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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22581937
Enrollment
104
Registered
2010-10-27
Start date
2009-06-01
Completion date
Unknown
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Mental Health Research Network

Interventions

Increasing activity and improving diet. Follow up length: 12 months Study entry: Single Randomisation only

Sponsors

Lancashire Care NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Body Mass Index (BMI)

Secondary

MeasureTime frame
1. 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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026