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Completed

NCT Number: NCT01336946

HEalth Promotion Intervention in MEntal Health Care

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.

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Key information

Conditions

Unhealthy Lifestyle of Persons With Mental Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beschut Wonen Antwerpen, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Psycho educational and behavioural group sessions

Behavioral

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 session

Behavioral

A weekly supervised walking session (30 minutes) in a 10-week period.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Acronym: HEPIMEC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2011
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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