Large Scale Implementation of MINISTOP 3.0

NCT ID: NCT05667753

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2026-07-31

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, 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.

Detailed Description

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Conditions

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Obesity, Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Basic

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.

Group Type ACTIVE_COMPARATOR

MINISTOP 3.0

Intervention Type 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.

Enhanced

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.

Group Type EXPERIMENTAL

MINISTOP 3.0

Intervention Type 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.

Interventions

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MINISTOP 3.0

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Child healthcare nurse at participating child healthcare centers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Christine Delisle Nyström

Docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska Institutet

Huddinge, Stockholm County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 39333981 (View on PubMed)

Other Identifiers

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2022-01710-01

Identifier Type: -

Identifier Source: org_study_id

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