Back to resultsVirtual Group Fitness and Nutrition Intervention for Individuals With Psychosis
Primary Purpose
Schizophrenia Spectrum Disorder (SSD)
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Fitness
Nutrition education
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia Spectrum Disorder (SSD) focused on measuring Lifestyle changes, Fitness instruction, Nutrition education, Virtual interventions
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:
- Acute myocardial infarction
- Ongoing unstable angina
- Uncontrolled cardiac arrhythmia with hemodynamic compromise
- Endocarditis
- Symptomatic severe aortic stenosis
- Decompensated heart failure
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
- Acute myocarditis or pericarditis
- Acute aortic dissection
- Inability to ambulate independently
Sites / Locations
- Massachusetts General Hospital
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A- Intervention/Non-Intervention
Group B- Non-Intervention/Intervention
Arm Description
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.
Participants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks.
Outcomes
Primary Outcome Measures
Feasibility of lifestyle intervention
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 educational nutritional sessions
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.
Tolerability of group fitness classes
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.
Secondary Outcome Measures
Change in physical activity level
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 weight
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 resting heart rate
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 Hemoglobin A1c level (HbA1c)
Study staff will abstract the HbA1c levels from the patient's Boston Medical Center (BMC) electronic record.
Change in psychological well being
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 self esteem
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.
Change in psychotic episodes
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
Motivation to exercise
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 nutritional knowledge
Change in nutrition knowledge will be measured through comparison of baseline and post intervention multiple choice test written by a registered dietician.
Full Information
NCT ID
NCT04783246
First Posted
February 28, 2021
Last Updated
August 28, 2023
Sponsor
Boston Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04783246
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Spectrum Disorder (SSD)
Keywords
Lifestyle changes, Fitness instruction, Nutrition education, Virtual interventions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A- Intervention/Non-Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B- Non-Intervention/Intervention
Arm Type
Active Comparator
Arm Description
Participants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group Fitness
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of lifestyle intervention
Description
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.
Time Frame
22 weeks
Title
Tolerability of educational nutritional sessions
Description
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.
Time Frame
22 weeks
Title
Tolerability of group fitness classes
Description
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.
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Change in physical activity level
Description
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.
Time Frame
baseline, 22 weeks
Title
Change in weight
Description
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.
Time Frame
baseline, 22 weeks
Title
Change in resting heart rate
Description
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.
Time Frame
baseline, 22 weeks
Title
Change in Hemoglobin A1c level (HbA1c)
Description
Study staff will abstract the HbA1c levels from the patient's Boston Medical Center (BMC) electronic record.
Time Frame
baseline, 22 weeks
Title
Change in psychological well being
Description
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.
Time Frame
baseline, 22 weeks
Title
Change in self esteem
Description
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.
Time Frame
baseline, 22 weeks
Title
Change in psychotic episodes
Description
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
Time Frame
baseline, 22 weeks
Title
Motivation to exercise
Description
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.
Time Frame
22 weeks
Title
Change in nutritional knowledge
Description
Change in nutrition knowledge will be measured through comparison of baseline and post intervention multiple choice test written by a registered dietician.
Time Frame
baseline, 22 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Acute myocardial infarction
Ongoing unstable angina
Uncontrolled cardiac arrhythmia with hemodynamic compromise
Endocarditis
Symptomatic severe aortic stenosis
Decompensated heart failure
Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
Acute myocarditis or pericarditis
Acute aortic dissection
Inability to ambulate independently
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Brown, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis
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