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NCT03025048 Clinical Trial

A Holistic Dietary Intervention for Persons With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:
PILOT: A Holistic Dietary Intervention for Persons With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03025048
Other study ID # 2016/1477-6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date May 2017

Study information
Verified date April 2019
Source Sunnaas Rehabilitation Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

People with spinal cord injury are at increased risk for overweight and obesity, type 2 diabetes, cardiovascular disease and decreased quality of life compared With able bodied.

This pilot aims to assess the impact of a nutrition intervention that combines several methods to help people change their lifestyle.

The pilot project combines individual interviews and personal lifestyle goals (diet) with group classes for people with long-standing spinal cord injury.

In addition to nutrition theory and practical exercises for diet-planning, motivational interviewing and mindfullness are incorporated into the course. The course is interdisciplinary, but is led primarily by a dietitian. Data is collected before the course starts and right after the 9-week course ends. The measurements involves self-perceived quality of life, food diary, weight, waist circumference and body composition (measured by BIA and DXA).

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date May 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- >18 years

- Long-standing Spinal Cord Injury (> 2 years after injury)

- Motivated for lifestyle change

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• A holistic dietary intervention for persons with spinal cord injury
A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sunnaas Rehabilitation Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Body composition Short-term: 9 weeks
Secondary Diet behaviour Short-term: 9 weeks
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