The SEEA (SCI Energy Expenditure and Activity) Study

• Conditions: Obesity; Metabolic Syndrome; Cardiovascular Diseases; Diet Habit; Spinal Cord Injuries

• Registration Number: NCT04748835
• Lead Sponsor: Baylor Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2020-10-22
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in nutritional intake	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.	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	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	1 year	As measured by resting metabolic rate using a MedGem device
Time spent performing physical activity	1 year	Time spent performing physical activity at each of the study timepoints will be measured using an Actigraph device

Trial Locations

Locations (1)

Baylor Scott & White Institute for Rehabilitation - Dallas; 🇺🇸 Dallas, Texas, United States