Condition category
Mental and Behavioural Disorders
Date applied
27/10/2010
Date assigned
27/10/2010
Last edited
12/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Louise Worrell

ORCID ID

Contact details

Lancashire Care NHS Foundation Trust
Sceptre Way
Bamber Bridge
Preston
PR5 6AW
United Kingdom
louise.worrell@lancashirecare.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5215

Study information

Scientific title

Acronym

HELPER (INTERACT)

Study hypothesis

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

MREC approved (ref: 09/H1016/20)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase II

Drug names

Primary outcome measures

Body Mass Index (BMI)

Secondary outcome measures

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

Overall trial start date

01/06/2009

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 104; UK sample size: 104

Participant 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

Recruitment start date

01/06/2009

Recruitment end date

30/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lancashire Care NHS Foundation Trust
Preston
PR5 6AW
United Kingdom

Sponsor information

Organisation

Lancashire Care NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.lancashirecare.nhs.uk/index.php

Funders

Funder type

Government

Funder name

National Insititue for Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24500028

Publication citations

  1. Results

    Lovell K, Wearden A, Bradshaw T, Tomenson B, Pedley R, Davies LM, Husain N, Woodham A, Escott D, Swarbrick CM, Femi-Ajao O, Warburton J, Marshall M, An exploratory randomized controlled study of a healthy living intervention in early intervention services for psychosis: the INTERvention to encourage ACTivity, improve diet, and reduce weight gain (INTERACT) study., J Clin Psychiatry, 2014, 75, 5, 498-505, doi: 10.4088/JCP.13m08503.

Additional files

Editorial Notes