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Large Scale Implementation of MINISTOP 3.0

Primary Purpose

Obesity, Child

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MINISTOP 3.0
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity, Child

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Child healthcare nurse at participating child healthcare centers No exclusion criteria.

Sites / Locations

  • Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Basic

Enhanced

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Adoption of MINISTOP 3.0
Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score
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).
Sustainability
Semi-structured interviews with primary child healthcare nurses
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)
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)
Children's physical activity as assessed by a questionnaire
Time spent in moderate-to-vigorous physical activity (minutes/day)
Children's screen time as assessed by a questionnaire
Time spent watching screens (minutes/day)

Full Information

First Posted
December 19, 2022
Last Updated
June 21, 2023
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05667753
Brief Title
Large Scale Implementation of MINISTOP 3.0
Official Title
Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Child

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcome assessors and participating families will be blinded, but child healthcare nurses will not be blinded.
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Basic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MINISTOP 3.0
Intervention Description
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 Outcome Measure Information:
Title
Change in acceptability of MINISTOP 3.0
Description
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.
Time Frame
Baseline and 3 months after implementation
Title
Change in appropriateness of MINISTOP 3.0
Description
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.
Time Frame
Baseline and 3 months after implementation
Title
Change in feasibility of MINISTOP 3.0
Description
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.
Time Frame
Baseline and 3 months after implementation
Title
Change in organizational readiness for implementing MINISTOP 3.0
Description
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.
Time Frame
Baseline and 3 and 12 months after implementation
Secondary Outcome Measure Information:
Title
Adoption of MINISTOP 3.0
Description
Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score
Time Frame
3 and 12 months after implementation
Title
Costs of the implementation of MINISTOP 3.0
Description
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).
Time Frame
Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.
Title
Sustainability
Description
Semi-structured interviews with primary child healthcare nurses
Time Frame
12 months after implementation
Title
Parental usage of MINISTOP 3.0 using objectively measured activity in the app
Description
Number of recordings and messages read in the app (per time unity such as per week)
Time Frame
6 months after the families start using the MINISTOP app
Title
Children's intake of key dietary indicators as assess by a questionnaire.
Description
Intake of fruits, vegetables, sweet and savoury snacks, as well as sweetened beverages (grams/day)
Time Frame
Baseline and 6 months after receiving MINISTOP 3.0
Title
Children's physical activity as assessed by a questionnaire
Description
Time spent in moderate-to-vigorous physical activity (minutes/day)
Time Frame
Baseline and 6 months after receiving MINISTOP 3.0
Title
Children's screen time as assessed by a questionnaire
Description
Time spent watching screens (minutes/day)
Time Frame
Baseline and 6 months after receiving MINISTOP 3.0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child healthcare nurse at participating child healthcare centers No exclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Delisle Nyström, PhD
Phone
+46764014500
Email
christine.delisle.nystrom@ki.se
Facility Information:
Facility Name
Karolinska Institutet
City
Huddinge
State/Province
Stockholm
ZIP/Postal Code
141 83
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Delisle Nyström, PhD
Phone
+46764014500
Email
christine.delisle.nystrom@ki.se

12. IPD Sharing Statement

Plan to Share IPD
No

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Large Scale Implementation of MINISTOP 3.0

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