Feasibility of an Online Intervention (STAK-D) to Promote Physical Activity in Children with Type 1 Diabetes: Protocol for a Randomised Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2016 Dec 10

PMID 27931254

Citations 6

Authors

Holly Blake

Helen Quirk

Paul Leighton

Tabitha Randell

James Greening

Boliang Guo

Cris Glazebrook

Affiliations

Soon will be listed here.

Abstract

Background: Regular physical activity has important health benefits for children with type 1 diabetes mellitus (T1DM), yet children and their parents face barriers to participation such as lack of self-efficacy or concerns around hypoglycaemia. Multimedia interventions are useful for educating children about their health and demonstrate potential to improve children's health-related self-efficacy, but few paediatric clinics offer web-based resources as part of routine care. The Steps to Active Kids with Diabetes (STAK-D) programme is an online intervention grounded in psychological theory (social cognitive theory) and informed by extensive preliminary research. The aim of the programme is to encourage and support safe engagement with physical activity for children with T1DM. The aim of this research is to explore the feasibility of delivering the STAK-D programme to children aged 9-12 years with T1DM, and to assess the feasibility of further research to demonstrate its clinical and cost-effectiveness.

Methods: Up to 50 children aged 9-12 years with T1DM and their parents will be recruited from two paediatric diabetes clinics in the UK. Child-parent dyads randomised to the intervention group will have access to the intervention website (STAK-D) and a wrist-worn activity monitor for 6 months. The feasibility of intervention and further research will be assessed by rate of recruitment, adherence, retention, data completion and adverse events. Qualitative interviews will be undertaken with a subsample of children and parents (up to 25 dyads) and health care professionals (up to 10). Health outcomes and the feasibility of outcome measurement tools will be assessed. These include self-efficacy (CSAPPA), objective physical activity, self-reported physical activity (PAQ), fear of hypoglycaemia (CHFS; PHFS), glycaemic control (HbA1c), insulin dose, Body Mass Index (BMI), health-related quality of life (CHU9D; CHQ-PF28), health service use and patient-clinician communication. Assessments will be taken at baseline (T0), 8 weeks (T1) and at 6-month follow-up (T2).

Discussion: The goal of this feasibility trial is to assess the delivery of STAK-D to promote physical activity among children with T1DM, and to assess the potential for further, definitive research to demonstrate its effectiveness. Results will provide the information necessary to design a larger randomised controlled trial and maximise the recruitment rate, intervention delivery and trial retention.

Trial Registration: ISRCTN, ISRCTN48994721 . Registered on 28 October 2016.

Citing Articles

Early Nutritional Intervention to Promote Healthy Eating Habits in Pediatric Oncology: A Feasibility Study.

Belanger V, Delorme J, Napartuk M, Bouchard I, Meloche C, Curnier D Nutrients. 2022; 14(5).

PMID: 35267999 PMC: 8912879. DOI: 10.3390/nu14051024.

CHU9D Normative Data in Peruvian Adolescents.

Palacios-Cartagena R, Pastor-Cisneros R, Adsuar J, Perez-Gomez J, Garcia-Gordillo M, Mendoza-Munoz M J Pers Med. 2021; 11(12).

PMID: 34945744 PMC: 8704949. DOI: 10.3390/jpm11121272.

Online recruitment of a non-help-seeking sample for an internet intervention: Lessons learned in an alcohol-exposed pregnancy risk reduction study.

MacDonnell K, Cowen E, Cunningham D, Ritterband L, Ingersoll K Internet Interv. 2019; 17:100240.

PMID: 30963031 PMC: 6434331. DOI: 10.1016/j.invent.2019.100240.

SKIP (Supporting Kids with diabetes In Physical activity): Feasibility of a randomised controlled trial of a digital intervention for 9-12 year olds with type 1 diabetes mellitus.

Knox E, Glazebrook C, Randell T, Leighton P, Guo B, Greening J BMC Public Health. 2019; 19(1):371.

PMID: 30943939 PMC: 6446303. DOI: 10.1186/s12889-019-6697-1.

Psychometric evaluation of the Chinese version of the Child Health Utility 9D (CHU9D-CHN): a school-based study in China.

Yang P, Chen G, Wang P, Zhang K, Deng F, Yang H Qual Life Res. 2018; 27(7):1921-1931.

PMID: 29730851 DOI: 10.1007/s11136-018-1864-x.

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