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Completed

NCT Number: NCT04134871

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louth Meath Midlands HSE, Dundalk, Louth, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group walk and one to one coaching

Behavioral

Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Registry information

Official study title

Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness

Acronym: WORtH

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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