Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03714217 |
| Other study ID # |
18-007 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2018 |
| Est. completion date |
June 20, 2019 |
Study information
| Verified date |
June 2019 |
| Source |
Santa Clara Valley Health & Hospital System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to provide tele-nutrition counseling after a spinal cord injury
(SCI). During the three months of participation, subjects will be given an iPad and the iPad
will be used to record meals using a photo journal application, YouAte. In addition, subjects
will receive dietary advice two times a month with a registered dietitian (RD). The dietitian
role in the study will be to educate healthy weight management and accommodate any cultural
and behavioral habits. The objective of this study is to show that the proposed
tele-nutrition program will be effective with weight management through 3-month
tele-nutrition counseling via iPad FaceTime. The hypotheses are 1) that weight and waist
circumference will not increase after 3 months of tele-nutrition program, 2) quality of life
will improve, and 3) quality of diet will improve.
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.
