MINISTOP 3.0 / Obesity, Child · Interventional Study

Large Scale Implementation of MINISTOP 3.0

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered but not yet completed implementation trial comparing two deployment strategies (Basic vs. Enhanced) for MINISTOP 3.0, a behavioural app for obesity prevention in preschool children within Swedish primary healthcare. The study measures implementation science outcomes (acceptability, appropriateness, feasibility, organizational readiness) as primary endpoints, with secondary measurement of dietary indicators, physical activity, screen time, reach, costs, adoption, sustainability, and cost-effectiveness. No results are posted in this registry record.

What was studied

Interventional, Randomized, Parallel, Open label, Health Services Research purpose. Obesity, Child; age from 18 Years; accepts healthy volunteers. Intervention: Enhanced. Compared with: Basic — Active Comparator. n = 120. 1 site: Sweden.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This is a design and registration document only; clinical impact cannot be assessed until results are posted and peer-reviewed. The study aims to inform implementation of a digital behaviour-change tool in a healthcare system, which if successful could contribute evidence on deployment strategies rather than efficacy.

Plain-language summary

This is a clinical trial registry record describing an ongoing implementation study with no reported results; it documents planned design and outcomes only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in acceptability of MINISTOP 3.0 (assessed at Baseline, 3 &12 months after implementation); Change in appropriateness of MINISTOP 3.0 (assessed at Baseline, 3 & 12 months after implementation); Change in feasibility of MINISTOP 3.0 (assessed at Baseline, 3 &12 months after implementation); Change in organizational readiness for implementing MINISTOP 3.0 (assessed at Baseline 3 and 12 months after implementation)

DesignInterventional, Randomized, Parallel, Open label, Health Services Research purpose

PopulationObesity, Child; age from 18 Years; accepts healthy volunteers

Sample size120

InterventionEnhanced

ComparatorBasic — Active Comparator

Setting1 site: Sweden

Reported figures

Quoted from the source exactly as published.

Planned enrollment120

Primary outcome 1Change in acceptability of MINISTOP 3.0 (Baseline, 3 & 12 months)

Primary outcome 2Change in appropriateness of MINISTOP 3.0 (Baseline, 3 & 12 months)

Primary outcome 3Change in feasibility of MINISTOP 3.0 (Baseline, 3 & 12 months)

Primary outcome 4Change in organizational readiness for implementing MINISTOP 3.0 (Baseline, 3 & 12 months)

Clinical bottom line

Caveats

This registry record contains no results, outcome data, or effect sizes; study status is 'ACTIVE_NOT_RECRUITING', indicating enrolment complete but results not yet reported.
Primary outcomes are implementation science measures (acceptability, appropriateness, feasibility, organizational readiness), not clinical endpoints such as weight change or obesity prevalence.
No allocation concealment, blinding, or statistical analysis plan reported in this registry record.
Sample size justification and power calculation not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional comparison of two implementation strategies; design clearly specified in registry.

Directness

moderate

Primary outcomes are implementation science measures (acceptability, appropriateness, feasibility, organizational readiness), not clinical outcomes.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not describe allocation concealment, blinding, or other bias mitigation methods.

Sample adequacy

limited

Estimated 120 participants total; sample size justification not stated in registry record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05667753). This is a study registration, not published results. Lead sponsor: Karolinska Institutet. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Obesity, Child. Interventions: BEHAVIORAL: MINISTOP 3.0. Primary outcome measures: Change in acceptability of MINISTOP 3.0 , Baseline, 3 &12 months after implementation; Change in appropriateness of MINISTOP 3.0 , Baseline, 3 & 12 months after implementation; Change in feasibility of MINISTOP 3.0 , Baseline, 3 &12 months after implementation; Change in organizational readiness for implementing MINISTOP 3.0 , Baseline 3 and 12 months after implementation. Brief summary: MINISTOP is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. MINISTOP has been previously been evaluated in two previous trials (MINISTOP 1.0 and 2.0) with promising results. Therefore, the overall aim of this trial is to evaluate the large scale implementation of MINISTOP within Swedish primary child healthcare. The specific aims are to: (i) To compare two different implementation strategies for MINISTOP 3.0 (i.e., Basic vs. Enhanced) on: a) acceptability, appropriateness, feasibility as well as organizational readiness to implement MINISTOP 3.0 within primary child healthcare (primary outcomes) and b) reach, costs, adoption, and sustainability of MINISTOP 3.0 within primary child healthcare (secondary outcomes). (ii) To compare two different implementation strategies of MINISTOP 3.0 within primary child healthcare on children's key dietary indicators, physical activity, and screen time (secondary outcomes). (iii) To compare the cost-effectiveness of two different implementation strategies for MINISTOP 3.0.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

MINISTOP 3.0Karolinska InstitutetNCT05667753Obesity, Child