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Clinical Trials/ACTRN12619000723189
ACTRN12619000723189
Not Yet Recruiting
N/A

Pilot study to evaluate the effect of a lifestyle intervention: on quality of physical and mental health in people with schizophrenia treated with either clozapine or another antipsychotic medication who are overweight/obese

Hunter New England Mental Health Local health District0 sites40 target enrollmentMay 14, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Hunter New England Mental Health Local health District
Enrollment
40
Status
Not Yet Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 14, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hunter New England Mental Health Local health District

Eligibility Criteria

Inclusion Criteria

  • Age \-18\-65 years
  • Taking clozapine for at least 18 weeks and are in maintenance phase or
  • have been taking another antipsychotic medication for at least 6 months
  • Are overweight or obese – BMI greater than 25
  • Have access to transport – either by having their own car, or living in the area and near a bus stop, or have an NDIS support worker who can bring them

Exclusion Criteria

  • Women who are pregnant
  • Acutely unwell (psychotic) or an intellectual disability with severe cognitive impairment which would prevent them from participating in the behavioural program
  • Are currently taking medications that may interfere with intervention ( for example metformin, diuretics, any other weight loss medication).
  • Persons who are unable to read or write and understand the information statement, consent form, and self\-report measures are ineligible. Informed consent must be obtained to be eligible for the study. As part of the dietary intervention, participants will learn about reading labels so that the right food products can be chosen. Basic level of reading and writing is required for this research.

Outcomes

Primary Outcomes

Not specified

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