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ArticleFrontiers in nutrition2026

Clinical dietitian-led nutrition counseling and exercise to reduce cardiovascular risk in adults living with a BMI above 27 and severe mental illness: the NORMI-Heart trial protocol.

Madeleine Elisabeth Angelsen, Hemen Najar, Mette Svendsen, Magne Thoresen, Dawn Elizabeth Peleikis, Kjetil Retterstøl

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT07085923 (Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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2 · The registry

The trial behind it

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NCT07085923 narecruitingnot on this map

Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness

TypeinterventionalSponsorMadeleine Elisabeth AngelsenRan2025 to 2028Enrolled70ConditionsCardio Vascular Disease, Metabolic Syndrome (MetS), Severe Mental Disorder, Schizophrenia and Schizophrenia Spectrum PsychosisArmsLifestyle Intervention
3 · Its place in the literature

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Madeleine Elisabeth AngelsenDepartment of Nutrition, Faculty of Medicine, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
Hemen NajarDepartment of Psychotic Disorders, Sahlgrenska University Hospital, Västra Götaland Region, Gothenburg, Sweden.
Mette SvendsenDepartment of Psychotic Disorders, Sahlgrenska University Hospital, Västra Götaland Region, Gothenburg, Sweden.
Magne ThoresenSection for Preventive Cardiology, Department for Endocrinology, Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.
Dawn Elizabeth PeleikisDepartment of Biostatistics, Faculty of Medicine, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.
Kjetil RetterstølDepartment of Nutrition, Faculty of Medicine, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Severe mental illness (SMI) is associated with high cardiovascular disease (CVD) risk. Important contributors are poor diet quality, physical inactivity, and metabolic side effects of antipsychotic medication entailing significant weight gain. Evidence implies that dietary counseling delivered by clinical dietitians leads to greater improvements in diet quality, weight management, and cardiometabolic health than counseling delivered by non-specialist health personnel, especially when combined with increased physical activity. However, randomized controlled trials (RCTs) testing clinical dietitian-led nutrition counseling integrated with structured exercise across diverse treatment modalities in psychiatric care remain scarce. Objective: The Norwegian Mental Illness Heart Health (NORMI-Heart) study will evaluate the efficacy and applicability of a 6-month lifestyle program, combining individualized, clinical dietitian-led nutrition counseling focused on weight reduction and improved dietary quality, and moderate-to-vigorous exercise training, on CVD risk in adults with SMI in Oslo, Norway. Methods: This parallel-group RCT will recruit 70 overweight adults with SMI. Participants will be randomized to a 6-month diet and lifestyle intervention, or control. The intervention is individualized and includes monthly one-to-one sessions with a clinical dietitian focusing on heart-healthy eating and weight reduction, monthly supervised group exercise, and support to follow an individual exercise program. Control participants will receive treatment as usual (TAU). The NORMI-Heart Trial aims to evaluate the effect of the intervention on estimated CVD risk. Expected outcomes: This trial aims to provide evidence on the effectiveness, feasibility, and real-world applicability of clinical dietitian-led nutrition counseling combined with structured exercise for reducing CVD risk in individuals with SMI. Findings may strengthen the scientific and policy rationale for integrating clinical dietitians as a standard part of multidisciplinary mental health care. Results will also inform scalable, integrated lifestyle care models in mental health services. Trial registration: ClinicalTrials.gov Identifier: [NCT07085923].

Indexed as

cardiovascular diseaseclinical dietitianheart healthlifestyle interventionmetabolic risk factorpsychiatrysevere mental illnessweight reduction

Identifiers

PMID41769638
PMCPMC12935603

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