MINISTOP 3.0: Implementation of a mHealth obesity prevention program within Swedish child healthcare – study protocol for a cluster randomized controlled trial.

Background: Previously, we have reported on the efficacy and real-world effectiveness of a parent-oriented mobile health intervention (MINISTOP 1.0 and 2.0), which have shown improvements in pre-school children's lifestyle behaviours. However, there is a need for implementation evidence. The overall aims of this study are to: (i) compare two different implementation strategies for MINISTOP 3.0 (Basic vs. Enhanced) on: acceptability, appropriateness, feasibility, organizational readiness to implement MINISTOP 3.0 within Swedish child healthcare (primary outcomes) as well as reach, costs, and adoption of MINISTOP 3.0 (secondary outcomes); (ii) evaluate cost-effectiveness of MINISTOP 3.0; (iii) explore the sustainability of MINISTOP 3.0; (iv) evaluate the determinants of effectiveness of MINISTOP 3.0 on children's key lifestyle behaviours; and (v) investigate the long-term effects of MINISTOP 3.0 on children's body mass index. Methods: A hybrid type III implementation-effectiveness design will be used. A cluster randomized controlled trial will be conducted to compare the effects of basic versus enhanced implementation strategies on the outcomes at the child healthcare level. A minimum of 50 child healthcare centers across Sweden will participate and we aim to recruit 120 nurses. Child healthcare nurses in both groups will offer the MINISTOP 3.0 app to the families at the 2.5/3-year routine visit. Basic implementation strategies include educational meeting with nurses, formal implementation blueprint, develop/distribute educational materials and enhanced implementation includes all aforementioned strategies plus auditing/providing feedback and ongoing training for nurses. All outcomes will be assessed at baseline and 12 months post-implementation. Implementation outcomes will be assessed quantitatively using questionnaires and sustainability will be assessed qualitatively at 12 months. Children's key lifestyle behaviours will be collected through a parental questionnaire within the MINISTOP app at baseline and 6 months after they have received the app. Children's weight/height will be measured at routine visits at 2.5/3 (baseline), 4 and 5 years of age. Discussion: This study will provide important implementation evidence with regards to implementing mHealth interventions within Swedish child healthcare at scale and these results have the potential to be generalized to other digital interventions being implemented in child healthcare. Trial registration: ClinicalTrials.gov, NCT05667753. Registered December 29, 2022. [ABSTRACT FROM AUTHOR]