Obesity Clinical Trial
Official title:
Telenutrition to Improve Cardiometabolic Health and Quality of Life Among Individuals With Spinal Cord Injury
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Santa Clara Valley Medical Center | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Santa Clara Valley Health & Hospital System | San Jose State University, University of California, San Francisco |
United States,
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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