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Completed

NCT Number: NCT04783246

Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis

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.

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Key information

Conditions

Schizophrenia Spectrum Disorder (SSD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Fitness

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in physical activity level

    Time frame: 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.

  2. Change in weight

    Time frame: 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.

  3. Change in resting heart rate

    Time frame: 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.

  4. Change in Hemoglobin A1c level (HbA1c)

    Time frame: baseline, 22 weeks

    Study staff will abstract the HbA1c levels from the patient's Boston Medical Center (BMC) electronic record.

  5. Change in psychological well being

    Time frame: 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.

  6. Change in self esteem

    Time frame: 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.

  7. Change in psychotic episodes

    Time frame: 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

  8. Motivation to exercise

    Time frame: 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.

  9. Change in nutritional knowledge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Feasibility and Effectiveness of a Virtual Group Fitness and Nutrition Intervention in Individuals With Psychosis: A Pilot Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2021
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.