Trials / Active Not Recruiting
Active Not RecruitingNCT04109586
Diet and Fat Mass After Traumatic Spinal Cord Injury
Preventing Neurogenic Obesity Following Traumatic Spinal Cord Injury
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Sunnaas Rehabilitation Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized clinical controlled trial (RCT) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. The long term goal is to prevent gain of body fat mass and obesity.
Detailed description
Traumatic spinal cord injury (SCI) is a devastating injury resulting from critical incidents like falls, sports- and traffic accidents, demanding lifelong specialist health care services. A major challenge is the prevalence of obesity following metabolic alterations after SCI. Obesity hampers independence and mobility and has a negative impact on quality of life. Accumulation of adipose tissue is reported to be higher than in able-bodied, explaining the high risk of cardiometabolic disease in the SCI population. Food intake is the supreme variable in prevention of obesity after SCI, however there is a paucity in studies investigating nutrition as a measure to prevent and reduce comorbidity. Key questions that remains unanswered are how early adipose tissue accumulates, if nutritional manipulations can prevent obesity and how follow-up can help maintain a healthy lifestyle. In the present PhD-study, we use MRI techniques to quantify changes in body composition in a cohort study the first year after SCI, and we employ a randomized controlled trial to test the efficacy of a nutrition intervention during rehabilitation aiming to prevent obesity. Successful results will be implemented in care-programs at our hospital for those with SCI and similar mobility impairments, with the aim of improving nutrition practice throughout the course of treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Personalized nutritional therapy | Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury |
Timeline
- Start date
- 2019-09-15
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2019-09-30
- Last updated
- 2025-12-26
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT04109586. Inclusion in this directory is not an endorsement.