NCT00350311

Brief Summary

This study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

1.2 years

First QC Date

July 6, 2006

Last Update Submit

September 25, 2008

Conditions

Psychotic DisorderObesityBehavior, Addictive

Outcome Measures

Primary Outcomes (2)

  • Smoking Cessation

  • Body Mass Index

Interventions

nicotine transdermal patch/lozengeDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • yrs
  • DSM-IV diagnosis of non-organic psychotic illness
  • Obesity (BMI \> 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present
  • Current smoker ( \> 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate

You may not qualify if:

  • Medical contraindication to exercise or use of the nicotine patch
  • Intellectual disability that would significantly impair ability to participate in the program
  • Inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre for Mental Health Studies, Univeristy Of Newcastle

Newcastle, New South Wales, 2308, Australia

Location

School of Public Health and Community Medicine, University of New South Wales

Sydney, New South Wales, 2052, Australia

Location

Department of Psychiatry, Monash University, The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Psychotic DisordersObesityBehavior, Addictive

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Amanda Baker, Assoc Prof

    Centre for Mental Health Studies, Uni of Newcastle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

February 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

AU(4)