The feasibility of a prisoner-led intervention to reduce smoking and improve diet and physical activity amongst prisoners

ISRCTN ISRCTN15279360
DOI https://doi.org/10.1186/ISRCTN15279360
Secondary identifying numbers 3
Submission date
09/03/2017
Registration date
03/04/2017
Last edited
24/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Diseases such as cancers, cardiovascular (heart) disease and diabetes are known as ‘non-communicable diseases’ (NCDs). Cigarette smoking, unhealthy diets and lack of physical activity contribute to these conditions. NCDs are a health issue for many prisoners. There is increasing evidence that peer-based approaches in prisons can be effective in supporting healthcare delivery and health improvement amongst prisoners, many of whom struggle to trust or engage with mainstream services. The aim of this study is to investigate how a peer-led intervention might help prisoners to lead healthier lifestyles and make them less likely to suffer from NCDs.

Who can participate?
Men aged 21 and over who are in prison

What does the study involve?
The study is made up of two phases. In the first phase, the research team undertook focus groups with prisoners and interviews with staff to develop an appropriate peer-led intervention. The second phase involves delivering the peer-led intervention to test the feasibility and also whether or not the intervention leads to behaviour change (namely reductions in smoking and improvements in diet and physical activity amongst prisoners). Participants are randomly allocated to either the intervention or the control group. The peer-intervention is delivered to intervention group participants over a 6-week period and involves these participants attending weekly group sessions run by trained prisoner facilitators. Control group participants receive standard care. Smoking, diet and physical activity levels and well-being are measured using questionnaires in both groups at the start of the study, immediately after the intervention, and at 1, 3 and 6 months after the intervention. Smoking is also tested with a breath test and body mass index (BMI) is measured for each participant.

What are the possible benefits and risks of participating?
Prisoners may benefit from healthier lifestyles, and ultimately a reduction in NCDs. The research could also lead to improvements in prisoners' general health (e.g. improved emotional well-being). The peer-deliverers may also benefit from the research through gaining knowledge on health-related issues, increased employment prospects on release due to experience of working in a peer role, and the peer role may also link in with sentence planning goals. In the design of the study, every attempt has been made to minimise the intrusive nature so that it does not impose too much burden upon the participant. However, there may be a time inconvenience that inevitably accompanies participation. Inconvenience is minimised by discussing all information face-to-face so providing ample opportunity for participants to seek clarification through questioning the researcher. The study may encourage participants to undertake more physical activity as increased levels of activity is one of the aims of the intervention. Any exercise comes with risk of injury to participants. However, current health advice is that the benefits of exercise far outweigh the risks. Where appropriate, those who are particularly at risk from exercise are identified and the trialists seek review from a clinician before starting exercise. This is standard practice in research involving exercise.

Where is the study run from?
1. HMP Leeds (UK)
2. HMP Wealstun (UK)

When is the study starting and how long is it expected to run for?
March 2016 to July 2017

Who is funding the study?
Spectrum CIC (UK)

Who is the main contact?
Miss Philippa Hearty

Contact information

Miss Philippa Hearty
Scientific

Spectrum CIC
1 Navigation Walk
Wakefield
WF1 5RH
United Kingdom

ORCiD logoORCID ID 0000-0002-0172-505X

Study information

Study designMulticentre feasibility study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Prison/detention
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe feasibility of a prison-based peer-led intervention to reduce non-communicable disease risk-factors amongst prisoners
Study objectivesNo hypothesis - a feasibility study exploring the potential of peer-interventions in prisons to reduce non-communicable disease risk factors amongst prisoners
Ethics approval(s)London - South East Research Ethics Committee, 01/07/2016, ref: 16/LO/0815
Health condition(s) or problem(s) studiedNon-communicable disease risk-factors
InterventionUsing a randomised controlled design participants will be allocated 1:1 to intervention versus control arms.
The peer-intervention will be delivered to intervention arm participants over a 6-week period and will involve these participants attending weekly group sessions run by trained prisoner facilitators. Control participants will receive standard care.

The primary and secondary outcomes will be measured at baseline, immediately post-intervention, 1, 3 and 6 months post-intervention. The outcomes will be measured through self-report via a questionnaire. Self-reported smoking will be validated against participants’ objective carbon monoxide readings. BMI will also be measured for each participant.
Intervention typeBehavioural
Primary outcome measureSmoking, diet and physical activity levels, measured through self-report via a questionnaire at baseline, immediately post-intervention, 1, 3 and 6 months post-intervention
Secondary outcome measuresWell-being, measured through self-report via a questionnaire at baseline, immediately post-intervention, 1, 3 and 6 months post-intervention
Overall study start date01/03/2016
Completion date01/09/2017

Eligibility

Participant type(s)Other
Age groupAdult
SexMale
Target number of participants160
Total final enrolment80
Key inclusion criteria1. 21 years of age and over
2. If sentenced, the research participants must be in prison for the full duration of the intervention delivery
3. If remand, the research participants must be expected to be in prison for the full duration of the intervention delivery.
4. Mental capacity to provide consent to participate
Key exclusion criteria1. Those who will not be or are not expected to be in prison for the full duration of the intervention delivery
2. Those deemed not to have mental capacity to provide consent to participate
3. Those deemed to be a security risk (either to the researcher or other prisoners due to the group session nature of the intervention - this is because prison security departments will not usually authorise those prisoners deemed high risk to participate in group sessions)
4. Those unable to understand/speak English. This is because the intervention will involve the peer-deliverers communicating with the participants, and participants communicating with each other, on a regular basis through group sessions and one-to-one sessions. Due to the small scale nature of the project and limited funding, whilst the trialists would be able to provide translation facilities throughout the provision of information and consent process, they would be unable to provide appropriate translation facilities throughout the intervention delivery
5. Those with a severe life threatening physical illness that would preclude taking part in physical activity (e.g. bed bound due to terminal illness)
Date of first enrolment12/12/2016
Date of final enrolment09/01/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

HMP Leeds
Leeds
LS12 2TJ
United Kingdom
HMP Wealstun
Wetherby
LS23 7AZ
United Kingdom

Sponsor information

Spectrum CIC
Hospital/treatment centre

1 Navigation Walk
Hebble Wharf
Wakefield
WF1 5RH
England
United Kingdom

ROR logo "ROR" https://ror.org/011af0v55

Funders

Funder type

Hospital/treatment centre

Spectrum CIC

No information available

Results and Publications

Intention to publish date01/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe results of the research will be submitted to the journal 'Pilot and Feasibility Studies' for publication.
IPD sharing planThe dataset will not be made available as the trialists didn’t seek such approval when obtaining NHS REC approval. Following completion of the research, the dataset will be held for 5 years before being destroyed in a confidential manner.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

24/01/2023: The study setting has been updated from ‘Other’.
04/06/2019: The total final enrolment was added.
17/08/2018: The overall trial end date was updated from 31/07/2017 to 01/09/2017