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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05468437
Other study ID # 21-038
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 13, 2022
Est. completion date September 30, 2026

Study information

Verified date January 2024
Source Santa Clara Valley Health & Hospital System
Contact Kazuko Shem, MD
Phone 800-352-1956
Email kazuko.shem@hhs.sccgov.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date September 30, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Telenutrition
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.

Locations

Country Name City State
United States Santa Clara Valley Medical Center San Jose California

Sponsors (3)

Lead Sponsor Collaborator
Santa Clara Valley Health & Hospital System San Jose State University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Blood lipid profile Lipid profile constituting of Triglycerides (TG), Total Cholesterol (TC); low-density lipoprotein (LDL) and High-density lipoprotein (HDL)- values (all expressed as mg/dL) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes in values will also be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary HbA1C Blood values of HbA1C (expressed as percentage) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in percent values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Vitamin D Blood values of Vitamin D (expressed as ng/mL) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary high-sensitivity C-reactive protein [hs-CRP] Blood values of hs-CRP (expressed as mg/L) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group) 0, 3 and 6 months
Secondary Body Mass Index (BMI) Multiple measures (weight in kg and height in meters) will be aggregated to arrive at one reported BMI values (expressed as kg/m^2). BMI values will be reported at all time-points of evaluations (baseline, end of 3 months and at the end of 6 months). Absolute changes in values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Waist circumference Waist circumference (in inches) will be reported at all time-points of evaluations (baseline, end of 3 months and at the end of 6 months). Absolute changes in values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Fat percent Fat percent (%) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in percentage values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Bowel function Changes in bowel function (as determined by the Simon Fraser University (SFU) bowel survey questions based on a rating scale) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in perceived rating will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Bladder function Changes in bladder function (as determined by the SF-Qualiveen survey expressed as a score) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in scores will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Quality of Life (Qol) measure Changes in Qol [using the Satisfaction With Life Scale (SWLS) survey based on a rating scale) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in perceived ratings will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
Secondary Frequency of Autonomic Dysreflexia (AD) Changes in frequency of AD (as determined by the SFU AD survey questions expressed on a 5-point likert scale) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in rating will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group). 0, 3 and 6 months
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