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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Child
• Intervention / Treatment: Behavioral: MINISTOP 3.0

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm County
    • Huddinge, Stockholm County, Sweden, 141 83
      • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child healthcare nurse at participating child healthcare centers

No exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adoption of MINISTOP 3.0	Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score	3, 8, and 12 months after implementation

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 2022-01710-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No