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Clinical Trials/NCT03292042
NCT03292042
Completed
Not Applicable

Impact of a Physical Health Promotion Program for People With Serious Mental Illness

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal1 site in 1 country61 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Enrollment
61
Locations
1
Primary Endpoint
Decrease of at least 3 of the 5 criteria of metabolic syndrome
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce the risk of metabolic syndrome in patients with serious mental illness who receive treatment with antipsychotic medications.

The hypothesis of the study is that: the application of a physical health promotion program in people with serious mental illness, who receive treatment with antipsychotic medications, carried out by a mental health nurse, will decrease the presence of metabolic syndrome and contribute to improve their quality of life.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
February 2, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Diagnostic of serious mental illness.
  • Treatment with antipsychotics.
  • Met at least 3 of the 5 criteria of metabolic syndrome According to the NCEP ATP III definition.

Exclusion Criteria

  • Medical contraindications to exercise
  • Admitted to hospital.
  • intellectual disability

Outcomes

Primary Outcomes

Decrease of at least 3 of the 5 criteria of metabolic syndrome

Time Frame: 6 months

Fasting glucose ≥110 mg/dL (or receiving drug therapy for hyperglycemia) Blood pressure ≥130/85 mm Hg (or receiving drug therapy for hypertension) Triglycerides ≥150 mg/dL (or receiving drug therapy for hypertriglyceridemia) HDL-C \<40 mg/dL in men or \<50 mg/dL in women (or receiving drug therapy for reduced HDL-C) Waist circumference ≥102 cm in men or ≥88 cm in women

Secondary Outcomes

  • Metabolic syndrome prevalence(6 months)
  • Quality of life improvement(6 months)
  • use of antipsychotic(6 months)
  • Toxic habits(6 months)

Study Sites (1)

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