Telenutrition for Individuals With SCI

Santa Clara Valley Health & Hospital System

Status: Enrolling

Conditions: Spinal Cord Injuries; Cardiometabolic Syndrome; Obesity

Treatments: Behavioral: Telenutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05468437

21-038

Details and patient eligibility

About

This study will provide nutrition counseling via FaceTime on an iPad to persons with traumatic spinal cord injury (SCI) who are overweight or obese and are at least one-year post-injury. Nutrition counseling may help participants to develop eating behaviors that match the participants' needs and help improve heart health. The purpose of this project is to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. This study will require 3 in person visits that are about 3 months apart. The total length of the study is about 6 months and includes 3 months of telenutrition counseling.

Full description

The first phase of this study will include screening the participants' medical record for study eligibility. If potentially eligible, participants will partake in a secondary in-person screening assessment involving a fasting blood draw and weight, height, body fat, and waist circumference measurements. After the team receives the screening results and if participants continue to remain eligible, the second phase of the study (described below) will begin.

Following screening, participants will be enrolled into the 6-month study. Half of the enrolled participants will be scheduled for telenutrition counselling within the first three months of the study period. This group is called the "immediate treatment group". The other half will receive telenutrition counselling in the second three-month period. This group is called the "delayed treatment group". Participants will be informed which group they are assigned to and provided with details of the care that they will receive shortly after the screening phase is completed. Participants will have 50% chance of being assigned to the immediate treatment group and 50% chance of being assigned to the delayed treatment group.

Both groups will receive the same nutrition education and individualized nutrition counselling via videoconferencing with iPad FaceTime, which is aimed to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. The telenutrition counselling consists of 6 sessions that are scheduled approximately 2 weeks apart. The first session will last approximately 1 hour, while sessions 2-6 will last approximately 30mins. During these sessions, the Registered Dietitian will share nutrition education tailored towards people with SCI. Participants will be involved in developing personal nutrition goals and the dietitian will help address barriers to meeting goals and provide individualized feedback to improve and maintain their nutrition. Telenutrition appointments will maintain privacy and will not be recorded.

To help participate in telenutrition sessions and complete the required assessments, each participant will receive an iPad mini with a 6-month data plan. Once study participation is complete, the investigators will stop the data plan but participants will get to keep the iPads. There are 3 outcome assessment spaced 3 months apart (baseline, short-term, and intermediate term). Each will include the same outcome assessments involving surveys, body measurements, and a blood draw.

Enrollment: 96 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individuals with traumatic SCI
2. At least 1-year post-injury
3. Age 20 years of age or older
4. BMI > 22 kg/m2 at enrollment
5. Proficiency in English or Spanish
6. Living at home or in a private home setting (i.e., not an extended care facility) in the state of California
7. Able / willing to come to SCVMC for in-person assessments
8. Primarily a wheelchair user (>40 hours per week)
9. Able to use, or learn how to use, an iPad
10. Possess adequate decision-making capacity to provide independent informed consent

Exclusion criteria

1. Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury)
2. Current self-reported pregnancy
3. Other medical condition requiring a strict specialized diet (e.g., renal failure, diabetes)
4. Participation in another diet program (e.g., Jenny Craig, Weight Watchers, clinic-based program) and/or participated in another diet program within the past 6 months
5. Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
6. Receiving enteral nutrition
7. Individuals without a primary care physician
8. HbA1c >7% (these individuals would need to be treated with metformin or other anti-diabetic medication and the intervention would have to be significantly altered for them)
9. Individuals who are in law enforcement custody

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Immediate treatment

Experimental group

Description:

Three months of treatment followed by a 3 month durability phase

Treatment:

Behavioral: Telenutrition

Delayed Treatment

Experimental group

Description:

A 3 month waitlist period followed by 3 months of treatment

Treatment:

Behavioral: Telenutrition