NCT03025048

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

January 16, 2017

Last Update Submit

April 27, 2019

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

  • Body composition

    Short-term: 9 weeks

Secondary Outcomes (1)

  • Diet behaviour

    Short-term: 9 weeks

Interventions

A holistic dietary intervention for persons with spinal cord injuryBEHAVIORAL

A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered dietitian, MSc

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 19, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share