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Promoting Physical Activity in People With Schizophrenia. (ProActiveS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514212
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
NHS Lothian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date May 2, 2018
Actual Study Start Date  ICMJE November 24, 2015
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
Feasibility and acceptability of the intervention. [ Time Frame: Post intervention (12 weeks). ]
Feasibility and acceptability of the intervention was evaluated using mixed-methods to explore recruitment, delivery, reasons for drop-out, participant feedback (positive and negative), and suggestions for improvement. This was quantitatively assessed by recording the number of eligible participants that agreed to participate and the number of participants that enrolled but dropped out. Participants were also asked to complete a feedback form, which contained space for free text, during the last session of the intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • Change in weekly step count. [ Time Frame: At baseline and at intervention end point (12 weeks). ]
    Activity was measured objectively using accelerometers.
  • Change in activity levels. [ Time Frame: Throughout the 12-week intervention. ]
    Participants used their pedometers to measure daily step count and record totals in their activity diaries. Participants also recorded sedentary time in their activity diaries.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Physical Activity in People With Schizophrenia.
Official Title  ICMJE Testing an Intervention to Increase Physical Activity in Schizophrenia: A Feasibility and Acceptability Study.
Brief Summary

People with schizophrenia die approximately 20 years earlier than those in the general population, and this is mostly due to cardiovascular disease (CVD) and related poor physical health. The risk factors for CVD are significantly more prevalent in people with schizophrenia, but they are largely preventable by, for example, engaging in regular PA. Existing interventions to increase PA in schizophrenia are generally atheoretical and lack manualisation and appropriate evaluation, thus reducing their usefulness to clinical practice.

Drawing on the MRC Guidelines for the development and evaluation of complex interventions, a 12-week intervention was developed and informed by a systematic review of the factors that influence PA in people with schizophrenia and a qualitative study exploring the barriers and motivators to PA (n=10). The feasibility and acceptability of the intervention was then investigated in an uncontrolled pilot study (n=20).

The pilot study demonstrated that the intervention was both feasible and acceptable to people with schizophrenia. The retention rate was 90% (n=18), and reasons given for dropout were work commitments and other illness.

Of the 18 who completed the intervention, 17 (94%) increased their weekly step count, 14 (78%) met current public health guidelines of 10,000 steps per day at some point during the 12 weeks, 10 (56%) experienced some weight loss, 12 (67%) took up an additional health promotion opportunity (e.g., improving diet, stopping smoking, joining a gym) and 13 (72%) took up another form of PA in addition to walking (e.g., swimming).

Participants found the intervention enjoyable and thought it should be offered to everyone with schizophrenia. The intervention also proved to be feasible and acceptable to staff who referred patients to take part. Informal feedback from staff confirmed the need for such a service, particularly for those taking anti-psychotic medication, and indicated that, if it was to be implemented more widely, it would be a popular and useful resource.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Feasibility study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Schizophrenia
Intervention  ICMJE Behavioral: ProActiveS
A 12-week behaviour change intervention, during which time participants met with the researcher weekly and used a pedometer to measure step count and completed an activity diary to monitor progress, set goals and plan how to cope with identified barriers.
Study Arms  ICMJE Experimental: ProActiveS
As this was a feasibility study, all participants received the intervention.
Intervention: Behavioral: ProActiveS
Publications * McNamee L, Mead G, MacGillivray S, Lawrie SM. Schizophrenia, poor physical health and physical activity: evidence-based interventions are required to reduce major health inequalities. Br J Psychiatry. 2013 Sep;203(3):239-41. doi: 10.1192/bjp.bp.112.125070.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of schizophrenia or related disorder (e.g., schizoaffective disorder, psychosis)
  • Living in the community
  • Clinically stable for at least 8 weeks prior to intervention enrolment
  • Ability to safely walk unaided

Exclusion Criteria:

  • Inability to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514212
Other Study ID Numbers  ICMJE 2015/0383
185550 ( Other Identifier: IRAS Project ID )
DTF/12/12 ( Other Grant/Funding Number: Chief Scientist Office )
15-SS-0192 ( Other Identifier: NHS Lothian REC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE
  • NHS Lothian
  • Chief Scientist Office of the Scottish Government
Investigators  ICMJE
Principal Investigator: Stephen M Lawrie, MBChB,FRCPsych University of Edinburgh
Principal Investigator: Gillian E Mead, MBChB,FRCPEd University of Edinburgh
PRS Account University of Edinburgh
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP