Clinical trial NCT03144869: Physical Activity Monitoring Paediatric Type 1 Diabetes
Official title: Feasibility and Acceptability of Physical Activity Monitoring as an Educational Tool in the Management of Paediatric Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes mellitus
physical activity
children
constant glucose monitoring
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Sheffield Children's NHS Foundation Trust
First posted: 2017-05-09
Enrollment: 13
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM), yet being physically active can have unwanted side effects due to fluctuations in blood glucose (BG) level. Children and parents need support to help understand the relationship between PA and BG level, and how to use PA as a vehicle to better manage the condition. Using PA monitoring could help HCPs raise awareness about PA, discuss PA and facilitate diabetes management. This research will explore the feasibility and acceptability of PA monitoring as a clinical tool to help the management of paediatric T1DM.

Detailed description: Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM) such as improved diabetes control, lipid profile and body composition, yet activity levels are low. The unpredictable nature of children's everyday activity causes fluctuations in blood glucose (BG) level. Low and high BG level are side-effects of PA, have significant symptoms and can cause a range of chronic complications. Parents typically have responsibility for diabetes management in preadolescent children and perceive PA as a challenge due to constant concerns about BG levels (Quirk et al., 2015).

Children and parents need support to help understand the relationship between PA and BG control and how to use PA as a vehicle through which to better manage the condition. T1DM healthcare professionals (HCPs) perceive a lack of i) competence, ii) confidence and iii) time to provide PA advice and education in the clinical setting. HCPs perceive a need for evidence-based resources to facilitate PA discussion, education and promotion (Quirk et al., 2015). Physical activity monitoring is already a widely recognised and accepted tool, with potential utility in paediatric diabetes.

One such approach could be that HCPs graphically convey children's PA levels and use this to raise awareness and promote discussion about daily PA level. In those using constant glucose monitoring devices, daily BG values could be graphically documented to help explain the relationship between PA and BG level. These devices have shown acceptability among children with T1DM. However, whether they can facilitate PA discussion and education is unknown.

This research will explore parents, children and HCPs' perceptions of PA monitoring in clinical practice. A PA monitoring programme will be developed, implemented in a small cohort of children with T1DM and evaluated for feasibility and acceptability. In the future, 'physical activity clinical champions' could be trained to use activity monitoring for PA education and promotion in clinic settings.

Eligibility criteria: Inclusion Criteria:

* Arm 1 Children with type 1 diabetes Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear activity monitor
* Arm 2 Children with type 1 diabetes using a personal CGM OR CGM on loan from clinic as part of clinical care Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear an activity monitor

Exclusion Criteria:

-

Primary outcomes:
measure: Recruitment
timeFrame: During recruitment (0 months)
measure: Adherence
timeFrame: At follow-up (~3 months)
measure: Retention
timeFrame: At follow-up (~3 months)
measure: Data completion
timeFrame: At baseline (0 months) and follow-up (~3 months)
measure: Occurrence of adverse events
timeFrame: At baseline (0 months), during intervention (0-3 months) and at follow-up (~3 months)
measure: Acceptability
timeFrame: At follow-up (~3 months)
Secondary outcomes:
measure: Demographics
timeFrame: At baseline (0 months)
measure: Clinical information
timeFrame: At baseline (0 months) and follow-up (~3 months)
measure: Parental self-efficacy for diabetes management
timeFrame: At baseline (0 months) and follow-up (~3 months)
measure: Parental fear of hypoglycaemia
timeFrame: At baseline (0 months) and follow-up (~3 months)
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital NHS Foundation Trust
Study officials:
References:
citation: Streisand R, Swift E, Wickmark T, Chen R, Holmes CS. Pediatric parenting stress among parents of children with type 1 diabetes: the role of self-efficacy, responsibility, and fear. J Pediatr Psychol. 2005 Sep;30(6):513-21. doi: 10.1093/jpepsy/jsi076. Epub 2005 Mar 3.
citation: Gonder-Frederick L, Nyer M, Shepard JA, Vajda K, Clarke W. Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents. Diabetes Manag (Lond). 2011;1(6):627-639. doi: 10.2217/DMT.11.60.