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Spinal Cord InjuryNCT03714217

Telenutrition in Spinal Cord Injury

A study testing Telenutrition Counseling in people with Spinal Cord Injury and Obesity, run by Santa Clara Valley Health & Hospital System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury, Obesity
What is being tested?
Telenutrition Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
3 Jul 2018to 20 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Santa Clara Valley Medical Center

    San Jose, California, 95128

Other trials in United States

About this study

Official title: Weight Management in Spinal Cord Injury - Intervention and Monitoring Via Tele-Nutrition

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.

Read the 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.

Being tested
Telenutrition Counseling
Keywords
Spinal Cord Injury, Obesity, Telenutrition
Medical subject headings
Spinal Cord Injuries, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telenutrition CounselingBehavioural

    A registered dietitian nutritionist will contact each participant twice a month for 3 months to provide nutrition counseling via iPad FaceTime.

Study groups in NCT03714217
Study groupRoleWhat they receive
InterventionExperimentalTelenutrition counseling
Receives: Behavioral: Telenutrition Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight

    Weight in kg

    Measured: Baseline, 3 months

  2. Change in height

    Height in cm

    Measured: Baseline, 3 months

  3. Change in waist circumference

    Waist circumference in cm

    Measured: Baseline, 3 months

Secondary outcomes (1)
  1. 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.

    Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2018
  2. Study start3 Jul 2018
  3. Primary completion20 Jun 2019
  4. Study completion20 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03714217
Sponsor's protocol ID
18-007
Status last verified
Jun 2019
First submitted
17 Oct 2018
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Telenutrition Counseling in people with Spinal Cord Injury and Obesity, run by Santa Clara Valley Health & Hospital System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight (time frame: Baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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