Telenutrition in Spinal Cord Injury

NCT03714217 | Completed

• 1 other identifier: 18-007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Obesity

Keywords

Spinal Cord Injury; Obesity; Telenutrition

Outcome Measures

Primary Outcomes (3)

• Change in weight

  Weight in kg

  Baseline, 3 months

• Change in height

  Height in cm

  Baseline, 3 months

• Change in waist circumference

  Waist circumference in cm

  Baseline, 3 months

Secondary Outcomes (1)

• Change in Life Satisfaction Index-A

  Baseline, 3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Telenutrition counseling

Behavioral: Telenutrition Counseling

Interventions

Telenutrition Counseling BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Santa Clara Valley Health & Hospital System: lead

Study Sites (1)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Obesity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kazuko Shem, MD

  Santa Clara Valley Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: July 3, 2018
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: September 21, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)