Large Scale Implementation of MINISTOP 3.0

NCT05667753 | Active Not Recruiting

• 1 other identifier: 2022-01710-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Child

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

Basic

ACTIVE COMPARATOR

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

Enhanced

EXPERIMENTAL

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

Interventions

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.

Basic; Enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Child healthcare nurse at participating child healthcare centers

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Huddinge, Stockholm County, 141 83, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39333981 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent

Model Details: Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 29, 2022
• Study Start: March 13, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)