Clinical trial NCT05468437: Telenutrition for Individuals With SCI
Official title: Telenutrition to Improve Cardiometabolic Health and Quality of Life Among Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Obesity
Cardiometabolic Syndrome
Keywords: Spinal Cord injury
Obesity
Cardiometabolic
cardiovascular
bowel
bladder
nutrition
telehealth
Lead sponsor: Santa Clara Valley Health & Hospital System
Sponsor class: OTHER
Collaborators: name: San Jose State University
name: University of California, San Francisco
First posted: 2022-07-21
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a wait-list control study. Individuals in the immediate treatment group will receive the intervention in the first 3 months, followed by a 3 month durability phase. The delayed treatment group will receive the intervention in the second 3 month period.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Healthy Eating Index (HEI) scores
timeFrame: 0, 3 and 6 months
Secondary outcomes:
measure: Blood lipid profile
timeFrame: 0, 3 and 6 months
measure: HbA1C
timeFrame: 0, 3 and 6 months
measure: Vitamin D
timeFrame: 0, 3 and 6 months
measure: high-sensitivity C-reactive protein [hs-CRP]
timeFrame: 0, 3 and 6 months
measure: Body Mass Index (BMI)
timeFrame: 0, 3 and 6 months
measure: Waist circumference
timeFrame: 0, 3 and 6 months
measure: Fat percent
timeFrame: 0, 3 and 6 months
measure: Bowel function
timeFrame: 0, 3 and 6 months
measure: Bladder function
timeFrame: 0, 3 and 6 months
measure: Quality of Life (Qol) measure
timeFrame: 0, 3 and 6 months
measure: Frequency of Autonomic Dysreflexia (AD)
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
Study officials:
affiliation: Santa Clara Valley Medical Center
name: Kazuko Shem, MD
role: PRINCIPAL_INVESTIGATOR
References: