A Holistic Dietary Intervention for Persons With Spinal C... | NCT03025048

Studies
A Holistic Dietary Intervention for Persons With Spinal Cord Injury

NCT03025048

Sponsor

Sunnaas Rehabilitation Hospital

Status

Completed

Last Update Posted

Apr 30, 2019Actual

Enrollment

13Actual

Phase

Not provided

Conditions

Spinal Cord Injuries

Interventions

A holistic dietary intervention for persons with spinal cord injury

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 16, 2017

First Submission Date that Met QC Criteria

Jan 18, 2017

First Posted Date

Jan 19, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2019

Last Update Posted Date

Apr 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanne Bjørg Slettahjell, Registered dietitian, MSc, Sunnaas Rehabilitation HospitalPrincipal Investigator

Lead Sponsor

Sunnaas Rehabilitation HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A holistic dietary intervention for persons with spinal cord injury	Behavioral	A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions

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

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided