First Episode Psychosis (FEP)MetaKOPNCT06650943
Nursing Intervention in Weight and Metabolic Syndrome Management in First-episode Psychosis (MetaKOP)
A study testing Nursing Consultation in Weight Management and Metabolic syndrome in people with First Episode Psychosis (FEP) and Metabolic Syndrome X, run by Hospital de Basurto at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- First Episode Psychosis (FEP), Metabolic Syndrome X
- What is being tested?
- Nursing Consultation in Weight Management and Metabolic syndrome
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the Early Intervention Program (EIP).
- First-episode psychosis (FEP) within the last 5 years.
- Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.
Who cannot join
- Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.
- Comorbid diagnosis of neurological pathology.
- Language or comprehension impairments preventing accurate data collection.
- Use of hypoglycemic medication before or during the study.
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Basurto
Bilbao, Vizcaya, 48013
Lander Madaria, 646179740, landermadaria@gmail.com
About this study
Official title: Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. The main questions it aims to answer are:
Will the intervention lead to a clinically significant weight loss (≥5%)? Can the intervention improve metabolic parameters, psychopathological state, physical activity level, and quality of life? Researchers will compare participants receiving the specialized nursing consultations to those receiving routine care to see if the former group experiences greater improvements in weight loss and metabolic risk reduction.
Read more
Participants will:
Attend a series of 8 nursing consultations focused on dietary habits based on the carbohydrate-insulin model and physical activity.
Complete assessments at the start, 6 months, and 12 months, including weight, metabolic parameters, and psychological evaluations.
- Being tested
- Nursing Consultation in Weight Management and Metabolic syndrome
- Keywords
- FEP, psychosis, metabolic syndrome, nursing, mental health nurse
- Medical subject headings
- Metabolic Syndrome, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Consultation in Weight Management and Metabolic syndromeBehavioural
Based on the Carbohydrate-insulin Theory
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention consists of 8 nursing consultations with a mental health nurse trained in healthy habits for individuals with psychosis. During the first 2 months, 4 consultations will focus on dietary habits based on the carbohydrate-insulin theory and physical activity, following a guide developed by experts, incorporating recommendations from the American Diabetes Association. Visits 5 and 6 occur at 3 and 4 months; visit 7 at 6 months to evaluate effectiveness, and visit 8 at 12 months. Weight will be monitored throughout. Assessments at baseline, 6, and 12 months will include labs, vital signs, and scales for psychopathology, quality of life, and activity level. Each session covers key topics, from intervention goals to diet tips and physical activity. The approach is flexible, aiming for gradual habit integration, supported by a therapeutic relationship. Phone reminders will enhance adherence. Receives: Behavioral: Nursing Consultation in Weight Management and Metabolic syndrome |
| Control | No intervention | Ccontrol group will continue their usual follow-up within the EIP, attending consultations with their reference psychiatrist and receiving pharmacological or psychotherapeutic treatment as they did before the intervention. The control group will not receive any specific nursing consultations (beyond the administration of long-acting injectable antipsychotics where appropriate) or dietary or lifestyle advice during the follow-up. If patients in the control group require treatment or assistance for metabolic problems, they will be referred to primary care or endocrinology professionals, as was done previous to the intervention implementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight in kilograms
Measured: From enrollment to the end of treatment at 48 weeks
Secondary outcomes (5)
Metabolic Syndrome
According to the International Diabetes Federation (IDF)
Measured: From enrollment to the end of treatment at 48 weeks
Psychopathology
measured using PANSS scale
Measured: From enrollment to the end of treatment at 48 weeks
Depressive symptoms
measured by Hamilton Depression Rating Scale
Measured: From enrollment to the end of treatment at 48 weeks
Qualit of Life
EuroQoL 5D scale will be used
Measured: From enrollment to the end of treatment at 48 weeks
Reported phisical activity
International Physical Activity Questionnaire (IPAQ)
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start25 Oct 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Episode Psychosis (FEP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Basurto
- Sponsor type
- University, hospital or other
- Collaborators
- Euskal Herriko Unibertsitatea. Universidad del Pais Vasco., Instituto Vasco de Investigación Sanitaria (BIOEF)
- Responsible party
- Principal investigator, Lander Madaria Marijuan, Hospital de Basurto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650943
- Sponsor's protocol ID
- 48.23 CEIHU
- Acronym
- MetaKOP
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madaria L, Aymerich C, Catalan A, Gonzalez-Torres MA. Protocol of an Efficacy Study on Nursing Consultation in Weight Management and Metabolic Syndrome Based on the Carbohydrate-Insulin Theory in Individuals with First-Episode Psychosis. Nurs Rep. 2024 Dec 27;15(1):3. doi: 10.3390/nursrep15010003.
