2010/607
- Keywords
- lifestyle, mental disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health promotion program | Experimental | Behavioral: Psycho educational and behavioural group sessions, Behavioral: Walking sessionPsycho education and behavioural group sessions and supervised walking sessions will be performed. |
| Control group | No intervention | –No intervention will be performed in this control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- living in sheltered housing
- diagnosed according to the Diagnostic and Statistical Manual of mental disorders (DSM-IV manual)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho educational and behavioural group sessions10 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... | Behavioural | health promotion program |
| Walking sessionA weekly supervised walking session (30 minutes) in a 10-week period. | Behavioural | health promotion program |
Primary outcome
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.
12 secondary outcomes
Body Mass Index 10 weeks post-intervention
Time frame: after 10 weeks
Body Mass Index, 26 weeks post-intervention
Time frame: after 26 weeks
Waist circumference, 10 weeks post-intervention
Time frame: After 10 weeks
Waist circumference, 26 weeks post-intervention
Time frame: After 26 weeks
Quality of Life, 10 weeks post-intervention
Time frame: After 10 weeks
Quality of Life, 26 weeks post-intervention
Time frame: After 26 weeks
Levels of physical activity, 10 weeks post-intervention
Time frame: After 10 weeks
Levels of physical activity, 26 weeks post-intervention
Time frame: After 26 weeks
Eating habits, 10 weeks post-intervention
Time frame: After 10 weeks
Eating habits, 26 weeks post-intervention
Time frame: After 26 weeks
Psychiatric symptom severity, 10 weeks post-intervention
Time frame: After 10 weeks
Psychiatric symptom severity, 26 weeks post-intervention
Time frame: After 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 23855449Verhaeghe 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.
- Derived from this study: PubMed 22694796Verhaeghe 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven Annemans, Ph.D., Professor principal investigator
University Ghent
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho educational and behavioural group sessions and Walking session in people with Unhealthy Lifestyle of Persons With Mental Disorders, run by University Ghent at 25 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body weight 10 weeks post-intervention (time frame: after 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01336946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.