Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000167965
Ethics application status
Approved
Date submitted
25/01/2020
Date registered
17/02/2020
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Nutrition and Optimising Wellbeing Program (SNOW-P) for weight management in Duchenne muscular dystrophy: Feasibility and pilot study
Scientific title
Supporting Nutrition and Optimising Wellbeing Program (SNOW-P) for weight management in Duchenne muscular dystrophy: Feasibility and pilot study
Secondary ID [1] 300329 0
Nil
Universal Trial Number (UTN)
Trial acronym
SNOW-P for weight management in DMD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Duchenne muscular dystrophy 315939 0
Obesity 315940 0
Condition category
Condition code
Neurological 314208 314208 0 0
Other neurological disorders
Diet and Nutrition 314209 314209 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a family-focussed lifestyle, nutrition and well being weight management program. This program is based on standard practice and clinical practice guidelines for weight management for children and adolescents. The intervention has been co-designed by parents of children with Duchenne muscular dystrophy (DMD) and neuromuscular clinicians.

The intervention will be delivered via an Australian paediatric neuromuscular clinic. The intervention will include sessions with a dietitian specialised in paediatric weight management. Sessions will be a combination of face-to-face and phone or video calls, at the participants discretion. Sessions will be conducted weekly over a 6 week intervention period. There will be a 6 week post-intervention period with 12 weeks follow up in total.

The program outline is as follows:
* Session 1 (wk 0) - baseline measures & dietetic counselling session (90 mins)
* Review 1 (wk 1) - brief review via phone or face-to-face (20 mins)
* Session 2 (wk 2) - dietetic counselling session via phone or face-to-face (60 mins)
* Review 2 (wk 3) - brief review via phone or face-to-face (20 mins)
* Session 3 (wk 4) - dietetic counselling session via phone or face-to-face (60 mins)
* Review 3 (wk 5) - brief review via phone or face-to-face (20 mins)
* Session 4 (wk 6) - outcome measures & dietetic counselling session (90 mins)
* Session 5 (wk 12) - outcome measures (30 mins)

Dietetic counselling session will be individual and tailored to each family and will include nutrition education and goal setting. Written resources will also be provided to participants and their families on: nutrition topics, managing appetite, mindfulness, recipe ideas and nutrition supplements. Resources that are readily available from internet sources will be used. Families will also have access to online support from the dietitian.
Intervention code [1] 316606 0
Lifestyle
Intervention code [2] 316646 0
Behaviour
Comparator / control treatment
This is a single arm study with no control comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322639 0
Feasibility and acceptability (composite primary outcome) assessed using a post-program questionnaire. The questionnaires have been specifically designed for this study.
Timepoint [1] 322639 0
Study completion or time of withdrawal from the study.
Secondary outcome [1] 379142 0
Weight (kg) measured using chair scales for ambulant participants and hoist or wheelchair scales for non-ambulant participants.
Timepoint [1] 379142 0
Baseline, week 6, week 12
Secondary outcome [2] 379143 0
BMI (kg/m2) calculated using weight and height. Weight (kg) measured using chair scales for ambulant participants and hoist or wheelchair scales for non-ambulant participants. Height (m) will be measured using a stadiometer for ambulatory participants or estimated from ulnar length for non-ambulatory participants.
Timepoint [2] 379143 0
Baseline, week 6, week 12
Secondary outcome [3] 379144 0
Timed 10 metre walk/run (secs)
Timepoint [3] 379144 0
Baseline, week 6, week 12
Secondary outcome [4] 379145 0
Timed supine-to-stand (secs)
Timepoint [4] 379145 0
Baseline, week 6, week 12
Secondary outcome [5] 379146 0
Time to stack 5 cans (secs)
Timepoint [5] 379146 0
Baseline, week 6, week 12
Secondary outcome [6] 379147 0
Daily step count, number of days activity tracker worn (composite secondary outcome)
Timepoint [6] 379147 0
Week 12
Secondary outcome [7] 379148 0
Diastolic and systolic blood pressure (mmHg) (composite secondary outcome) measured using bench-top sphygmomanometer.
Timepoint [7] 379148 0
Baseline, week 6, week 12
Secondary outcome [8] 379149 0
PedsQL DMD
Timepoint [8] 379149 0
Baseline, week 6, week 12
Secondary outcome [9] 379150 0
Patient-reported fatigue global rating of change
Timepoint [9] 379150 0
Week 6, week 12
Secondary outcome [10] 379151 0
Dietary intake measure using a 3-day food diary. Dietary intake will be assessed by a dietitian based on the Australian Guide to Healthy Eating for food groups and using FoodWorks food analysis software for macro- and micro-nutrient software.
Timepoint [10] 379151 0
Baseline, week 6, week 12

