Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Walking for Health: an Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With SMI (WORtH)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134871
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Ulster

Brief Summary:

People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active.

A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them.

The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.


Condition or disease Intervention/treatment Phase
Mental Illness Schizophrenia Bipolar Disorder Major Depression Psychosis Behavioral: Group walk and one to one coaching Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness
Actual Study Start Date : August 22, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Participants randomised to the intervention group will be invited to attend a group education session where they will be given a step counter and activity diary, they will be invited to weekly group walks and fortnightly coaching 1-1 sessions aimed at setting and reviewing goals to increase physical activity and reduce sedentary behaviour
Behavioral: Group walk and one to one coaching
Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions

No Intervention: Control group
Participants randomised to the control group will be given an information leaflet about being more active during a one-off 1-1 consultation.



Primary Outcome Measures :
  1. Study recruitment rate [ Time Frame: Through study completion, approx. 18 months ]
    The number of participants recruited to the study in relation to the number of individuals screened along with reasons for exclusion.

  2. Retention of study participants [ Time Frame: Through study completion, approx. 18 months ]
    The number of participants that complete the study intervention versus the number of dropouts will be analysed along with reasons for drop out.

  3. Level of acceptability assessed by semi-structured interviews [ Time Frame: Data will be collected from participants at completion of the intervention, approx 3 months. ]
    Semi-structured interviews will involve gaining information on participants' level of overall satisfaction with the intervention


Secondary Outcome Measures :
  1. Change in activity levels [ Time Frame: Data will be collected at baseline and at completion of intervention, approx 3 months. ]
    Participants' activity levels will be measured at baseline and end of intervention

  2. Change in body weight (kilograms) [ Time Frame: Data will be collected at baseline and at completion of intervention, approx 3 months. ]
    Participants' body weight will be measured at baseline and end of intervention

  3. Change in waist circumference (cm) [ Time Frame: Data will be collected at baseline and at completion of intervention, approx 3 months. ]
    Participants' waist circumference will be measured at baseline and end of intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inactive adults (Male or Female; aged ≥18 years)
  • Diagnosis of any SMI (schizophrenia, psychosis, bipolar disorder and major depression).

Exclusion Criteria:

  • Significant movement impairment
  • Identified as 'Active' using the GPPAQ screening tool
  • Unable to understand English or lack comprehension to understand the purpose of the study and given written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134871


Contacts
Layout table for location contacts
Contact: Sarah C Howes, PhD +442895367226 s.howes@ulster.ac.uk
Contact: Suzanne M McDonough, PhD +35314022396 suzannemcdonough@rcsi.ie

Locations
Layout table for location information
Ireland
Louth Meath Midlands HSE Recruiting
Dundalk, Louth, Ireland
Contact: C McDonough, MD         
Contact: M Dillon         
United Kingdom
Western HSCT Not yet recruiting
Omagh, Tyrone, United Kingdom
Contact: J Brady, MD         
Northern HSCT Not yet recruiting
Antrim, United Kingdom
Contact: J McAuley, MD         
Sponsors and Collaborators
University of Ulster
Investigators
Layout table for investigator information
Principal Investigator: Suzanne M McDonough, PhD Ulster University
Layout table for additonal information
Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT04134871    
Other Study ID Numbers: 17/0078
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Bipolar Disorder
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders