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Effectiveness of a Lifestyle Intervention, for People With SMI Who Meet Metabolic Syndrome Criteria

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03292042
Enrollment
61
Registered
2017-09-25
Start date
2017-09-01
Completion date
2019-02-02
Last updated
2019-02-28

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

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome, lifestyle intervention, health promotion, mental health nurse, serious mental illness

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.

Interventions

BEHAVIORALPhysical health promotion program

The program has 24 sessions. Each session has two parts: * first part: half an hour of theoretical content, about the Metabolic syndrome, the effect of unhealthy lifestyle, toxic habits such as smoking or drinking alcohol, dietary habits or physical activity. * Second part: 1 hour of physical activity (walk)

Sponsors

University of Barcelona
CollaboratorOTHER
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease of at least 3 of the 5 criteria of metabolic syndrome6 monthsFasting 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

MeasureTime frameDescription
Metabolic syndrome prevalence6 monthsexpressed as a percentage
use of antipsychotic6 monthsPercentage of drugs prescribed by generic name
Toxic habits6 monthsPercentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse
Quality of life improvement6 monthsEuroQol- 5 Dimension (EQ-5D) includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026