The HELPER programme (Healthy Living and Prevention of Early Relapse): Phase 2: INTERACT
| ISRCTN | ISRCTN22581937 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22581937 |
| Protocol serial number | 5215 |
| Sponsor | Lancashire Care NHS Foundation Trust (UK) |
| Funder | National Insititue for Health Research (NIHR) (UK) |
- Submission date
- 27/10/2010
- Registration date
- 27/10/2010
- Last edited
- 11/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Louise Worrell
Scientific
Scientific
Lancashire Care NHS Foundation Trust
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
| louise.worrell@lancashirecare.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The HELPER programme (Healthy Living and Prevention of Early Relapse): Phase 2: INTERACT |
| Study acronym | HELPER (INTERACT) |
| Study objectives | Our phase 1 work has led us to develop a 12mth healthy living intervention for patients who have experienced their 1st episode of psychosis in the past 3yrs, who are attending the early intervention service, & who have a BMI of > 25 (24 for people of South Asian origin. The intervention will focus on increasing activity and improving diet. As of 15/11/2011 this study is in follow-up and the anticipated end date has been updated. The previous end date was 01/12/2010. |
| Ethics approval(s) | MREC approved (ref: 09/H1016/20) |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis |
| Intervention | Increasing activity and improving diet. Follow up length: 12 months Study entry: Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure(s) |
Body Mass Index (BMI) |
| Key secondary outcome measure(s) |
1. Adherence to medication (Brief Adherence Rating Scale) |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 104 |
| Key inclusion criteria | 1. Aged 16 - 35 years, either sex 2. Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief reactive psychosis, or psychosis not otherwise specified, determined using a checklist of criteria and review of case notes. 3. First episode of psychosis occurred within 3 years preceding the trial 4. Current user of an early intervention service 5. Have stable accommodation (i.e. not street homeless or roofless) 6. Able to give informed consent 7. Have a body mass index (BMI) of greater than 25 kg/m2, or a BMI of greater than 24 kg/m2 for service users from the South Asian community |
| Key exclusion criteria | 1. Diagnosis of substance dependence or abuse as determined from a review of case notes. Sub-diagnostic levels of substance use or abuse will not exclude people from the trial. 2. Have a significant history of organic factors implicated in the aetiology of psychotic symptoms |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Lancashire Care NHS Foundation Trust
Preston
PR5 6AW
United Kingdom
PR5 6AW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2014 | Yes | No | |
| Results article | results | 25/04/2018 | Yes | No |
Editorial Notes
11/02/2019: Publication reference added.
