The SEEA (SCI Energy Expenditure and Activity) Study

Sponsor
Baylor Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04748835
Collaborator
(none)
42
1
38.4
1.1

Study Details

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 Intervention/Treatment Phase

    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 :
    Sep 20, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    3. 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.

    4. Changes in resting metabolic rate [1 year]

      As measured by resting metabolic rate using a MedGem device

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katherine Froehlich-Grobe, Director of Rehabilitation Research, Baylor Research Institute
    ClinicalTrials.gov Identifier:
    NCT04748835
    Other Study ID Numbers:
    • 016-277
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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:

    Study Results

    No Results Posted as of Feb 10, 2021