Spinal Cord InjuriesSEEANCT04748835
The SEEA (SCI Energy Expenditure and Activity) Study
An observational study of Spinal Cord Injuries and Obesity, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Obesity, Metabolic Syndrome
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 15 Apr 2022
- Phase
- Observational
- 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
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to complete repeat assessments
- Cognitive impairment or brain injury that limits ability to provide data
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Institute for Rehabilitation - Dallas
Dallas, Texas, 75246
About this 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
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.
- Medical subject headings
- Spinal Cord Injuries, Obesity, Metabolic Syndrome, Cardiovascular Diseases, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutritional intake
Measure self-report and hospital reported average daily caloric intake, macronutrients (protein, fats, carbohydrates), and micronutrient (sodium) over 3 days at each study time point: baseline, 6 months, and 1 year
Measured: 1 year
Changes in environmental access to kitchen appliances and self-reported limitations and assistance needed for selecting, preparing, and eating meals.
Using the Assessment of life habits survey (abbreviated as LIFE-H) to determine the proportion of individuals with SCI who require assistance using kitchen appliances and preparing meals. Additional qualitative analyses will include examining the digital photos for intra-individual variation across time to determine whether there are changes to improve access to kitchen spaces and appliances.
Measured: 1 year
Correlation between psychosocial factors (mood, stress, coping, and sleep) and caloric intake
Mood will be measured using the Positive and Negative Affect States Scale (PANAS); stress will be measured using the Perceived Stress Scale (PSS-4); coping will be measuring using the Daily Coping Inventory (DCI); sleep will be measured with the Pittsburgh Sleep Quality Index (PSQI). Caloric intake is measured through participant self-report through the HealthWatch 360 app, the Automated Self-Administered Recall System (ASA-24) or through hospital records.
Measured: 1 year
Changes in resting metabolic rate
As measured by resting metabolic rate using a MedGem device
Measured: 1 year
Time spent performing physical activity
Time spent performing physical activity at each of the study timepoints will be measured using an Actigraph device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start20 Sep 2018
- Primary completion22 Apr 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Froehlich-Grobe, PhD, Principal investigator, Baylor Scott & White Institute for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748835
- Sponsor's protocol ID
- 016-277
- Acronym
- SEEA
- Status last verified
- Oct 2025
- First submitted
- 22 Oct 2020
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04748835
- Acronym / sponsor ID
- SEEA / 016-277
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 10 Feb 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling or unable to complete repeat assessments
- Cognitive impairment or brain injury that limits ability to provide data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in nutritional intake
Time frame: 1 year
Measure self-report and hospital reported average daily caloric intake, macronutrients (protein, fats, carbohydrates), and micronutrient (sodium) over 3 days at each study time point: baseline, 6 months, and 1 year
Changes in environmental access to kitchen appliances and self-reported limitations and assistance needed for selecting, preparing, and eating meals.
Time frame: 1 year
Using the Assessment of life habits survey (abbreviated as LIFE-H) to determine the proportion of individuals with SCI who require assistance using kitchen appliances and preparing meals. Additional qualitative analyses will include examining the digital photos for intra-individual variation across time to determine whether there are changes to improve access to kitchen spaces and appliances.
Correlation between psychosocial factors (mood, stress, coping, and sleep) and caloric intake
Time frame: 1 year
Mood will be measured using the Positive and Negative Affect States Scale (PANAS); stress will be measured using the Perceived Stress Scale (PSS-4); coping will be measuring using the Daily Coping Inventory (DCI); sleep will be measured with the Pittsburgh Sleep Quality Index (PSQI). Caloric intake is measured through participant self-report through the HealthWatch 360 app, the Automated Self-Administered Recall System (ASA-24) or through hospital records.
Changes in resting metabolic rate
Time frame: 1 year
As measured by resting metabolic rate using a MedGem device
Time spent performing physical activity
Time frame: 1 year
Time spent performing physical activity at each of the study timepoints will be measured using an Actigraph device
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 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
Recruiting
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Spinal Cord Injuries
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries
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.
Katherine Froehlich-Grobe, PhD principal investigator
Baylor Scott & White Institute for Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Obesity, run by Baylor Research Institute at 1 site 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 2 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 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in nutritional intake (time frame: 1 year). The study lists 5 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 5 Mar 2026.