The HELPER programme (Healthy Living and Prevention of Early Relapse): Phase 2: INTERACT

ISRCTN ISRCTN22581937
DOI https://doi.org/10.1186/ISRCTN22581937
Secondary identifying numbers 5215
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

Lancashire Care NHS Foundation Trust
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom

Email louise.worrell@lancashirecare.nhs.uk

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe HELPER programme (Healthy Living and Prevention of Early Relapse): Phase 2: INTERACT
Study acronymHELPER (INTERACT)
Study objectivesOur 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) studiedTopic: Mental Health Research Network; Subtopic: Psychosis; Disease: Psychosis
InterventionIncreasing activity and improving diet.

Follow up length: 12 months
Study entry: Single Randomisation only
Intervention typeOther
Primary outcome measureBody Mass Index (BMI)
Secondary outcome measures1. Adherence to medication (Brief Adherence Rating Scale)
2. Depression (Calgary Depression Scale)
3. Health status (36-item short form health survey [SF-36])
4. Level of daily activity (short form International Physical Activity Questionnaire)
5. Quality of life (EQ-5D)
6. The Illness Perceptions Questionnaire for Schizophrenia (IPQ-S)
7. Waist-circumference
Overall study start date01/06/2009
Completion date30/04/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 104; UK sample size: 104
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2009
Date of final enrolment30/04/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Lancashire Care NHS Foundation Trust
Preston
PR5 6AW
United Kingdom

Sponsor information

Lancashire Care NHS Foundation Trust (UK)
Hospital/treatment centre

Sceptre Point
Sceptre Way
Walton Summit
Preston
PR5 6AW
England
United Kingdom

Website http://www.lancashirecare.nhs.uk/index.php
ROR logo "ROR" https://ror.org/03zefc030

Funders

Funder type

Government

National Insititue for Health Research (NIHR) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.