Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in acceptability of MINISTOP 3.0
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Child healthcare nurse at participating child healthcare centers
- •No exclusion criteria.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in acceptability of MINISTOP 3.0
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Adoption of MINISTOP 3.0(3, 8, and 12 months after implementation)
- Costs of the implementation of MINISTOP 3.0(Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.)
- Sustainability(12 months after implementation)
- Parental usage of MINISTOP 3.0 using objectively measured activity in the app(6 months after the families start using the MINISTOP app)
- Children's intake of key dietary indicators as assess by a questionnaire.(Baseline and 6 months after receiving MINISTOP 3.0)
- Children's physical activity as assessed by a questionnaire(Baseline and 6 months after receiving MINISTOP 3.0)
- Children's screen time as assessed by a questionnaire(Baseline and 6 months after receiving MINISTOP 3.0)
Investigators
Christine Delisle Nyström
Docent
Karolinska Institutet