Physical Activity Monitoring Paediatric Type 1 Diabetes

NCT03144869 | Completed

• 1 other identifier: CA16015
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes mellitus; physical activity; children; constant glucose monitoring

Outcome Measures

Primary Outcomes (6)

• Recruitment

  Recruitment will be recorded during the recruitment period as the number of eligible participants that consented to participate. The following data will be assessed: number meeting eligibility criteria, reasons for ineligibility, number consenting and reasons for non-participation; demographic profile of participating and nonparticipating (e.g., to assess inclusion of ethnic minority and hard-to-reach groups), and withdrawals (with reasons where available).

  During recruitment (0 months)

• Adherence

  Adherence will refer to the proportion of participants who adhere to the activity monitoring protocol (meet the valid wear-time protocol) and proportion of participants who attend all scheduled activity monitoring sessions with the researcher. Adherence will be monitored by the researcher at baseline, follow-up and throughout the intervention.

  At follow-up (~3 months)

• Retention

  Retention rate will be defined as the number of participants completing the intervention, including all follow-up data collection (follow-up and interview) compared to the number started. Retention will be recorded by the researcher at follow-up and interview.

  At follow-up (~3 months)

• Data completion

  Data completion rate is determined by recording the proportion of participants who complete the outcome measures at baseline and follow-up. To assess data completion, completion of questionnaire measures will be recorded at baseline and follow-up (complete and partial or non-completion with reasons, time to complete). The feasibility of gathering routinely collected data available in patients' clinic notes at baseline and follow-up will be assessed. Feasibility of collecting observational data in this way will be determined if \>85% of our sample have complete clinical records available. Data completion will be recorded by the researcher at baseline and follow-up.

  At baseline (0 months) and follow-up (~3 months)

• Occurrence of adverse events

  ccurrence of adverse events related to the intervention (e.g., severe hypoglycaemia, accident or injury) will be assessed by reviewing patient notes and patient self-report.

  At baseline (0 months), during intervention (0-3 months) and at follow-up (~3 months)

• Acceptability

  User acceptability of research and intervention processes will be assessed by interview with children and parents. Interviews will explore acceptability of i) recruitment, ii) outcome measures, iii) participant burden, iv) the activity monitor and v) feedback sessions to determine appropriateness of the intervention for use in a future trial and clinical practice. Interviews will explore perceptions of change. Interviews will be conducted by a member of the research team who is experienced in qualitative research and who, ideally, has had no direct involvement with the intervention implementation.

  At follow-up (~3 months)

Secondary Outcomes (4)

• Demographics

  At baseline (0 months)

• Clinical information

  At baseline (0 months) and follow-up (~3 months)

• Parental self-efficacy for diabetes management

  At baseline (0 months) and follow-up (~3 months)

• Parental fear of hypoglycaemia

  At baseline (0 months) and follow-up (~3 months)

Study Arms (2)

physical activity monitor only

EXPERIMENTAL

Children will wear a Runscribe accelerometer for two weeks. Runscribe is a small inertial sensor (weight 15g, size 35x25x7.5 mm). It can be attached to the body in several positions (wrist, waist, sacrum, chest, thigh, foot) and is used for monitoring movement. Runscribe does not beep, flash or have a visual display. It will not provide PA feedback to the individuals in real-time, only via a researcher after the data has been downloaded. In this study, we are not wishing to influence children's behaviour by providing PA feedback in real-time. We are trying to establish whether PA monitoring is feasible and acceptable - and further research could go on to explore the use of real-time PA feedback as an educational technique. Phase 1 findings will help to determine: i) method of monitor distribution to participants (post, clinic or in-person), ii) preferred wear position.

Behavioral: physical activity monitor and feedback

physical activity monitor plus constant glucose monitor

EXPERIMENTAL

Children using a personal constant glucose monitor (CGM) or CGM on loan from clinic as part of clinical care will be approached for Arm 2. These children will wear Runscribe at the same time as a CGM. Runscribe and CGM worn over the same 2 week period.

Behavioral: physical activity monitor and feedback

Interventions

physical activity monitor and feedback BEHAVIORAL

Children will wear a Runscribe accelerometer for two weeks (children in Arm 2 will also wear a CGM). Runscribe will measure activity levels. Activity data will be downloaded by a researcher, analysed and graphs of daily activity levels prepared. At the child's next routine clinic appointment, child and parent will have 1:1 session with researcher acting as 'physical activity champion'. Session content will be informed by Phase 1, but will involve educational support around PA (including barriers and facilitators to participation) and individualised feedback on PA level). Individualised feedback will involve review of daily PA graphs - addressing times of high and low activity levels. For participants in Arm 2, there will also be review of daily line graphs showing BG trends. As part of standard clinical care, CGM data gets downloaded at routine clinic appointments and is visible on the patient's clinic notes in daily graph form.

physical activity monitor only; physical activity monitor plus constant glucose monitor

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Sheffield Children's NHS Foundation Trust: collaborator

Study Sites (1)

Sheffield Children's Hospital NHS Foundation Trust

Sheffield, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 16055489 BACKGROUND

• 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.

  PMID: 22180760 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: September 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)