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Diet and exercise may add years to lives of those with severe mental illness

NCT ID NCT07085923

Disease control Sponsor: Madeleine Elisabeth Angelsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a six-month program of dietary counseling and group exercise can reduce heart disease risk in adults with severe mental illnesses like schizophrenia or bipolar disorder. Around 70 participants will either receive the lifestyle program plus usual care, or usual care alone. The goal is to see if the program improves heart health, body weight, and lifestyle habits, and whether it is acceptable to participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder) * Current use of antipsychotic medication (first- or second generation) or lithium * Body Mass Index \> or = 27 kg/m\^2 Exclusion Criteria: Psychiatric condition: * Inability to provide informed consent\* * Acute psychiatric crisis\* * Significant cognitive impairment\* \*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment Medication initiated during the intervention period: * GLP-1 receptor agonists * Antihypertensive medication * Antidiabetic medication * Lipid-lowering medication Alcohol consumption: -More than 14 units per week (men) or more than 7 units per week (women) Somatic conditions: * Type 1 diabetes * Established cardiovascular disease * Body Mass Index (BMI) \<27 kg/m² * Pregnancy * Inability to perform physical exercise Somatic risk findings at baseline: * HbA1c \>57 mmol/mol (7.4%) * LDL cholesterol \>5.0 mmol/L * Blood pressure \>180/100 mmHg * Active malignant disease

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome bipolar disorder bipolar I disorder cardiovascular disorder mental disorder metabolic syndrome X Motor Activity obesity disorder psychiatric disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disease type I Cardio vascular disease CVD risk factors Metabolic syndrome (METS) Overweight and/or obesity Schizophrenia and schizophrenia spectrum psychosis Severe mental disorder Severe mental illness

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department for nutrition science, Domus Medica, University of Oslo

    RECRUITING

    Oslo, 0372, Norway

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