Specialty: Children, Primary sub-specialty: Diabetes and endocrinology
Conditions
Interventions
Eligible and consenting children with Type 1 diabetes will be randomly assigned to either the STAK-D intervention or the ‘treatment as usual’ control condition (children will be asked to continue with
parents/carers will also be encouraged to access the same website to learn more about lifestyle and physical activity in Type 1 diabetes. Children will be encouraged to practice strategies from the we
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 9-12 years 2. Diagnosis of Type 1 Diabetes for at least 3 months 3. Willingness of child and parent for the child to wear a wrist-worn device
Exclusion criteria
Exclusion criteria: 1. Recurrent hypoglycaemia or consultant concern 2. Inability to communicate in the English language (due to limited resources we are unable to have materials translated into other languages in this feasibility study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Recruitment rate is recorded as the number of eligible participants that consented to participate during the recruitment period. Records will also be kept regarding the number of children screened for entry to the trial. If not admitted to the trial, the reason why the person was ineligible for inclusion will be recorded. Similarly, if eligible, the reason for a person declining to participate will be recorded, if available 2. Pattern of intervention use will be monitored through assessing website traffic data at regular intervals between baseline and eight weeks and between eight weeks and six months 3. User satisfaction with STAK-D (e.g. navigation, ease of use, technical issues) will be assessed by interview at six months 4. Retention rate, defined as the number of participants completing the STAK-D programme including all scheduled follow-up data collection (baseline, eight weeks and six months) compared to the number started 5. Data completion rate is determined by recording the proportion of participants who complete the outcome measures at baseline, eight weeks and six months 6. Feasibility of gathering routinely collected clinic data from patients’ electronic diabetes record (height, weight, glycosylated haemoglobin (HbA1c) level, and insulin dosage) is determined at baseline, eight weeks and six months 7. Occurrence of adverse events related to the intervention (e.g., incidence of hypoglycaemia or hyperglycaemia as a result of the intervention) will be assessed by reviewing patient notes and reviewing patient reports via the website throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Child measures: 1. Self-reported physical activity will be assessed with a 55-item physical activity questionnaire (PAQ) at baseline, eight weeks and six months 2. Self-efficacy for physical activity will be measured using the Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity scale (CSAPPA) at baseline, eight weeks and six months 3. Fear of hypoglycaemia will be assessed using the Children’s Hypoglycemia Fear Survey (CHFS) at baseline, eight weeks and six months 4. Health-related quality of life will be measured using the Child Health Utility 9D (CHU9D) at baseline, eight weeks and six months 5. Clinician-patient communication (frequency and difficulty of physical activity discussions with their diabetes healthcare team) will be measured using a short questionnaire developed specifically for this study at baseline, eight weeks and six months 6. Physical activity will be measured objectively using a Polar Active wrist-worn activity watch (Polar Electro Inc, Lake Success, New York) at baseline, eight weeks and six months 7. Clinical outcome measures will be collected by the diabetes healthcare team and, with consent, will be taken from the child’s clinic notes at baseline, eight weeks and six months, specifically: 7.1. Glycosylated haemoglobin (HbA1c) 7.2. Insulin dosage 7.3. Body composition - Height (cm) and weight (kg) Parent measures: 1. Participant Characteristics will be assessed using a demographic questionnaire to assess ethnic background, family composition, parent(s) education, and parent(s) occupation at baseline 2. Parental fear of hypoglycaemia will be assessed using the parents’ Hypoglycemia Fear Survey (PHFS) at baseline, eight weeks and six months 3. Physical and psychosocial wellbeing of the child, from parent perspective, will be measured using the child health questionnaire for parents (CHQ-PF28) at baseline, eight weeks and six months 4. Number of additional contacts with the diabetes team other than routine clinic | — |
Countries
England, United Kingdom
Outcome results
None listed