Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis

Not Applicable

Completed

• Conditions: Schizophrenia Spectrum Disorder (SSD)
• Interventions: Behavioral: Group Fitness; Other: Nutrition education

• Registration Number: NCT04783246
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Study Start: 2021-10-26
• Primary Completion: 2023-07-24
• Study Completion: 2023-07-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A- Intervention/Non-Intervention	Group Fitness	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.
Group B- Non-Intervention/Intervention	Group Fitness	Participants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks.
Group B- Non-Intervention/Intervention	Nutrition education	Participants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks.
Group A- Intervention/Non-Intervention	Nutrition education	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of lifestyle intervention	22 weeks	Feasibility of the lifestyle intervention will be assessed by the satisfaction level of participants which will be obtained from questions on an investigator developed questionnaire. Higher satisfaction levels will suggest greater feasibility.
Tolerability of group fitness classes	22 weeks	Individual attendance levels will be measured at weekly intervals during group fitness classes. Attendance will be calculated as the total number of attended groups divided by the total number of eligible groups to account for the late enrollment of individuals.
Tolerability of educational nutritional sessions	22 weeks	Individual attendance levels will be measured at weekly intervals during educational nutrition didactic sessions. Attendance will be calculated as the total number of attended groups divided by the total number of eligible groups to account for the late enrollment of individuals.

Secondary Outcome Measures

Name	Time	Method
Change in weight	baseline, 22 weeks	Participants will be asked to weigh themselves and document their weight. Either before or after each session the participant will share their weight with a research assistant on a phone call without other participants present.
Change in physical activity level	baseline, 22 weeks	Change in physical activity level will be measured through step counts which will be collected throughout the active intervention period via pedometers provided to study participants at the beginning of the trial period. Step counts will be logged weekly at group fitness classes.
Change in resting heart rate	baseline, 22 weeks	Participants will be taught how to obtain a resting heart rate and asked to document their resting heart rate. Either before or after each session the participant will share their resting heart rate with a research assistant on a phone call without other participants present.
Change in self esteem	baseline, 22 weeks	The change in scores from baseline to 22 weeks from the 12-item Short Form Health Survey (12-SFHS), State Self-Esteem Scale (SSES) will be used to assess self esteem change. The SSES scale has been validated in multiple populations as an assessment of an individual's sense of worthiness in three domains: (1) appearance, (2) performance, and (3) social Each item is scored on a 5-point scale (1 = not at all, 2 = a little bit, 3 = somewhat, 4 = very much, and 5 = extremely). Scores range form 20 to 100 and higher scores are associated with higher self esteem.
Motivation to exercise	22 weeks	Change in motivation to exercise will be measured through administration of Behavioral Regulation Exercise Questionnaire-3 (BREQ-3). Higher scores are associated with greater motivation to exercise.
Change in psychological well being	baseline, 22 weeks	Change in psychological well-being will be assessed through the administration of the Personal Health Questionnaire-9 (PHQ-9).The PHQ-9 has been previously validated in the general population to assess for major depressive disorder and subclinical depressive symptoms. Scores can range from 1-27 and the higher the score the greater the depressive symptoms.
Change in psychotic episodes	baseline, 22 weeks	Change in psychotic symptoms will be assessed through implementation of the Brief Psychiatric Rating Scale (BPRS). The BPRS is a validated instrument which measures several constructs important to the assessment of the severity of symptoms of psychosis such as degree of hallucinations, unusual thought content, self-neglect, and conceptual disorganization. Higher scores are associated with more psychotic episodes
Change in nutritional knowledge	baseline, 22 weeks	Change in nutrition knowledge will be measured through comparison of baseline and post intervention multiple choice test written by a registered dietician.
Change in Hemoglobin A1c level (HbA1c)	baseline, 22 weeks	Study staff will abstract the HbA1c levels from the patient's Boston Medical Center (BMC) electronic record.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States