140 Participants Needed

Diet and Exercise for Schizophrenia

KT
Overseen ByKristina T Legget, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Must be taking: Olanzapine, Risperidone, Clozapine, Haloperidol
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.26789

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.1261011

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.

Research Team

JT

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.
See 1 more

Exclusion Criteria

MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
Pregnancy
Substance abuse
See 1 more

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
  • Exercise
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise interventionExperimental Treatment1 Intervention
10 weeks of a moderate exercise intervention
Group II: Diet interventionActive Control1 Intervention
10 weeks of a diet intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

A systematic review of two high-quality studies involving 48 patients with schizophrenia found conflicting evidence regarding the effects of physical exercise on hippocampal volume, although some increases were linked to better aerobic fitness and short-term memory.
The current evidence is insufficient to conclude that physical exercise positively influences brain health in individuals with schizophrenia, highlighting the need for further research into the neurobiological mechanisms and functional outcomes of exercise in this population.
Neurobiological effects of physical exercise in schizophrenia: a systematic review.Vancampfort, D., Probst, M., De Hert, M., et al.[2018]
An eight-month exercise program involving Greek traditional dancing significantly improved functional capacity in patients with schizophrenia, as evidenced by increased walking distance, better balance, and greater lower limb strength compared to a sedentary control group.
Participants in the dancing group also reported enhanced quality of life and improved mental health outcomes, indicating that engaging in physical activity can have positive effects on both physical and psychological well-being for individuals with schizophrenia.
Effects of exercise training with traditional dancing on functional capacity and quality of life in patients with schizophrenia: a randomized controlled study.Kaltsatou, A., Kouidi, E., Fountoulakis, K., et al.[2022]
Only 20.1% of patients with stable schizophrenia were physically active, compared to 35.9% of healthy individuals, indicating a significant gap in physical activity levels.
Only 29.5% of patients received physical activity counseling, suggesting a need for improved counseling strategies to encourage physical activity among this population.
[Levels and evaluations of physical activity using 5-A counseling model in patients with stable schizophrenia].Wang, J., Wei, Q., Li, G., et al.[2019]

References

Neurobiological effects of physical exercise in schizophrenia: a systematic review. [2018]
Effects of exercise training with traditional dancing on functional capacity and quality of life in patients with schizophrenia: a randomized controlled study. [2022]
[Levels and evaluations of physical activity using 5-A counseling model in patients with stable schizophrenia]. [2019]
Physical activity as a therapeutic method for non-pharmacological treatment of schizophrenia: A systematic literature review. [2023]
Multi-modal weight control intervention for people with persistent mental disorders. [2008]
Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review. [2019]
The effect of mind-body and aerobic exercise on negative symptoms in schizophrenia: A meta-analysis. [2020]
Resistance training in patients with schizophrenia: Concept and proof of principle trial. [2021]
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]
Effects of physical activity and nutrient supplementation on symptoms and well-being of schizophrenia patients: An umbrella review. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Making evidence-based lifestyle modification programs available in community mental health centers: why so slow? [2018]
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