JMIR Publications

ABSTRACT

Background:

Process evaluation of translation trials is critical in providing a comprehensive implementation assessment alongside effectiveness testing; however, few studies have provided detailed reporting of process evaluation results.

Objective:

This study reports findings from a mixed-methods process evaluation of a large translational trial comparing two remotely delivered healthy eating and active living interventions to an active control, targeting parents of young children. The study reports process outcomes including recruitment strategies, participant representativeness, intervention preference, fidelity, and acceptability, and study withdrawal.

Methods:

Mixed-methods process evaluation data were collected as a part of a three-arm partially randomised preference trial targeting parents of 2- to 6-year-old children from New South Wales, Australia. Recruitment strategies were assessed through the participant baseline questionnaire and a questionnaire completed by health promotion staff who were involved in recruitment. Data on participant intervention preference were collected at baseline and post-intervention. Intervention acceptability and demographic data were collected via a process evaluation questionnaire at post-intervention (approximately 3 months post-baseline), which was supplemented by qualitative participant interviews. Implementation data on intervention fidelity and withdrawal was also recorded. Differences in intervention acceptability, fidelity, and withdrawal rates between the telephone and online interventions, and between randomised and non-randomised participants were analysed. The significance level was set at P <.05 for all tests. Interview content was analysed and key themes were drawn from participant responses and findings were described narratively.

Results:

Data were collected from 458 participants at the baseline survey, 144 participants at the 3-month post-intervention survey, and 30 participants completed qualitative interviews. Six health promotion staff participated in the survey regarding recruitment strategies. Most participants were recruited from Early Childhood Education and Care services. There was broad reach of the study but better take-up rates in regional and rural areas compared to metropolitan areas. Parents with a university education were over-represented in the study. Most participants preferred the online medium of delivery at baseline. There was high acceptability of the online and telephone interventions. Participants found the healthy eating content to be the most useful component of the modules (online) and calls (telephone). They regarded the text (online) or verbal (telephone) information as the most useful component. A high proportion of participants completed the telephone intervention compared to the online intervention; however, more telephone participants actively withdrew from the telephone intervention.

Conclusions:

This is one of the first studies to comprehensively report on process evaluation data from a translation trial, which demonstrated high acceptability of all interventions but strong participant preference for the online intervention. This detailed process evaluation is critical to inform further implementation and to be considered alongside effectiveness outcomes.