Diet and Exercise for Schizophrenia

Recruiting in Palo Alto (17 mi)

Overseen by Jason R. Tregellas, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Must be taking: Olanzapine, Risperidone, Clozapine, Haloperidol

Disqualifiers: Pregnancy, Substance abuse, Endocrine/metabolic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it includes participants who are either on specific medications (olanzapine, risperidone, clozapine, or haloperidol) or not on any neuroleptic medications, so it seems you can continue your current treatment if it fits these criteria.

What data supports the effectiveness of the treatment Diet, Exercise, Physical Activity, Workout, Fitness Training for schizophrenia?

Research shows that physical exercise can improve the quality of life and functional capacity in people with schizophrenia. Additionally, a study found that a combination of behavior intervention, nutritional information, and physical exercise helped reduce body weight and maintain this loss in people with schizophrenia. ^{1 2 3 4 5}

Is diet and exercise safe for people with schizophrenia?

Research shows that people with schizophrenia can safely participate in various forms of exercise, including aerobic and resistance training, with positive effects on their health and functioning. These activities have been studied and found to be safe, helping to improve physical fitness and reduce some symptoms without significant safety concerns. ^{2 6 7 8 9}

How does the 'Diet and Exercise for Schizophrenia' treatment differ from other treatments for this condition?

This treatment is unique because it focuses on lifestyle changes, specifically diet and exercise, to improve the quality of life and reduce metabolic risks in schizophrenia patients, rather than relying solely on medication. It addresses both physical health and mental well-being, which is not typically the primary focus of standard schizophrenia treatments. ^{1 2 6 10 11}

Research Team

Jason R. Tregellas, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults aged 21-70 with schizophrenia or schizoaffective disorder, who are either on olanzapine, risperidone, clozapine, haloperidol or not on neuroleptic medications. They should have had a stable weight in the past 6 months. Pregnant individuals, those with substance abuse issues or significant metabolic diseases, and anyone unable to undergo MRI due to claustrophobia or metal implants cannot participate.

Inclusion Criteria

I have been diagnosed with schizophrenia or schizoaffective disorder.

I am taking olanzapine, risperidone, clozapine, or haloperidol, or I am not on any neuroleptic medications.

I am between 21 and 70 years old.

Exclusion Criteria

MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Pregnancy

Substance abuse

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Intervention

Participants undergo a moderate exercise intervention to evaluate changes in brain responses and food preferences

10 weeks

Diet Intervention

Participants follow a diet intervention to evaluate changes in brain responses and food preferences

10 weeks

Follow-up

Participants are monitored for changes in neuronal response and fasting hormone levels after interventions

4 weeks

Treatment Details

Interventions

• Diet (Behavioral Intervention)
• Exercise (Behavioral Intervention)

Trial Overview The study examines how diet and exercise affect brain response to food images and preferences in people taking common schizophrenia drugs that may cause weight gain. Participants will be asked about their eating habits and symptoms and might do an exercise or diet program to see if it changes how their brain reacts to food.

Participant Groups

Group I: Exercise intervention Experimental Treatment 1 Intervention

10 weeks of a moderate exercise intervention

Group II: Diet intervention Active Control 1 Intervention

10 weeks of a diet intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

A study involving 59 hospitalized patients with schizophrenia showed that a behavioral intervention, including nutritional education and physical exercise, led to significant reductions in BMI and weight after 3 months, which were maintained for a year.

The results suggest that with proper support and information, individuals with persistent schizophrenia can effectively manage their weight and improve their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-modal weight control intervention for people with persistent mental disorders. Melamed, Y., Stein-Reisner, O., Gelkopf, M., et al.[2008]

Non-pharmacological interventions, including psychoeducation, diet, and physical activity, were effective in reducing metabolic syndrome risk factors in individuals with schizophrenia, as shown in a review of 11 studies from 1968 to 2017.

These interventions led to significant reductions in body weight, body mass index, waist circumference, and blood glucose levels, demonstrating that lifestyle changes are a safe and cost-effective approach to managing antipsychotic-induced weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review. Gurusamy, J., Gandhi, S., Damodharan, D., et al.[2019]

Physical exercise (PE) has a medium significant effect on reducing negative symptoms in schizophrenia patients, based on a meta-analysis of 22 studies involving 1249 participants.

Mind-body exercise (MBE) showed a stronger effect (medium significance) compared to aerobic exercise (AE), which had a smaller but still significant effect, indicating that different types of exercise may have varying levels of efficacy in managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mind-body and aerobic exercise on negative symptoms in schizophrenia: A meta-analysis. Vogel, JS., van der Gaag, M., Slofstra, C., et al.[2020]

A 12-week resistance training program was found to be safe for schizophrenia patients and led to significant improvements in their level of functioning, as measured by the Global Assessment of Functioning Scale (GAF).

Although the resistance training did not show significant effects on health-related difficulties assessed by the WHO-DAS, the positive outcomes suggest that tailored resistance training could be beneficial for managing symptoms and improving quality of life in schizophrenia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training in patients with schizophrenia: Concept and proof of principle trial. Maurus, I., Mantel, C., Keller-Varady, K., et al.[2021]

Aerobic exercise training significantly reduces negative symptoms of schizophrenia, as indicated by improvements in the Positive and Negative Syndrome Scale (PANSS) scores, while resistance training did not show significant effects on these symptoms.

Overall, participation in any form of exercise (aerobic, resistance, or combined) leads to improvements in health-related physical fitness indicators, including body mass index and oxygen consumption, highlighting the benefits of exercise for individuals living with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic, Resistance, and Combined Exercise Training on Psychiatric Symptom Severity and Related Health Measures in Adults Living With Schizophrenia: A Systematic Review and Meta-Analysis. Bredin, SSD., Kaufman, KL., Chow, MI., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Neurobiological effects of physical exercise in schizophrenia: a systematic review. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Effects of exercise training with traditional dancing on functional capacity and quality of life in patients with schizophrenia: a randomized controlled study. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Levels and evaluations of physical activity using 5-A counseling model in patients with stable schizophrenia]. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Physical activity as a therapeutic method for non-pharmacological treatment of schizophrenia: A systematic literature review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Multi-modal weight control intervention for people with persistent mental disorders. [2008]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

The effect of mind-body and aerobic exercise on negative symptoms in schizophrenia: A meta-analysis. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Resistance training in patients with schizophrenia: Concept and proof of principle trial. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Aerobic, Resistance, and Combined Exercise Training on Psychiatric Symptom Severity and Related Health Measures in Adults Living With Schizophrenia: A Systematic Review and Meta-Analysis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of physical activity and nutrient supplementation on symptoms and well-being of schizophrenia patients: An umbrella review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Making evidence-based lifestyle modification programs available in community mental health centers: why so slow? [2018]