Eligibility
Key inclusion criteria
• Has genetic or muscle biopsy confirmed diagnosis of DMD
• Is below the age of 18 years at the time of enrolment
• Is above a healthy weight as classified as a BMI z-score at or greater than 1.64 (equivalent to BMI at or greater than 97th percentile) according to the CDC BMI-for-age male growth charts
• Provide a signed and dated informed consent form and/or has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf
Minimum age
1 Years
Maximum age
17 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Is enrolled in any other interventional study
• Documented significant illness that may contraindicate participation in a weight management program e.g. undergoing treatment for cancer, inpatient admission for acute illness
• Currently undergoing treatment for a clinical eating disorder
• Child/adolescent or parent with poor level of spoken English such that the intervention program cannot be delivered
• Current enrolment in a formal weight management program e.g. attends appointments at a specialist weight management clinic

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Statistical methods / analysis
This is a pilot study and not powered for statistical changes in parameters.

Baseline characteristics will be presented for all participants eligible for analysis and will not be stratified. The difference in weight, BMI, 10m walk/run time, supine-to-stand time, can stacking exercise time, systolic and diastolic blood pressure, PedsQL DMD and dietary intake between baseline and week 6 and week 12 will be assessed using a repeated measures ANOVA or a non-parametric equivalent and be presented as mean change with standard deviation or median change with inter-quartile range.

Global Rating of Change responses will be reported frequencies (categorical data) at week 6 and week 12. Step count will be reported as a weekly mean across each week of the intervention and follow-up periods, no statistical analysis will be performed for step-count.

Post-program and withdrawal questionnaires will be analysed as frequencies for categorical data. Open-ended responses for the post-program and withdrawal questionnaires will not be formally analysed, however quotes may be used in the dissemination of findings and to inform future research studies.

Data will be analysed with SPSS software (IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp). For all analysis a p-value of <0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/02/2020
Actual
Date of last participant enrolment
Anticipated
27/05/2020
Actual
Date of last data collection
Anticipated
25/11/2020
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15688 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 29107 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 304754 0
University
Name [1] 304754 0
Monash University
Country [1] 304754 0
Australia
Funding source category [2] 304869 0
Hospital
Name [2] 304869 0
The Royal Children's Hospital
Country [2] 304869 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Nutrition, Dietetics and Food
Monash University
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road,
Notting Hill VIC 3168
Australia
Country
Australia
Secondary sponsor category [1] 305109 0
Hospital
Name [1] 305109 0
The Royal Children's Hospital
Address [1] 305109 0
The Royal Children's Hospital Melbourne
50 Flemington Road Parkville Victoria 3052
Country [1] 305109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305172 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 305172 0
The Royal Children's Hospital Melbourne
50 Flemington Road Parkville Victoria 3052
Ethics committee country [1] 305172 0
Australia
Date submitted for ethics approval [1] 305172 0
12/11/2019
Approval date [1] 305172 0
20/12/2019
Ethics approval number [1] 305172 0
HREC/58876/RCHM-2019

Summary
Brief summary
This is a single-arm, uncontrolled feasibility and pilot study of a lifestyle weight management program for Duchenne muscular dystrophy (DMD). The aims of this study are to:
* assess feasibility and acceptability of SNOW-P
* determine the impact of SNOW-P on: weight, BMI, physical function, physical activity level, blood pressure, quality of life, fatigue, dietary intake and adverse events

This study will recruit young people with DMD who have obesity.

The expected outcomes for this study will be improved understanding of how to manage obesity in DMD and improved nutrition and wellbeing for young people after participating in a weight management program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99486 0
Dr Zoe Davidson
Address 99486 0
Department of Nutrition, Dietetics and Food
Monash University
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road,
Notting Hill VIC 3168
Australia
Country 99486 0
Australia
Phone 99486 0
+61 3 9902 4263
Fax 99486 0
Email 99486 0
[email protected]
Contact person for public queries
Name 99487 0
Dr Zoe Davidson
Address 99487 0
Department of Nutrition, Dietetics and Food
Monash University
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road,
Notting Hill VIC 3168
Australia
Country 99487 0
Australia
Phone 99487 0
+61 3 9902 4263
Fax 99487 0
Email 99487 0
[email protected]
Contact person for scientific queries
Name 99488 0
Dr Zoe Davidson
Address 99488 0
Department of Nutrition, Dietetics and Food
Monash University
Be Active Sleep Eat (BASE) Facility
Level 1, 264 Ferntree Gully Road,
Notting Hill VIC 3168
Australia
Country 99488 0
Australia
Phone 99488 0
+61 3 9902 4263
Fax 99488 0
Email 99488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not shared for this pilot trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6603Informed consent form  [email protected]



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.