JMIR Publications

ABSTRACT

Background:

Behaviour change interventions, including diet and physical activity, can significantly improve clinical psychosocial outcomes for children in treatment for obesity. Interventions to address rate of eating, satiety and appetite perceptions have shown promise in eHealth clinical studies.

Objective:

To describe process methods for applying a mobile health (mHealth) intervention to reduce rate of eating and monitor physical activity among children in treatment for obesity in a tertiary outpatient setting.

Methods:

The study protocol was designed to incorporate two mHealth apps as an adjunct to usual care treatment for obesity. Children and adolescents (9-16 years) with obesity (BMI ≥98th centile) were recruited in person from the weight management service at a tertiary healthcare centre in the Republic of Ireland. Eligible participants and their parent(s) received information leaflets and informed consent and assent were signed. Participants completed two weeks of baseline testing including behavioural and quality of life questionnaires, anthropometry, rate of eating by Mandolean® and physical activity level using a smart-watch and myBigO smartphone application (app) with support from a dietetic researcher. Thereafter, participants were randomised to: (1) Intervention: Usual clinical care + Mandolean® training to reduce rate of eating or (2) Control: Usual clinical care. Gender and age group (9.0-12.9 years and 13.0-16.9 years) stratifications were applied. At the end of a 4-week treatment period, participants repeated the 2-week testing period. Process evaluation measures were documented including recruitment, study retention, fidelity parameters, acceptability and user satisfaction with mHealth tools.

Results:

Twenty participants were enrolled in the study. An online randomisation system assigned 8 participants to intervention and 12 to control. Attrition was higher among the intervention group (5 of 8 participants; 63%) compared to the control group (3 of 12 participants; 25%). Exposure to planned treatment dose was not met. Intervention participants undertook a median of 1.0 training meal using Mandolean® (25th, 75th Centiles 0, 9.3), which represented 19.2% of planned intervention exposure. Eighteen participants were successfully registered with smartwatches and myBigO, however only 9 of 18 participants (50%) logged physical activity data. Significant differences in psychosocial profile were observed at baseline between the groups (Child Behaviour Checklist (CBCL) Total T-score 71.7±3.1 vs. 57.6±6.6, p<.0001)and in those who completed the planned protocol compared to those who withdrew early (CBCL Total T-score 59.0±9.3 vs 67.9±5.6, p=0.044.)

Conclusions:

A high early attrition rate was a key barrier to full study implementation. Low exposure to the experimental intervention was explained by poor acceptability of Mandolean as a home-based tool for treatment. Self-monitoring using myBigO and smartwatch was acceptable among this cohort. Further technical and usability studies, are needed to improve adherence in our patient group in the tertiary setting. High perceived task burden in combination with behavioural issues may have contributed to attrition. mHealth interventions are rapidly progressing, however, we need to be cautious in terms of efficacy, burden to participants and our responsibility to identify vulnerable sub-groups at baseline. Clinical Trial: This was a feasibility study with a randomised design to ascertain the feasibility of a proposed protocol and we did not register as a trial.