Obesity, Child
Conditions
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.
Interventions
BEHAVIORALMINISTOP 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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Cluster randomized controlled trial utilizing a hybrid type III implementation-effectiveness design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Child healthcare nurse at participating child healthcare centers No
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in acceptability of MINISTOP 3.0 | Baseline, 3 &12 months after implementation | 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 | Baseline, 3 & 12 months after implementation | 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 | Baseline, 3 &12 months after implementation | 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 | Baseline 3 and 12 months after implementation | 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
| Measure | Time frame | Description |
|---|---|---|
| Adoption of MINISTOP 3.0 | 3, 8, and 12 months after implementation | Assessment based on a questionnaire from 1 to 5 with 5 indicating a better score |
| Costs of the implementation of MINISTOP 3.0 | Baseline and 2, 4, 6, 8, 10, and 12 months after implementation. | 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 | 12 months after implementation | Semi-structured interviews with primary child healthcare nurses |
| Parental usage of MINISTOP 3.0 using objectively measured activity in the app | 6 months after the families start using the MINISTOP 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. | Baseline and 6 months after receiving MINISTOP 3.0 | Intake of fruits, vegetables, sweet and savoury snacks, as well as sweetened beverages (grams/day) |
| Children's physical activity as assessed by a questionnaire | Baseline and 6 months after receiving MINISTOP 3.0 | Time spent in moderate-to-vigorous physical activity (minutes/day) |
| Children's screen time as assessed by a questionnaire | Baseline and 6 months after receiving MINISTOP 3.0 | Time spent watching screens (minutes/day) |
Countries
Sweden
Outcome results
None listed