NCT05468437

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jun 2022Sep 2026

Study Start

First participant enrolled

June 13, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3.6 years

First QC Date

June 21, 2022

Last Update Submit

May 13, 2025

Conditions

Spinal Cord InjuriesObesityCardiometabolic Syndrome

Keywords

Spinal Cord injuryObesityCardiometaboliccardiovascularbowelbladdernutritiontelehealth

Outcome Measures

Primary Outcomes (1)

  • Healthy Eating Index (HEI) scores

    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.

    0, 3 and 6 months

Secondary Outcomes (11)

  • Blood lipid profile

    0, 3 and 6 months

  • HbA1C

    0, 3 and 6 months

  • Vitamin D

    0, 3 and 6 months

  • high-sensitivity C-reactive protein [hs-CRP]

    0, 3 and 6 months

  • Body Mass Index (BMI)

    0, 3 and 6 months

  • +6 more secondary outcomes

Study Arms (2)

Immediate treatment

EXPERIMENTAL

Three months of treatment followed by a 3 month durability phase

Behavioral: Telenutrition

Delayed Treatment

EXPERIMENTAL

A 3 month waitlist period followed by 3 months of treatment

Behavioral: Telenutrition

Interventions

TelenutritionBEHAVIORAL

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.

Delayed TreatmentImmediate treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury)
  • Current self-reported pregnancy
  • Other medical condition requiring a strict specialized diet (e.g., renal failure, diabetes)
  • 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
  • Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
  • Receiving enteral nutrition
  • Individuals without a primary care physician
  • 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)
  • Individuals who are in law enforcement custody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Kazuko Shem, MD

    Santa Clara Valley Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kazuko Shem, MD

CONTACT

800-352-1956kazuko.shem@hhs.sccgov.org

Cria-May Khong

CONTACT

800-352-1956cria-may.khong@hhs.sccgov.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

July 21, 2022

Study Start

June 13, 2022

Primary Completion

January 1, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

US(1)