Promoting Physical Activity in People With Schizophrenia. (ProActiveS)

• ClinicalTrials.gov Identifier: NCT03514212
• Recruitment Status: Completed
• First Posted: May 2, 2018
• Last Update Posted: May 2, 2018
• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian; Chief Scientist Office of the Scottish Government
• Information provided by (Responsible Party): University of Edinburgh

Tracking Information

• First Submitted Date: March 27, 2018
• First Posted Date: May 2, 2018
• Last Update Posted Date: May 2, 2018
• Actual Study Start Date: November 24, 2015
• Actual Primary Completion Date: August 31, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Promoting Physical Activity in People With Schizophrenia.
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Feasibility study

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Schizophrenia

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 1, 2018): 20
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 31, 2016
• Actual Primary Completion Date: August 31, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03514212
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: University of Edinburgh
• Study Sponsor: University of Edinburgh

Collaborators

• NHS Lothian
• Chief Scientist Office of the Scottish Government

Investigators

• 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