A Holistic Dietary Intervention for Persons With Spinal Cord Injury

April 27, 2019 updated by: Hanne Bjørg Slettahjell, Sunnaas Rehabilitation Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients With long-standing spinal cord injury (> 2 years after injury)

Description

Inclusion Criteria:

  • >18 years
  • Long-standing Spinal Cord Injury (> 2 years after injury)
  • Motivated for lifestyle change

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: Short-term: 9 weeks
Short-term: 9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Diet behaviour
Time Frame: Short-term: 9 weeks
Short-term: 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnaas Rehabilitation Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1477-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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