Purpose

Individuals with schizophrenia spectrum disorder (SSD) often face unique barriers that limit the development of long-lasting lifestyle changes. In this study, The investigators will investigate the feasibility and impact of a novel lifestyle intervention in individuals with schizophrenia or schizoaffective disorder. The intervention will be composed of group fitness instruction and educational nutrition didactics that will be accessible to participants at-home through remote streaming. The fitness component will consist of weekly group fitness sessions delivered by a certified personal trainer over a virtual interface. The educational nutritional component of this intervention will involve interactive didactic sessions designed to improve knowledge of nutrition and positively change dietary behavior in this population.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Receiving outpatient psychiatric care for early-episode psychosis, schizophrenia, or schizoaffective disorder at Boston Medical Center or the Mass General Hospital - Proficient in English - Cleared by their primary care provider to perform 30 minutes of aerobic and strength exercise

Exclusion Criteria

  • Documented history of one of the absolute contraindications to exercise defined in the "Exercise Standards for Testing and Training" by the American Heart Association in our electronic medical record which includes the following: 1. Acute myocardial infarction 2. Ongoing unstable angina 3. Uncontrolled cardiac arrhythmia with hemodynamic compromise 4. Endocarditis 5. Symptomatic severe aortic stenosis 6. Decompensated heart failure 7. Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis 8. Acute myocarditis or pericarditis 9. Acute aortic dissection - Inability to ambulate independently

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
A two-period cross over design will be implemented to compare between groups in a self-paired manner to minimize the effects of confounding covariates. Participants will agree to either immediate randomization to the non-intervention period or the intervention period at the time of consent. Participants will be randomized utilizing conceal block randomization.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A- Intervention/Non-Intervention
Participants in this arm will initially be randomized to the intervention period and will receive the interventions for 11 weeks followed by no interventions for 11 weeks.
  • Behavioral: Group Fitness
    The group fitness intervention will involve streaming a group fitness class lead by a certified personal trainer. certified personal trainer and include variations of body-weight strength and aerobic exercise activities. Each work out session will be 30 minutes in duration and follow a structure of a warm-up period, alternating strength and aerobic exercises of varying intensity, and a cool-down period. The videos will be streamed to the group by a facilitator over Zoom video conferencing.
  • Other: Nutrition education
    The nutrition education intervention will involve 45-minute educational sessions involving didactic teaching, interactive goal setting, and a live cooking demonstration. Each session will be taught by a registered dietician who will also be responsible for designing the curriculum schedule.
Active Comparator
Group B- Non-Intervention/Intervention
Participants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks.
  • Behavioral: Group Fitness
    The group fitness intervention will involve streaming a group fitness class lead by a certified personal trainer. certified personal trainer and include variations of body-weight strength and aerobic exercise activities. Each work out session will be 30 minutes in duration and follow a structure of a warm-up period, alternating strength and aerobic exercises of varying intensity, and a cool-down period. The videos will be streamed to the group by a facilitator over Zoom video conferencing.
  • Other: Nutrition education
    The nutrition education intervention will involve 45-minute educational sessions involving didactic teaching, interactive goal setting, and a live cooking demonstration. Each session will be taught by a registered dietician who will also be responsible for designing the curriculum schedule.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Hannah Brown, MD
617-414-1917
Hannah.Brown2@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Hannah Brown, MD
617-414-1917
Hannah.Brown2@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.