Clinical trial NCT04783246: Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis
Official title: Feasibility and Effectiveness of a Virtual Group Fitness and Nutrition Intervention in Individuals With Psychosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum Disorder (SSD)
Keywords: Lifestyle changes
Fitness instruction
Nutrition education
Virtual interventions
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of lifestyle intervention
timeFrame: 22 weeks
measure: Tolerability of educational nutritional sessions
timeFrame: 22 weeks
measure: Tolerability of group fitness classes
timeFrame: 22 weeks
Secondary outcomes:
measure: Change in physical activity level
timeFrame: baseline, 22 weeks
measure: Change in weight
timeFrame: baseline, 22 weeks
measure: Change in resting heart rate
timeFrame: baseline, 22 weeks
measure: Change in Hemoglobin A1c level (HbA1c)
timeFrame: baseline, 22 weeks
measure: Change in psychological well being
timeFrame: baseline, 22 weeks
measure: Change in self esteem
timeFrame: baseline, 22 weeks
measure: Change in psychotic episodes
timeFrame: baseline, 22 weeks
measure: Motivation to exercise
timeFrame: 22 weeks
measure: Change in nutritional knowledge
timeFrame: baseline, 22 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Hannah Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: