Telenutrition for Individuals With SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorSanta Clara Valley Health & Hospital System
About this trial
This study will provide nutrition counseling via FaceTime on an iPad to persons with traumatic spinal cord injury (SCI) who are overweight or obese and are at least one-year post-injury. Nutrition counseling may help participants to develop eating behaviors that match the participants' needs and help improve heart health. The purpose of this project is to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. This study will require 3 in person visits that are about 3 months apart. The total length of the study is about 6 months and includes 3 months of telenutrition counseling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals with traumatic SCI
At least 1-year post-injury
Age 20 years of age or older
BMI > 22 kg/m2 at enrollment
Disqualifiers
Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury)
Current self-reported pregnancy
Other medical condition requiring a strict specialized diet (e.g., renal failure, diabetes)
Participation in another diet program (e.g., Jenny Craig, Weight Watchers, clinic-based program) and/or participated in another diet program within the past 6 months
Trial design
Design model
Crossover
Treatments tested in this trial
Telenutrition
BehavioralNutrition education and individualized nutrition counseling will be done with a Registered Dietitian via video-conferencing with iPad FaceTime, which is aimed to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. The telenutrition counseling consists of 6 sessions that are scheduled approximately 2 weeks apart. The first session will last approximately 1 hour, while sessions 2-6 will last approximately 30mins. During these sessions, the Registered Dietitian will share nutrition education tailored towards people with SCI. You will be involved in developing personal nutrition goals and the dietitian will help you address barriers to meeting your goals and provide individualized feedback to improve and maintain your nutrition. Telenutrition appointments will maintain privacy and will not be recorded.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Immediate treatmentExperimental treatment 1 intervention
Group B: Delayed TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Healthy Eating Index (HEI) scores
HEI scores from participants' individual dietary intakes at different time-points of evaluations (baseline/pre-intervention, end of 3 months from baseline, end of 6 months from baseline) will be reported. Changes in HEI scores following intervention will be compared to pre-intervention baseline scores (within group comparison) as well as scores from the waitlisted group (between group comparison) and reported accordingly. In addition, longer-term changes in HEI scores (for individuals from the immediate intervention group) during the durability phase will also be reported.
Time frame
0, 3 and 6 monthsSecondary outcomes
1
Blood lipid profile
Lipid profile constituting of Triglycerides (TG), Total Cholesterol (TC); low-density lipoprotein (LDL) and High-density lipoprotein (HDL)- values (all expressed as mg/dL) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes in values will also be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).
Time frame
0, 3 and 6 months2
HbA1C
Blood values of HbA1C (expressed as percentage) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in percent values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).
Time frame
0, 3 and 6 months3
Vitamin D
Blood values of Vitamin D (expressed as ng/mL) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).
Time frame
0, 3 and 6 months4
high-sensitivity C-reactive protein [hs-CRP]
Blood values of hs-CRP (expressed as mg/L) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group)
Time frame
0, 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Santa Clara Valley Health & Hospital System
Lead sponsor
San Jose State University
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov