Clinical trial NCT05667753: 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
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Child
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Child healthcare nurse at participating child healthcare centers

No exclusion criteria.

Primary outcomes:
measure: Change in acceptability of MINISTOP 3.0
timeFrame: Baseline, 3 &12 months after implementation
measure: Change in appropriateness of MINISTOP 3.0
timeFrame: Baseline, 3 & 12 months after implementation
measure: Change in feasibility of MINISTOP 3.0
timeFrame: Baseline, 3 &12 months after implementation
measure: Change in organizational readiness for implementing MINISTOP 3.0
timeFrame: Baseline 3 and 12 months after implementation
Secondary outcomes:
measure: Adoption of MINISTOP 3.0
timeFrame: 3, 8, and 12 months after implementation
measure: Costs of the implementation of MINISTOP 3.0
timeFrame: Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.
measure: Sustainability
timeFrame: 12 months after implementation
measure: Parental usage of MINISTOP 3.0 using objectively measured activity in the app
timeFrame: 6 months after the families start using the MINISTOP app
measure: Children's intake of key dietary indicators as assess by a questionnaire.
timeFrame: Baseline and 6 months after receiving MINISTOP 3.0
measure: Children's physical activity as assessed by a questionnaire
timeFrame: Baseline and 6 months after receiving MINISTOP 3.0
measure: Children's screen time as assessed by a questionnaire
timeFrame: Baseline and 6 months after receiving MINISTOP 3.0
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet
state: Stockholm
Study officials:
References: