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NCT Number: NCT05667753

Large Scale Implementation of MINISTOP 3.0

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.

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Key information

Conditions

Obesity, Child Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Huddinge, Stockholm County, 141 83, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child healthcare nurse at participating child healthcare centers

No exclusion criteria.

Treatment and study plan

MINISTOP 3.0

Behavioral

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.

Primary outcomes

  1. Change in acceptability of MINISTOP 3.0

    Time frame: Baseline, 3 &12 months after implementation

    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.

  2. Change in appropriateness of MINISTOP 3.0

    Time frame: Baseline, 3 & 12 months after implementation

    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.

  3. Change in feasibility of MINISTOP 3.0

    Time frame: Baseline, 3 &12 months after implementation

    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.

  4. Change in organizational readiness for implementing MINISTOP 3.0

    Time frame: Baseline 3 and 12 months after implementation

    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.

Secondary outcomes

  1. Adoption of MINISTOP 3.0

    Time frame: 3, 8, and 12 months after implementation

    Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score

  2. Costs of the implementation of MINISTOP 3.0

    Time frame: Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.

    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).

  3. Sustainability

    Time frame: 12 months after implementation

    Semi-structured interviews with primary child healthcare nurses

  4. Parental usage of MINISTOP 3.0 using objectively measured activity in the app

    Time frame: 6 months after the families start using the MINISTOP app

    Number of recordings and messages read in the app (per time unity such as per week)

  5. Children's intake of key dietary indicators as assess by a questionnaire.

    Time frame: Baseline and 6 months after receiving MINISTOP 3.0

    Intake of fruits, vegetables, sweet and savoury snacks, as well as sweetened beverages (grams/day)

  6. Children's physical activity as assessed by a questionnaire

    Time frame: Baseline and 6 months after receiving MINISTOP 3.0

    Time spent in moderate-to-vigorous physical activity (minutes/day)

  7. Children's screen time as assessed by a questionnaire

    Time frame: Baseline and 6 months after receiving MINISTOP 3.0

    Time spent watching screens (minutes/day)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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