None listed
Conditions
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.
Interventions
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 specialise
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.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
1 Years to 17 Years
Healthy volunteers
No
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
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
Outcome results
None listed