The SEEA (SCI Energy Expenditure and Activity) Study

Obesity Clinical Trial

— SEEA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04748835
• Other study ID #: 016-277
• Status: Active, not recruiting
• Start date: September 20, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Baylor Scott & White Institute for Rehabilitation - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Changes in resting metabolic rate	As measured by resting metabolic rate using a MedGem device	1 year
Primary	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