Diet and Fat Mass After Traumatic Spinal Cord Injury

Sunnaas Rehabilitation Hospital

Status: Active, not recruiting

Conditions: Spinal Cord Injuries; Obesity; Metabolic Disease

Treatments: Behavioral: Personalized nutritional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04109586

REK 2017/2443

Details and patient eligibility

About

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.

Full 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

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Traumatic spinal cord injury
• Levels C1-L2
• American Spinal Injury Association (ASIA) Impairments Scale (AIS) A-D

Exclusion criteria

• Glasgow Coma Scale score (GCS) equal to or lower than 13
• Below 18 years of age
• Medical issues like impaired cognitive function, progressive disorders and co-morbidities.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Personalized nutrition therapy

Experimental group

Description:

Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury

Treatment:

Behavioral: Personalized nutritional therapy

Standard treatment

No Intervention group

Description:

Standard treatment includes dietitian-led group session on nutrition after SCI and patient visits / consultations on request from doctor.