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 |
| Secondary identifying numbers | AGAUR grant number 2017 DI 55 |
- 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
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
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) |
| 42292qfb@comb.cat |
Study information
| Study design | Randomized community-based clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 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 outcome measures | 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)] |
| Overall study start date | 27/09/2018 |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Vic
08500
Spain
Sponsor information
Government
Paseig Lluis Companys 23
Barcelona
08010
Spain
| Phone | +34 (0)93 310 63 94 |
|---|---|
| informacio.agaur@gencat.cat | |
| Website | https://agaur.gencat.cat/en/inici/index.html |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Agency for Management of University and Research Grants, Agencia de Gestión de Ayudas Universitarias y de Investigación, AGAUR
- Location
- Spain
Results and Publications
| Intention to publish date | 15/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The researchers hope to publish the article in BMC Research Notes |
| 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 | |
| Thesis results | 29/11/2022 | 10/03/2022 | No | No | |
| Results article | 29/03/2022 | 22/05/2023 | Yes | 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).
