The SEEA (SCI Energy Expenditure and Activity) Study

NCT04748835 | Completed

• 1 other identifier: 016-277
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Obesity; Metabolic Syndrome; Cardiovascular Diseases; Diet Habit

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  1 year

• Changes in resting metabolic rate

  As measured by resting metabolic rate using a MedGem device

  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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to complete repeat assessments
• Cognitive impairment or brain injury that limits ability to provide data

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Institute for Rehabilitation - Dallas

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Obesity; Metabolic Syndrome; Cardiovascular Diseases; Feeding Behavior

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior, Animal; Behavior

Study Officials

• Katherine Froehlich-Grobe, PhD

  Baylor Scott & White Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: February 10, 2021
• Study Start: September 20, 2018
• Primary Completion: April 22, 2021
• Study Completion: April 15, 2022
• Last Updated: March 5, 2026

Record last verified: 2025-10

Locations

US (1)