NCT05667753|Active Not Recruiting
Large Scale Implementation of MINISTOP 3.0
Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
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Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
Sponsor study identifier
interventional
120
1 country
1
Study Start
March 13, 2023
Actual (reported)Primary Completion
March 5, 2026
Actual (reported)Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2022
Actual (reported)December 29, 2022
Actual (reported)March 13, 2023
Actual (reported)March 5, 2026
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in acceptability of MINISTOP 3.0
Acceptability of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Baseline, 3 &12 months after implementation
Change in appropriateness of MINISTOP 3.0
Appropriateness of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Baseline, 3 & 12 months after implementation
Change in feasibility of MINISTOP 3.0
Feasibility of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Baseline, 3 &12 months after implementation
Change in organizational readiness for implementing MINISTOP 3.0
Organizational readiness as perceived by child healthcare nurses, which will be measured using the E-READY questionnaire. This questionnaire consists of 32 questions rated on a 4-point likert scale.
Baseline 3 and 12 months after implementation
Adoption of MINISTOP 3.0
3, 8, and 12 months after implementation
Costs of the implementation of MINISTOP 3.0
Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.
Sustainability
12 months after implementation
Parental usage of MINISTOP 3.0 using objectively measured activity in the app
6 months after the families start using the MINISTOP app
Children's intake of key dietary indicators as assess by a questionnaire.
Baseline and 6 months after receiving MINISTOP 3.0
The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the basic group will receive the basic implementation strategy package.
The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the enhanced group will receive the enhanced implementation strategy package.
MINISTOP 3.0 is a behavioral changed program with the overall aim to promote healthier lifestyle behaviors (i.e., diet, physical activity, and sedentary behavior) among 2.5/3-year old children. The MINISTOP 3.0 program consists of features such as information, monitoring, and feedback (dietary variables, physical activity, and screen time) and is built around 13 themes over a 6-month period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Karolinska Institutet
Huddinge, Stockholm County, 141 83, Sweden
Thomas K, Lof M, Lundgren M, Fagerstrom M, Hesketh KD, Brown V, Habel H, Delisle Nystrom C. MINISTOP 3.0: Implementation of a mHealth obesity prevention program within Swedish child healthcare - study protocol for a cluster randomized controlled trial. BMC Public Health. 2024 Sep 27;24(1):2594. doi: 10.1186/s12889-024-20137-0.
First Submitted
December 19, 2022
First Posted
December 29, 2022
Study Start
March 13, 2023
Actual (reported)Primary Completion
An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment
March 5, 2026
Actual (reported)Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 12, 2026
Record last verified: 2026-08
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