Large Scale Implementation of MINISTOP 3.0

Obesity, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667753
• Other study ID #: 2022-01710-01
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: January 2024
• Source: Karolinska Institutet
• Contact: Christine Delisle Nyström, PhD
• Phone: +46764014500
• Email: christine.delisle.nystrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Child healthcare nurse at participating child healthcare centers

No exclusion criteria.

Related Conditions & MeSH terms

• Obesity
• Obesity, Child
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	Sustainability	Semi-structured interviews with primary child healthcare nurses	12 months after implementation
Secondary	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
Secondary	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
Secondary	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
Secondary	Children's screen time as assessed by a questionnaire	Time spent watching screens (minutes/day)	Baseline and 6 months after receiving MINISTOP 3.0