The SEEA (SCI Energy Expenditure and Activity) Study

NCT ID: NCT04748835

Last Updated: 2021-02-10

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

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-20

Study Completion Date

2021-12-31

Brief Summary

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People with SCI are at higher risk of obesity and chronic diseases, such as hypertension, high cholesterol, diabetes and cardiovascular disease, than the general population. Researchers currently lack data on factors that influence weight gain among people with SCI. During this one-year observational study, study staff will enroll 60 individuals with SCI while they are inpatients at Baylor Scott \& White Institute for Rehabilitation (BSWIR). Data will be collected at 3 time periods (before discharge and 6 and 12 months after discharge) in order to better understand factors that affect weight gain over the first 12 months following discharge from inpatient rehabilitation, such as nutritional intake, environmental access, psychosocial factors, energy requirements and risk factors for metabolic syndrome. These data will be used to inform future interventions for people with SCI.

Detailed Description

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Conditions

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Spinal Cord Injuries Obesity Metabolic Syndrome Cardiovascular Diseases Diet Habit

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults ≥18 years with complete or incomplete spinal cord injury (SCI)
* Currently have or are expected to regain enough arm function within 6 months to feed themselves independently.
* Injury occurred within previous 18 months

Exclusion Criteria

* Unwilling or unable to complete repeat assessments
* Cognitive impairment or brain injury that limits ability to provide data
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Katherine Froehlich-Grobe

Director of Rehabilitation Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine Froehlich-Grobe, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White Institute for Rehabilitation

Locations

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Baylor Scott & White Institute for Rehabilitation - Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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016-277

Identifier Type: -

Identifier Source: org_study_id

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