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

ISRCTN	ISRCTN12024347
DOI	https://doi.org/10.1186/ISRCTN12024347
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	AGAUR grant number 2017 DI 55
Sponsor	Agency for Management of University and Research Grants
Funder	Agència de Gestió d'Ajuts Universitaris i de Recerca

Submission date: 07/03/2022
Registration date: 11/03/2022
Last edited: 22/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Growing evidence suggests that diet combined with a healthy lifestyle has potential for the prevention and treatment of mental illness and may modify the effects of treatments. The introduction of a diet rich in fruit and vegetables is very beneficial for health, prevents heart disease and some types of cancer, and in general is associated with a higher quality of life and good mental health⁠. The aim of this study is to determine the metabolic impact of a nutrition education program (Dietment) on metabolic parameters and the presence of metabolic syndrome. Metabolic syndrome is the medical term for a combination of diabetes, high blood pressure and obesity that increases the risk of heart disease, stroke and other conditions that affect the blood vessels.

Who can participate?
Patients over the age of 18 years with a severe mental disorder who participate actively in a community rehabilitation program

What does the study involve?
Participants are randomly allocated to the Dietment program or a control group. The Dietment program lasts 4 months (April to July 2019). It consists of a food education strategy aimed at promoting the consumption of food and vegetables and comprises 15 weekly group sessions (of 5–10 people) lasting 90 minutes each session. All sessions are conducted by the same dietitian-nutritionist. In the control group, three voluntary group sessions are offered to the participants’ relatives as support agents to facilitate the change of habits (60 minutes).

What are the possible benefits and risks of participating?
The international recommendation of five portions of food and vegetables a day has been shown to be beneficial for mental health and may offer benefits in reducing heart disease risk factors. There are no potential risks due to the intervention.

Where is the study run from?
Osona Psychopedagogical Medical Center, with the collaboration of the Vic University Hospital (Spain)

When is the study starting and how long is it expected to run for?
September 2018 to September 2020

Who is funding the study?
Agency for Management of University and Research Grants (Spain)

Who is the main contact?
Dr Quintí Foguet Boreu
42292qfb@comb.cat

Contact information

Dr Quintí Foguet-Boreu
Scientific

Department of Psychiatry, Vic University Hospital
Faculty of Medicine
University of Vic – Central University of Catalonia
Carrer Francesc Pla “El Vigatà” n1
Vic
08500
Spain

ORCID ID	0000-0002-6069-5305
Phone	+34 (0)937027772 (ext 1828)
Email	42292qfb@comb.cat

Study information

Primary study design	Interventional
Study design	Randomized community-based clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Metabolic impact of a nutrition education program for the promotion of fruit and vegetable consumption with people with severe mental disorders (DIETMENT)
Study acronym	DIETMENT
Study objectives	A food education program based on the stages of change model for severe mental disorders reduces the development of metabolic syndrome.
Ethics approval(s)	Approved 27/09/2018, the Clinical Research Ethics Committee of the Osona Foundation for Health Research and Education (FORES) (C. Francesc Pla “El Vigatà”, 1, 08500 Vic, Barcelona; +34 (0)937027710; fores@chv.cat, lsolerdelcoll@chv.cat), ref: 2018974
Health condition(s) or problem(s) studied	Metabolic syndrome
Intervention	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. The Dietment intervention program lasts 4 months (April to July 2019). It consists of a food education strategy aimed at promoting the consumption of food and vegetables and comprises 15 weekly group sessions (of 5–10 people) lasting 90 minutes each session. All sessions are conducted by the same dietitian-nutritionist. In the control group, three voluntary group sessions are offered to the participants’ relatives as support agents to facilitate the change of habits (60 minutes).
Intervention type	Behavioural
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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)]
Completion date	30/09/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	104
Total final enrolment	74
Key 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
Key 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
Date of first enrolment	08/09/2019
Date of final enrolment	30/01/2020

Locations

Countries of recruitment

Spain

Study participating centre

Osona Psychopedagogical Medical Center

C. Josep Maria Selva 2
Vic
08500
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		19/06/2021	10/03/2022	Yes	No
Results article		29/03/2022	22/05/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Thesis results		29/11/2022	10/03/2022	No	No

Editorial Notes

22/05/2023: Publication reference added.
10/03/2022: Trial's existence confirmed by the Clinical Research Ethics Committee of the Osona Foundation for Health Research and Education (FORES).