search
Back to results

Telenutrition in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telenutrition Counseling
Sponsored by
Santa Clara Valley Health & Hospital System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Obesity, Telenutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Santa Clara Valley Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Telenutrition counseling

Outcomes

Primary Outcome Measures

Change in weight
Weight in kg
Change in height
Height in cm
Change in waist circumference
Waist circumference in cm

Secondary Outcome Measures

Change in Life Satisfaction Index-A
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.

Full Information

First Posted
October 17, 2018
Last Updated
September 20, 2021
Sponsor
Santa Clara Valley Health & Hospital System
search

1. Study Identification

Unique Protocol Identification Number
NCT03714217
Brief Title
Telenutrition in Spinal Cord Injury
Official Title
Weight Management in Spinal Cord Injury - Intervention and Monitoring Via Tele-Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Clara Valley Health & Hospital System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Obesity
Keywords
Spinal Cord Injury, Obesity, Telenutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Telenutrition counseling
Intervention Type
Behavioral
Intervention Name(s)
Telenutrition Counseling
Intervention Description
A registered dietitian nutritionist will contact each participant twice a month for 3 months to provide nutrition counseling via iPad FaceTime.
Primary Outcome Measure Information:
Title
Change in weight
Description
Weight in kg
Time Frame
Baseline, 3 months
Title
Change in height
Description
Height in cm
Time Frame
Baseline, 3 months
Title
Change in waist circumference
Description
Waist circumference in cm
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Life Satisfaction Index-A
Description
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.
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuko Shem, MD
Organizational Affiliation
Santa Clara Valley Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telenutrition in Spinal Cord Injury

We'll reach out to this number within 24 hrs