Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis

NCT ID: NCT04783246

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-26

Study Completion Date

2023-07-24

Brief Summary

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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

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Conditions

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Schizophrenia Spectrum Disorder (SSD)

Keywords

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Lifestyle changes Fitness instruction Nutrition education Virtual interventions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Group Fitness

Intervention Type BEHAVIORAL

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 education

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Group Fitness

Intervention Type BEHAVIORAL

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 education

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-40042

Identifier Type: -

Identifier Source: org_study_id