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NCT Number: NCT04748835

The SEEA (SCI Energy Expenditure and Activity) Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Scott & White Institute for Rehabilitation - Dallas

Dallas, Texas, 75246, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. Changes in resting metabolic rate

    Time frame: 1 year

    As measured by resting metabolic rate using a MedGem device

  5. 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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Investigating Factors Related to Nutritional Intake and Weight Gain Among Those With SCI Over the First 12 Months Following Discharge From Inpatient Rehabilitation

Acronym: SEEA

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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