- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03714217
Telenutrition in Spinal Cord Injury
Weight Management in Spinal Cord Injury - Intervention and Monitoring Via Tele-Nutrition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants with spinal cord injury (traumatic or non-traumatic) will be recruited over a 9-month period from Santa Clara Valley Medical Center's (SCVMC) inpatient rehabilitation program before discharge as well as through the outpatient SCI clinic. Demographic data, weight /height, waist circumference as well as Life Satisfaction Index-A will be obtained at enrollment and 3-months post-enrollment. For subjects unable to return to the SCVMC clinic, questionnaires will be administered over the phone and they will be asked to measure their waist circumference by themselves and with assistance from a caregiver if needed. Each participant will be provided with an iPad and 4 month cellular data plan at the time of enrollment. iPad accessories like mouthstick will be provided if needed. Prior to initiating the tele-nutrition service, each participant will be instructed on how to use the iPad and FaceTime. Registered Dietitian Nutritionist (RDN) will provide an assessment of current knowledge and nutrition evaluation at enrollment in order to individualize intervention on a per-participant basis. Counseling twice a month over a 3 month time-period via tele-nutrition using iPad FaceTime will be provided for each participant. Tele-nutrition consults, via iPad with a food photo journal application (YouAte), would emphasize the importance of tracking food intake with the primary focus on healthy weight management. Nutrition education will be tailored according to and around each individual's cultural and behavioral practice with regards to food. Participants will be counseled with the goal to make incremental changes in current diet to better optimize energy, protein, fat, and fiber intake.
YouAte, a food journaling application, will be installed on each iPad and will have a three-month membership. This app is a mindful and simple way for participants to document their food intake for the review of the RDN over the course of this project. Once a picture is taken of a meal (with assistance from a caregiver if needed), participants can choose whether they feel the meal is on-path or off-path, based on their goals. Participants can further include information about the meal in a note section if they choose to. Additional, one-tap choices of the app can further tailor each meal's mindful approach to why it was eaten, how the meal made them feel, where they ate, how it was made, and how it made them feel. RDN will be able to review all meals and snacks in order to further discuss choices and provide valuable feedback with each participant to improve intake. At the end of the 3-month participation in the tele-nutrition program, each participant will be asked to complete a satisfaction survey in addition. This app will be set up using subject identifier such as a set of numbers and/or alias. So, no Protected Health Information such as name or date of birth will be entered or used to identify the diet journaling.
Data collected throughout the study will be used to provide preliminary evidence for the feasibility of the tele-nutrition program. Baseline measures will be used to characterize the cohort and measure changes across the intervention. Quantitative changes in weight and waist circumference, as well as satisfaction survey at the end of the assessment period will be used to measure feasibility. A combination of non-parametric statistics, most likely Wilcoxon Sign Ranked Tests, and clinical assessment will be used to measure whether the changes were significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Jose, California, United States, 95128
- Santa Clara Valley Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Older than 18 years
- Traumatic or non-traumatic SCI of any level
- Is or will be living at home
- Willing to participate in a tele-nutrition program.
Exclusion Criteria:
- Medically unstable
- Unable to speak English, as the dietitian who will be providing tele-nutrition speaks only English and tele-nutrition cannot be provided with a translator
- Living in a nursing home or hospitalized at a medical facility
- Has strict dietary guidelines (e.g. diabetic, heart failure, renal, ketogenic, etc)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Telenutrition counseling
|
A registered dietitian nutritionist will contact each participant twice a month for 3 months to provide nutrition counseling via iPad FaceTime.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: Baseline, 3 months
|
Weight in kg
|
Baseline, 3 months
|
Change in height
Time Frame: Baseline, 3 months
|
Height in cm
|
Baseline, 3 months
|
Change in waist circumference
Time Frame: Baseline, 3 months
|
Waist circumference in cm
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Life Satisfaction Index-A
Time Frame: Baseline, 3 months
|
The Life Satisfaction Index A is a 20-item tool assessing quality of life.
It has a total scoring range of 0 to 20, and a higher score signifies greater quality of life.
|
Baseline, 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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