Clinical trial NCT04748835: The SEEA (SCI Energy Expenditure and Activity) Study
Official title: Investigating Factors Related to Nutritional Intake and Weight Gain Among Those With SCI Over the First 12 Months Following Discharge From Inpatient Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Obesity
Metabolic Syndrome
Cardiovascular Diseases
Diet Habit
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are people who have incurred a spinal cord injury within the previous 18 months prior to study enrollment who have been admitted to inpatient rehabilitation at Baylor Scott \& White Institute for Rehabilitation in Dallas, TX. Participants must have or be expected to regain enough arm/hand function to feed themselves independently and be willing and able to complete physical measurements and surveys.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in nutritional intake
timeFrame: 1 year
measure: Changes in environmental access to kitchen appliances and self-reported limitations and assistance needed for selecting, preparing, and eating meals.
timeFrame: 1 year
measure: Correlation between psychosocial factors (mood, stress, coping, and sleep) and caloric intake
timeFrame: 1 year
measure: Changes in resting metabolic rate
timeFrame: 1 year
measure: Time spent performing physical activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation - Dallas
state: Texas
Study officials:
affiliation: Baylor Scott & White Institute for Rehabilitation
name: Katherine Froehlich-Grobe, PhD
role: PRINCIPAL_INVESTIGATOR
References: