Clinical trial

Telenutrition for Individuals With SCI

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05468437

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionSpinal Cord Injuries, Obesity, Cardiometabolic Syndrome

Full registry 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

Treatments and study arms

Telenutrition

Behavioral

Nutrition education and individualized nutrition counseling will be done with a Registered Dietitian via video-conferencing 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 counseling 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. You will be involved in developing personal nutrition goals and the dietitian will help you address barriers to meeting your goals and provide individualized feedback to improve and maintain your nutrition. Telenutrition appointments will maintain privacy and will not be recorded.

Primary outcomes

Healthy Eating Index (HEI) scores0, 3 and 6 months

HEI scores from participants' individual dietary intakes at different time-points of evaluations (baseline/pre-intervention, end of 3 months from baseline, end of 6 months from baseline) will be reported. Changes in HEI scores following intervention will be compared to pre-intervention baseline scores (within group comparison) as well as scores from the waitlisted group (between group comparison) and reported accordingly. In addition, longer-term changes in HEI scores (for individuals from the immediate intervention group) during the durability phase will also be reported.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Santa Clara Valley Medical Center🇺🇸 San Jose, California, United States