Large Scale Implementation of MINISTOP 3.0

Study Overview
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Brief Summary
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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, fidelity, 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.

Official Title
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Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol

Conditions
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Obesity, Child

Intervention / Treatment
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* Behavioral: MINISTOP 3.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child healthcare nurse at participating child healthcare centers No exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Basic<br>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. | Behavioral: MINISTOP 3.0<br>* 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.<br>|
| Experimental: Enhanced<br>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. | Behavioral: MINISTOP 3.0<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and 3 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 and 3 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 and 3 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 and 3 and 12 months after implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adoption of MINISTOP 3.0 | Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score | 3 and 12 months after implementation | 
| Costs of the implementation of MINISTOP 3.0 | Collected through administrative data from participating child healthcare centers regarding implementing and maintaining the MINISTOP platform, as well as the nurses time with the MINISTOP program (Swedish Krona, SEK). | Baseline and 2, 4, 6, 8, 10, and 12 months after implementation. | 
| Sustainability | Semi-structured interviews with primary child healthcare nurses | 12 months after implementation | 
| Parental usage of MINISTOP 3.0 using objectively measured activity in the app | Number of recordings and messages read in the app (per time unity such as per week) | 6 months after the families start using the MINISTOP app | 
| Children's intake of key dietary indicators as assess by a questionnaire. | Intake of fruits, vegetables, sweet and savoury snacks, as well as sweetened beverages (grams/day) | Baseline and 6 months after receiving MINISTOP 3.0 | 
| Children's physical activity as assessed by a questionnaire | Time spent in moderate-to-vigorous physical activity (minutes/day) | Baseline and 6 months after receiving MINISTOP 3.0 | 
| Children's screen time as assessed by a questionnaire | Time spent watching screens (minutes/day) | Baseline and 6 months after receiving MINISTOP 3.0 |