NCT02569619

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

October 2, 2015

Last Update Submit

March 9, 2016

Conditions

Keywords

Physical ActivityMental HealthPhysical ExerciseMental disorderPromotion

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

EXPERIMENTAL

The 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.

Behavioral: Activity Intervention

Healthy Diet Intervention

ACTIVE COMPARATOR

The 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.

Behavioral: Healthy Diet Intervention

Interventions

Activity Intervention
Healthy Diet Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 11465984BACKGROUND
  • 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.

    PMID: 12900694BACKGROUND
  • 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.

    PMID: 8628042BACKGROUND
  • 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.

    PMID: 9800314BACKGROUND

Related Links

MeSH Terms

Conditions

Mental DisordersMotor ActivityPsychological Well-Being

Condition Hierarchy (Ancestors)

BehaviorPersonal Satisfaction

Study Officials

  • Andreas Ströhle, Prof.

    Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

    STUDY DIRECTOR
  • Moritz B Petzold, Dipl.Psych.

    Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

    PRINCIPAL INVESTIGATOR

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

Locations