AzTrials
AzTrials

Mental DisordersPhase 2GAFNCT02569619

Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders

A Phase 2 study testing Activity Intervention and Healthy Diet Intervention in people with Mental Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if a manualised intervention to promote physical activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of everyday physical activity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Disorders
What is being tested?
Activity Intervention and Healthy Diet Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteGermany
Study dates
Apr 2014to Mar 2016
Phase
Phase 2
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

  • Over 18 years of Age
  • Patients in one of the psychiatric outpatients or at an local psychiatrist in Berlin
  • Mental illness (ICD-10: F1-F4)
  • No contraindications for physical activity
  • Able to understand german language

Who cannot join

  • Contraindications to physical activity
  • Acute suicidality

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Universitätsmedizin Berlin - Departement of Psychiatry

    Berlin, State of Berlin, 10117

Other trials in Germany

About this study

Official title: Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders: Motivational Determinants of Adherence, Effect on Cognitive Determinants of Physical Activity, Physical Activity, Sitting Time and Clinical Symptoms

The purpose of this study is to determine if a manualised intervention to promote physical activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of everyday physical activity.

Read the detailed description

The Intervention program MoVo-LISA is a psychological intervention that should help participants to increase their level of physical activity for a healthy lifestyle.It contains three sessions (2 group,1 one on one) in the course of two weeks. The intervention focuses on planning and barrier management.

Participants develop activity ideas, goals and plans that enable them to integrate physical activity in their everyday routine and how to shield their motivation against barriers and difficulties.The intervention has proven to be effective with patients with pain disorders in rehabilitation.

This study examines if the intervention if effective for psychiatric outpatients as well. The intervention is compared to an active control group that receives a similar program that is focusing on a healthy diet.

Participants are recruited in the outpatient departements of three hospitals in Berlin and Brandenburg (Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy; St. Hewdig Hospital Berlin - Departement of Psychiatry; Oberhavel Hospital Brandenburg, Departement of Psychiatry) and at local psychiatrists in Berlin. Individuals are recruited by posters and flyers in the waiting areas areas or by information of their doctor. Patients can contact the researcher and are, after checked for eligibility, invited to an information event, where they get detailed information on the program and the study. After the information event, participants give written informed consent.

The intervention takes place in the outpatient departements of the three hospitals.

Clinical information about diagnoses, medication and functioning is obtained by their doctors by mail after the patients released them from confidentiality.

The study is an explorative approach to test if the program is suited for psychiatric patients. A sample size of 50 participants that complete the program is planned.

All data is collected pseudonymised to protect the identity of the patients.

Being tested
Activity Intervention, Healthy Diet Intervention
Keywords
Physical Activity, Mental Health, Physical Exercise, Mental disorder, Promotion
Medical subject headings
Mental Disorders, Motor Activity, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Activity InterventionBehavioural

  • Healthy Diet InterventionBehavioural

Study groups in NCT02569619
Study groupRoleWhat they receive
Activity InterventionExperimentalThe activity intervention is MoVo-LISA (Göhner \& Fuchs, 2007). A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes. The patients develop aims for their health, ideas, how to reach these aims through physical activity and make detailed plans, how to implement activity in their everyday routine. Difficulties and barriers are discussed.
Receives: Behavioral: Activity Intervention
Healthy Diet InterventionActive comparatorThe healthy diet intervention is a modification of MoVo-LISA. A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes. The patients develop aims for their health, ideas, how to reach these aims through a healthy diet and make detailed plans, how to implement a healthy diet in their everyday routine. Difficulties and barriers are discussed.
Receives: Behavioral: Healthy Diet Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical activity - objective

    Physical activity is objectively measured using accelerometry (ActiGraph GT1M)

    Measured: From baseline (T1) to 3 month after the intervention (T3)

  2. Change in physical activity - subjective

    Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)

    Measured: From baseline (T1) to 3 month after the intervention (T3)

Secondary outcomes (10)

  1. Change in self-efficacy

    Self-efficacy is measured using two likert scaled items

    Measured: From baseline (T1) to 1 week after the intervention (T2)

  2. Change in intention for physical activity

    Intention for physical activity is measured using two likert scaled items

    Measured: From baseline (T1) to 1 week after the intervention (T2)

  3. Change in self concordance of the motivation for physical activity

    Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items

    Measured: From baseline (T1) to 1 week after the intervention (T2)

  4. Change in outcome expectancies for physical activity

    Outcome expectancies for physical activity are measured using 6 likert scaled items

    Measured: From baseline (T1) to 1 week after the intervention (T2)

  5. Change in planning for physical activity

    Planning for physical activity is measured using 4 likert scaled items

    Measured: From baseline (T1) to 1 week after the intervention (T2)

  6. Change in barrier planning for physical activity

    Barrier planning for physical activity is measured using 4 likert scaled items

    Measured: From baseline (T1) to 1 week after the intervention (T2)

  7. Change in psychopathological symptoms

    Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)

    Measured: From baseline (T1) to 3 month after the intervention (T3)

  8. Change in health-related quality of life

    Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)

    Measured: From baseline (T1) to 3 month after the intervention (T3)

  9. Change in dietary behavior

    Dietary behavior is measured using the Food Frequency Questionnaire (FEL)

    Measured: From baseline (T1) to 3 month after the intervention (T3)

  10. Change in consumption of portions of fruit and vegetable per day

    Consumption of fruit and vegetable is measured using two items asking for the number of portions of fruit and vegetable that are consumed on a regular day (a portion is defined as a hand full). Consumption of fruit and vegetable is then added to check if the WHO recommendation of "5 a day" is met

    Measured: From baseline (T1) to 3 month after the intervention (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569619
Sponsor's protocol ID
GAF-1
Acronym
GAF
Status last verified
Mar 2016
First submitted
2 Oct 2015
Last updated
10 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hardt J, Gerbershagen HU. Cross-validation of the SCL-27: a short psychometric screening instrument for chronic pain patients. Eur J Pain. 2001;5(2):187-97. doi: 10.1053/eujp.2001.0231.

    PubMed 11465984

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

  • Winkler G, Doring A. Validation of a short qualitative food frequency list used in several German large scale surveys. Z Ernahrungswiss. 1998 Sep;37(3):234-41. doi: 10.1007/pl00007377.

    PubMed 9800314

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Activity Intervention and Healthy Diet Intervention in people with Mental Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.

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 5 inclusion and 2 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 physical activity - objective (time frame: From baseline (T1) to 3 month after the intervention (T3)). 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 NCT02569619, which also lists 4 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 10 Mar 2016.

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