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OpenTrials
Completed

NCT Number: NCT03292042

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

university hospital Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical health promotion program

Behavioral

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)

Primary outcomes

  1. 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

  1. Metabolic syndrome prevalence

    Time frame: 6 months

    expressed as a percentage

  2. use of antipsychotic

    Time frame: 6 months

    Percentage of drugs prescribed by generic name

  3. Toxic habits

    Time frame: 6 months

    Percentage of smokers percentage of people who drink alcohol percentage of people using drugs of abuse

  4. Quality of life improvement

    Time frame: 6 months

    EuroQol- 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).

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • University of Barcelona

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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