Obesity and Obesity-related Medical Conditions, Spinal Cord Injury, Chronic
Conditions
Keywords
spinal cord injuries, obesity, insulin resistance
Brief summary
The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity. The main question it aims to answer is: Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance? Participants will: Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet. Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.
Detailed description
A mixed study design will be conducted to test the effectiveness of modified DPP-diet for SCI on body composition and insulin sensitivity before and after the intervention, and the sustained changes in both outcomes at a follow up visit 9 weeks after completion of the program. Qualitative design will be conducted to obtain participants input on the barriers and facilitators in initiating and implementing a sustainable modified DPP-diet for future clinical application on community dwelling individuals with SCI. 20 adults who have had diagnosis of SCI will be recruited for the study. All of them will undergo the modified DPP-diet as an intervention, and outcome measures collected before and after the intervention will be compared within subjects. Of the 20 participants, 10 of them will undergo modified DPP-diet upon enrollment, and the other 10 will wait for nine weeks before undergoing modified DPP-diet. Fasting blood draw and body composition measurements will be collected at three time points for the 10 participants starting modified DPP-diet upon enrollment: tpre, tpost, and tfollow-up. The same set of data will be collected at four time points for the 10 participants with a 9-week waiting period before starting the modified DPP-diet: t0, tpre, tpost, and tfollow-up. Qualitative study comprised of open-ended, semi-structured interviews will be provided for all 20 participants at the three time points: tpre, tpost, and tfollow-up.
Interventions
OTHERTelehealth with dietician
9 weeks of telehealth visit with dietician using the DPP diet modules
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age 18-65 years old * have had SCI for more than one year * not independently ambulatory * primarily uses a wheelchair for mobility * community-dwelling * without comorbidities listed in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body fat composition | from enrollment to 9 weeks after completion of the modified DPP-diet program | Whole body fat percentage from dual-energy X-ray absorptiometry scan. The unit will be %, with higher value indicating larger amount of body fat within an individual. |
| Homeostatic Model Assessment 2 for Insulin Resistance (HOMA2-IR) | from enrollment to 9 weeks after completion of the modified DPP-diet program | An insulin resistance index calculated from fasting glucose (mmol/l) and insulin (μU/ml) level from blood draw. The HOMA2-IR will be calculated using the formula: HOMA2-IR = (Fasting Insulin (μU/ml) \* Fasting Glucose (mmol/L)) / 22.5. |
Countries
United States
Contacts
CONTACTYi-Ting Tzen
Outcome results
None listed