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Metabolic impact of a nutrition education program for the promotion of fruit and vegetable consumption with people with severe mental disorders

Metabolic impact of a nutrition education program for the promotion of fruit and vegetable consumption with people with severe mental disorders (DIETMENT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12024347
Enrollment
104
Registered
2022-03-11
Start date
2019-09-08
Completion date
Unknown
Last updated
2023-06-05

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

Conditions

Metabolic syndrome Nutritional, Metabolic, Endocrine

Interventions

For randomization the Zenon algorithm (equiprobable randomization 1:1 through R Software) is used, considering the variables of age, gender, functionality, and primary mental health diagnosis.

Sponsors

Agency for Management of University and Research Grants
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals over the age of 18 years with a clinical diagnosis of a severe mental disorder (SMD) who participated actively in a community rehabilitation program

Exclusion criteria

Exclusion criteria: 1. Users of the residential services 2. Substance use disorder 3. Dementia 4. Relapse of mental disorder 5. Moderate to severe intellectual development disorder 6. Individuals with a diet that contraindicates the consumption of foods and vegetables

Design outcomes

Primary

MeasureTime frame
Metabolic syndrome, defined using the following criteria: 1. Abdominal perimeter measurement of the Spanish population (94.5 cm in men and 89.5 cm for women) 2. Blood pressure (BP) >130/85 mmHg, triglyceride (TG) >150 mg/dl; glycaemia >100 mg/dl 3. HDL-cholesterol (<40 mg/dl for men and 50 mg/dl for women) Subjects prescribed medication for hypertension, dyslipidemia or impaired glucose tolerance/diabetes are considered as having the respective risk factors. For a diagnosis of MetS, at least three abnormal components are required. Measured at baseline and after a mean of 5 months post-intervention.

Secondary

MeasureTime frame
Measured at baseline and after a mean of 5 months post-intervention: 1. Glycated haemoglobin (%), total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl) and triglycerides (mg/dl) measured using blood samples 2. Body mass index (BMI) [weight (kg)/size (m²)]

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026