Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders
GAF
1 other identifier
interventional
86
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 10, 2016
March 1, 2016
1.9 years
October 2, 2015
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in physical activity - objective
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
From baseline (T1) to 3 month after the intervention (T3)
Change in physical activity - subjective
Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)
From baseline (T1) to 3 month after the intervention (T3)
Secondary Outcomes (10)
Change in self-efficacy
From baseline (T1) to 1 week after the intervention (T2)
Change in intention for physical activity
From baseline (T1) to 1 week after the intervention (T2)
Change in self concordance of the motivation for physical activity
From baseline (T1) to 1 week after the intervention (T2)
Change in outcome expectancies for physical activity
From baseline (T1) to 1 week after the intervention (T2)
Change in planning for physical activity
From baseline (T1) to 1 week after the intervention (T2)
- +5 more secondary outcomes
Study Arms (2)
Activity Intervention
EXPERIMENTALThe 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.
Healthy Diet Intervention
ACTIVE 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindications to physical activity
- Acute suicidality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité Universitätsmedizin Berlin - Departement of Psychiatry
Berlin, State of Berlin, 10117, Germany
Related Publications (4)
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.
PMID: 11465984BACKGROUNDCraig 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.
PMID: 12900694BACKGROUNDWare 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.
PMID: 8628042BACKGROUNDWinkler 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.
PMID: 9800314BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andreas Ströhle, Prof.
Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
- PRINCIPAL INVESTIGATOR
Moritz B Petzold, Dipl.Psych.
Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dipl.Psych. Moritz Petzold
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 7, 2015
Study Start
April 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 10, 2016
Record last verified: 2016-03