Spinal Cord InjuriesNCT03025048
A Holistic Dietary Intervention for Persons With Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Sunnaas Rehabilitation Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- A holistic dietary intervention for persons with spinal cord injury
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With long-standing spinal cord injury (> 2 years after injury)
Who may be able to join
- >18 years
- Long-standing Spinal Cord Injury (> 2 years after injury)
- Motivated for lifestyle change
Who cannot join
None listed.
About this study
Official title: 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.
Read more
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).
- Conditions
- Spinal Cord Injuries
- Being tested
- A holistic dietary intervention for persons with spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A holistic dietary intervention for persons with spinal cord injuryBehavioural
A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Measured: Short-term: 9 weeks
Secondary outcomes (1)
Diet behaviour
Measured: Short-term: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Bjørg Slettahjell, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025048
- Sponsor's protocol ID
- 2016/1477-6
- Status last verified
- Apr 2019
- First submitted
- 16 Jan 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT: A Holistic Dietary Intervention for Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03025048
- Acronym / sponsor ID
- 2016/1477-6
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With long-standing spinal cord injury (> 2 years after injury)
Key inclusion criteria (3 listed)
- >18 years
- Long-standing Spinal Cord Injury (> 2 years after injury)
- Motivated for lifestyle change
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A holistic dietary intervention for persons with spinal cord injuryA lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions | Behavioural | – |
Primary outcome
Body composition
Time frame: Short-term: 9 weeks
1 secondary outcome
Diet behaviour
Time frame: Short-term: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Sunnaas Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Short-term: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.