The SEEA (SCI Energy Expenditure and Activity) Study (SEEA)

• ClinicalTrials.gov Identifier: NCT04748835
• Recruitment Status: Active, not recruiting
• First Posted: February 10, 2021
• Last Update Posted: February 10, 2021
• Sponsor: Baylor Research Institute
• Information provided by (Responsible Party): Katherine Froehlich-Grobe, Baylor Research Institute

Study Description

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.

Condition or disease
Spinal Cord Injuries; Obesity; Metabolic Syndrome; Cardiovascular Diseases; Diet Habit

Study Design

• Study Type: Observational
• Actual Enrollment: 42 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: September 20, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Locations

United States, Texas

Baylor Scott & White Institute for Rehabilitation - Dallas

Dallas, Texas, United States, 75246

Sponsors and Collaborators

Baylor Research Institute

Investigators

• Principal Investigator: Katherine Froehlich-Grobe, PhD; Baylor Scott & White Institute for Rehabilitation

More Information

• Responsible Party: Katherine Froehlich-Grobe, Director of Rehabilitation Research, Baylor Research Institute
• ClinicalTrials.gov Identifier: NCT04748835
• Other Study ID Numbers: 016-277
• First Posted: February 10, 2021
• Last Update Posted: February 10, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Spinal Cord Injuries; Cardiovascular Diseases; Metabolic Syndrome; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries