Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000196943
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
19/02/2020
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Association between diet quality, lipid profile and body weight in participants with spinal injury
Scientific title
Association between diet quality, lipid profile and body weight in patients with spinal cord injury
Secondary ID [1] 300448 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord injury 316112 0
Cardiovascular disease 316113 0
Condition category
Condition code
Public Health 314399 314399 0 0
Health promotion/education
Cardiovascular 314400 314400 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 314401 314401 0 0
Other neurological disorders
Injuries and Accidents 314524 314524 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be provided with dietary education and offered menu selection of food choices from a “cardio-diet”. Data will be collected at baseline, every 4 weeks during hospital stay and 6-8 weeks post discharge.
Cardio-metabolic profile data collection include:
Anthropometry – Height, body weight, waist circumference
Biochemistry – Lipid profile (Total cholesterol, HDL, LDL, TG) fasting BGL, HbA1c, CRP, homocysteine, insulin resistance (HOMA-IR)
Clinical – Body composition using bio-impedance spectroscopy (SFB7) and blood pressure
Diet –A validated Food Frequency questionnaire (DHQ III) will be used to quantify pre-morbid/pre-hospital intake data. Dietary intake during admission will be measured using a 3-day food record, representing 2 weekdays and one weekend day. Diet quality will be assessed at each point using Mediterranean diet assessment tool (MEDAS). All recruited patients will be offered the “cardio-diet” menu in line with the Mediterranean diet, low saturated fat with high fruits and vegetables, low salt intake including wholegrains and legumes. Additionally, meals will be tailored using small, regular and large serves based on the energy requirements calculated using spinal cord injury specific guidelines. . Dietary intake will be measured using a 3-day food record, representing 2 weekdays and one weekend day. The form will be completed by either the patient/family and/or the nursing staff.Diet quality as well as compliance will be assessed at baseline and each check point during the intervention period using the validated 14-item Mediterranean Diet Assessment Tool (MEDAS)
Education – 1 x 30 minute group session (week 2) and 2 x 15 minute duration one-on-one tailored nutrition education sessions of 15 minutes duration each at week 4 and week 8 with written handouts will be provided during the 12-week intervention period. Nutrition education will incorporate modules in line with social cognitive theory and protection motivation theory with behaviour change techniques including motivational interviewing, goal-setting and positive reinforcement/feedback in addition to self-monitoring of behaviour. Nutrition education handouts will bee purpose-designed, specifically for this study and education sessions are conducted by the accredited practicing dietitian at all times.
All baseline markers will be tested at periodic intervals of 0, 4, 8, & 12 weeks except for body composition and biochemistry, which will be reviewed at baseline, 12 weeks and post discharge only. If patients are discharged home prior, follow-up will be completed in the community for that period. Community follow-up at ~6-8 weeks post discharge (as 18 weeks’ review or more depending on the time of discharge) will follow all discharges.
The findings will be reported according to the STROBE statement.
Intervention code [1] 316740 0
Prevention
Intervention code [2] 316741 0
Rehabilitation
Intervention code [3] 316742 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322753 0
Diet quality using MEDAS tool
Timepoint [1] 322753 0
Baseline (week 0 as primary timepoint) and at intervals of 4, 8, and 12 weeks and once post discharge from the facility (~6-8 weeks)
Primary outcome [2] 322754 0
Lipid profile
Biochemistry evaluation will be ordered by the medical staff and completed at the facility’s accredited pathology labs as is usually done part of standard care. Fasting blood samples will be taken from patients to measure lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides).Biochemistry review in the community will be arranged by the medical specialist and completed by the patient’s General Practitioner. If patients are discharged home prior, follow-up will be completed in the community for that period.
Timepoint [2] 322754 0
Baseline (primary timepoint), 12 weeks and 6-8 weeks post discharge
Primary outcome [3] 322756 0
Body weight
Body weight will be measured to 0.1kg using Seca 664 wheelchair, digital scales.
Timepoint [3] 322756 0
Baseline (primary timepoint), 4, 8 and 12 weeks and 6-8 weeks post discharge
Secondary outcome [1] 379573 0
Body composition using Bioelectrical impedance analysis
Timepoint [1] 379573 0
Baseline, 12 weeks and 6-8 weeks post discharge
Secondary outcome [2] 379574 0
Waist circumference
Waist circumference will be measured in supine position using the narrowest part of the waist or belly button used as the marker. Stretch-resistant tensiometer or disposable tape measure in centimetres will be used to measure. Nursing staff assistance will be sought as required to enable measurement of all, as required.
Timepoint [2] 379574 0
baseline, 4, 8, 12 weeks and 6-8 weeks post discharge
Secondary outcome [3] 379575 0
Blood pressure
Blood pressure (resting arterial) will be measured by nursing or medical staff and repeated twice in the easily accessible arm when the patient is sitting upright.

Timepoint [3] 379575 0
Baseline, 12 weeks and 6-8 weeks post discharge
Secondary outcome [4] 379576 0
Biochemistry - others (HbA1c)
Biochemistry evaluation will be ordered by the medical staff and completed at the facility’s accredited pathology labs as is usually done part of standard care. Fasting blood samples will be taken from patients to measure during inpatient admission. Biochemistry review in the community will be arranged by the medical specialist and completed by the patient’s General Practitioner. If patients are discharged home prior, follow-up will be completed in the community for that period.
Timepoint [4] 379576 0
Baseline, 12 weeks and 6-8 weeks post discharge
Secondary outcome [5] 380301 0
Biochemistry - others (CRP)
Biochemistry evaluation will be ordered by the medical staff and completed at the facility’s accredited pathology labs as is usually done part of standard care. Fasting blood samples will be taken from patients to measure during inpatient admission. Biochemistry review in the community will be arranged by the medical specialist and completed by the patient’s General Practitioner. If patients are discharged home prior, follow-up will be completed in the community for that period.
Timepoint [5] 380301 0
Baseline, 12 weeks and 6-8 weeks post discharge
Secondary outcome [6] 380302 0
Biochemistry - others (fasting BGL)
Biochemistry evaluation will be ordered by the medical staff and completed at the facility’s accredited pathology labs as is usually done part of standard care. Fasting blood samples will be taken from patients to measure during inpatient admission. Biochemistry review in the community will be arranged by the medical specialist and completed by the patient’s General Practitioner. If patients are discharged home prior, follow-up will be completed in the community for that period.
Timepoint [6] 380302 0
Baseline, 12 weeks and 6-8 weeks post discharge
Secondary outcome [7] 380303 0
Biochemistry - others (homocysteine)
Biochemistry evaluation will be ordered by the medical staff and completed at the facility’s accredited pathology labs as is usually done part of standard care. Fasting blood samples will be taken from patients to measure during inpatient admission. Biochemistry review in the community will be arranged by the medical specialist and completed by the patient’s General Practitioner. If patients are discharged home prior, follow-up will be completed in the community for that period.
Timepoint [7] 380303 0
Baseline, 12 weeks and 6-8 weeks post discharge
Secondary outcome [8] 380304 0
Biochemistry - others (HOMA_IR)
Biochemistry evaluation will be ordered by the medical staff and completed at the facility’s accredited pathology labs as is usually done part of standard care. Fasting blood samples will be taken from patients to measure during inpatient admission. Biochemistry review in the community will be arranged by the medical specialist and completed by the patient’s General Practitioner. If patients are discharged home prior, follow-up will be completed in the community for that period.
Timepoint [8] 380304 0
Baseline, 12 weeks and 6-8 weeks post discharge

Eligibility
Key inclusion criteria
All adult inpatients admitted to the spinal injury rehabilitation unit, with or without existing CVD risk/disease at Royal Rehab consenting to participate will be included in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Community dwelling individuals with spinal cord injury and inpatients in acute care facilities will be excluded from this study.
2. Participants who decline or refuse to participate in the study. Refusal to participate in the study will in no way affect their treatment and these individuals will still receive regular services from the Nutrition and Dietetics team at the facility. These participants also have the liberty to opt for the cardo-diet choice, should they prefer even during non-enrolment into the study.
3. Patients with concurrent or a history of traumatic brain injury with cognitive impairment interfering with their ability to understand the requirements of the study.
4. Patients on enteral feeding or very low energy diet (e.g. Optifast) will be excluded.
5. Patients with grade 2 or above pressure injuries will be excluded.
6. Patients with a pacemaker, those who are either pregnant or breast-feeding will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size – We estimate a sample size of 33 for a moderate effect.
All statistical analyses will be completed using SPSS, version 25 (2017) and the University biostatistician will be consulted as required. Hazard ratios will be calculated using Cox proportional hazards models, adjusting for all cofounders including age, gender, lifestyle factors, co-morbidities etc. Correlation between diet quality and physical activity with CVD risk will be determined using Pearson’s or Spearman’s correlation depending on the type of data. Multiple linear regression analyses will be used to assess the association of diet quality and biochemical parameters. Significance will be set at p<0.05 level.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/02/2020
Actual
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15776 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment postcode(s) [1] 29210 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 304866 0
Hospital
Name [1] 304866 0
Royal Rehab
Country [1] 304866 0
Australia
Primary sponsor type
Individual
Name
Priya Iyer
Address
Priya Iyer
Dietetics Professional Leader
Royal Rehab
235, Morrison Road
Ryde
NSW 2112
Country
Australia
Secondary sponsor category [1] 305205 0
University
Name [1] 305205 0
University of Wollongong
Address [1] 305205 0
School of Medicine
University of Wollongong
NSW 2522
Country [1] 305205 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305275 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305275 0
Ethics committee country [1] 305275 0
Australia
Date submitted for ethics approval [1] 305275 0
10/09/2019
Approval date [1] 305275 0
11/10/2019
Ethics approval number [1] 305275 0
2019/ETH11807

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99850 0
Ms Priya Iyer
Address 99850 0
Royal Rehab
235, Morrison Road
Ryde
NSW 2112
Country 99850 0
Australia
Phone 99850 0
+61 02 98089639
Fax 99850 0
+61 02 98096071
Email 99850 0
[email protected]
Contact person for public queries
Name 99851 0
Priya Iyer
Address 99851 0
Royal Rehab
235, Morrison Road
Ryde
NSW 2112
Country 99851 0
Australia
Phone 99851 0
+61 02 98089639
Fax 99851 0
+61 02 98096071
Email 99851 0
[email protected]
Contact person for scientific queries
Name 99852 0
Priya Iyer
Address 99852 0
Royal Rehab
235, Morrison Road
Ryde
NSW 2112
Country 99852 0
Australia
Phone 99852 0
+61 02 98089639
Fax 99852 0
+61 02 98096071
Email 99852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified patient data used in the publication will be made available.
When will data be available (start and end dates)?
The data will be made available post completion and publication of the study.
Available to whom?
To all researchers/others via public databases (for research purposes, journal provided)
Available for what types of analyses?
To meet the aims of the study protocol.
How or where can data be obtained?
Via emailing the principal investigator with reasonable request. Principal investigator can be contacted via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6757Ethical approval    379198-(Uploaded-04-02-2020-23-44-22)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.