Schizophrenia Spectrum Disorder (SSD)NCT04783246
Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis
A study testing Group Fitness and Nutrition education in people with Schizophrenia Spectrum Disorder (SSD), run by Boston Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Spectrum Disorder (SSD)
- What is being tested?
- Group Fitness and Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Oct 2021to 24 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Decompensated heart failure
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
- Acute myocarditis or pericarditis
- Acute aortic dissection
- Inability to ambulate independently
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Feasibility and Effectiveness of a Virtual Group Fitness and Nutrition Intervention in Individuals With Psychosis: A Pilot Study
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.
- Conditions
- Schizophrenia Spectrum Disorder (SSD)
- Being tested
- Group Fitness, Nutrition education
- Keywords
- Lifestyle changes, Fitness instruction, Nutrition education, Virtual interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group FitnessBehavioural
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.
Nutrition educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A- Intervention/Non-Intervention | Experimental | 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. Receives: Behavioral: Group Fitness; Other: Nutrition education |
| Group B- Non-Intervention/Intervention | Active comparator | Participants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks. Receives: Behavioral: Group Fitness; Other: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 weeks
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.
Measured: 22 weeks
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.
Measured: 22 weeks
Secondary outcomes (9)
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.
Measured: baseline, 22 weeks
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.
Measured: baseline, 22 weeks
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.
Measured: baseline, 22 weeks
Change in Hemoglobin A1c level (HbA1c)
Study staff will abstract the HbA1c levels from the patient's Boston Medical Center (BMC) electronic record.
Measured: baseline, 22 weeks
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.
Measured: baseline, 22 weeks
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.
Measured: baseline, 22 weeks
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
Measured: baseline, 22 weeks
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.
Measured: 22 weeks
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.
Measured: baseline, 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start26 Oct 2021
- Primary completion24 Jul 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum Disorder (SSD)Studies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah Brown, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783246
- Sponsor's protocol ID
- H-40042
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Virtual Group Fitness and Nutrition Intervention in Individuals With Psychosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT04783246
- Acronym / sponsor ID
- H-40042
- Conditions
- Schizophrenia Spectrum Disorder (SSD)
- Keywords
- Lifestyle changes, Fitness instruction, Nutrition education, Virtual interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A- Intervention/Non-Intervention | Experimental | Behavioral: Group Fitness, Other: Nutrition educationParticipants 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 | Active comparator | Behavioral: Group Fitness, Other: Nutrition educationParticipants in this arm will initially be randomized to the non-intervention period for 11 weeks followed by the intervention period for 11 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- Inability to ambulate independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group FitnessThe 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. | Behavioural | Group A- Intervention/Non-Intervention, Group B- Non-Intervention/Intervention |
| Nutrition educationThe 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. | Other | Group A- Intervention/Non-Intervention, Group B- Non-Intervention/Intervention |
Primary outcome
Feasibility of lifestyle intervention
Time frame: 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 educational nutritional sessions
Time frame: 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.
Tolerability of group fitness classes
Time frame: 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.
9 secondary outcomes
Change in physical activity level
Time frame: baseline, 22 weeks
Change in weight
Time frame: baseline, 22 weeks
Change in resting heart rate
Time frame: baseline, 22 weeks
Change in Hemoglobin A1c level (HbA1c)
Time frame: baseline, 22 weeks
Change in psychological well being
Time frame: baseline, 22 weeks
Change in self esteem
Time frame: baseline, 22 weeks
Change in psychotic episodes
Time frame: baseline, 22 weeks
Motivation to exercise
Time frame: 22 weeks
Change in nutritional knowledge
Time frame: baseline, 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia Spectrum Disorder (SSD)
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
Not yet recruiting
Psychotherapy for Self-Disorders in Schizophrenia Spectrum Disorder
Schizophrenia Spectrum Disorders (SSD)
Recruiting
Oxytocin-Augmented Group Psychotherapy for Patients With Schizophrenia - an Oxytocin-dose Comparison
Schizophrenia Spectrum Disorders (SSD)
Active, not recruitingPhase 2
Enhancing Social Skills in Schizophrenia Spectrum Disorders - Oxytocin as add-on to Psychosocial Treatment
Schizophrenia Spectrum Disorders (SSD)
Active, not recruiting
Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder
Bipolar Disorder (BD), Schizophrenia Spectrum Disorders (SSD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Brown, MD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Fitness and Nutrition education in people with Schizophrenia Spectrum Disorder (SSD), run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of lifestyle intervention (time frame: 22 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.