PubMed 39852625
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study on Nursing Consultation in Weight and Metabolic Syndrome Management Based on the Carbohydrate-insulin Theory in Individuals with First-episode Psychosis (MetaKOP)
- ClinicalTrials.gov ID
- NCT06650943
- Acronym / sponsor ID
- MetaKOP / 48.23 CEIHU
- Keywords
- FEP, psychosis, metabolic syndrome, nursing, mental health nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hospital de BasurtoUniversity, hospital or other
- Collaborators
- Euskal Herriko Unibertsitatea. Universidad del Pais Vasco., Instituto Vasco de Investigación Sanitaria (BIOEF)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate if a nursing intervention based on the carbohydrate-insulin model can effectively reduce weight and manage the risk of metabolic syndrome (MetS) in individuals with first-episode psychosis. The main questions it aims to answer are:
Will the intervention lead to a clinically significant weight loss (≥5%)? Can the intervention improve metabolic parameters, psychopathological state, physical activity level, and quality of life? Researchers will compare participants receiving the specialized nursing consultations to those receiving routine care to see if the former group experiences greater improvements in weight loss and metabolic risk reduction.
Participants will:
Attend a series of 8 nursing consultations focused on dietary habits based on the carbohydrate-insulin model and physical activity.
Complete assessments at the start, 6 months, and 12 months, including weight, metabolic parameters, and psychological evaluations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nursing Consultation in Weight Management and Metabolic syndromeThe intervention consists of 8 nursing consultations with a mental health nurse trained in healthy habits for individuals with psychosis. During the first 2 months, 4 consultations will focus on dietary habits based on the carbohydrate-insulin theory and physical activity, following a guide developed by experts, incorporating recommendations from the American Diabetes Association. Visits 5 and 6 occur at 3 and 4 months; visit 7 at 6 months to evaluate effectiveness, and visit 8 at 12 months. Weight will be monitored throughout. Assessments at baseline, 6, and 12 months will include labs, vital signs, and scales for psychopathology, quality of life, and activity level. Each session covers key topics, from intervention goals to diet tips and physical activity. The approach is flexible, aiming for gradual habit integration, supported by a therapeutic relationship. Phone reminders will enhance adherence. |
| Control | No intervention | –Ccontrol group will continue their usual follow-up within the EIP, attending consultations with their reference psychiatrist and receiving pharmacological or psychotherapeutic treatment as they did before the intervention. The control group will not receive any specific nursing consultations (beyond the administration of long-acting injectable antipsychotics where appropriate) or dietary or lifestyle advice during the follow-up. If patients in the control group require treatment or assistance for metabolic problems, they will be referred to primary care or endocrinology professionals, as was done previous to the intervention implementation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the Early Intervention Program (EIP).
- First-episode psychosis (FEP) within the last 5 years.
- Diagnosis of psychosis from the F2 spectrum or an affective disorder with psychotic symptoms according to ICD-10.
Key exclusion criteria (5 listed)
- Cognitive inability to learn or comorbid intellectual disability that interferes with study procedures.
- Comorbid diagnosis of neurological pathology.
- Language or comprehension impairments preventing accurate data collection.
- Use of hypoglycemic medication before or during the study.
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Consultation in Weight Management and Metabolic syndromeBased on the Carbohydrate-insulin Theory | Behavioural | Intervention |
Primary outcome
Weight
Time frame: From enrollment to the end of treatment at 48 weeks
Weight in kilograms
5 secondary outcomes
Metabolic Syndrome
Time frame: From enrollment to the end of treatment at 48 weeks
Psychopathology
Time frame: From enrollment to the end of treatment at 48 weeks
Depressive symptoms
Time frame: From enrollment to the end of treatment at 48 weeks
Qualit of Life
Time frame: From enrollment to the end of treatment at 48 weeks
Reported phisical activity
Time frame: From enrollment to the end of treatment at 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 39852625Madaria L, Aymerich C, Catalan A, Gonzalez-Torres MA. Protocol of an Efficacy Study on Nursing Consultation in Weight Management and Metabolic Syndrome Based on the Carbohydrate-Insulin Theory in Individuals with First-Episode Psychosis. Nurs Rep. 2024 Dec 27;15(1):3. doi: 10.3390/nursrep15010003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Consultation in Weight Management and Metabolic syndrome in people with First Episode Psychosis (FEP) and Metabolic Syndrome X, run by Hospital de Basurto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lander Madaria (646179740, lander.madariamarijuan@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: From enrollment to the end of treatment at 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.