Diabetes Mellitus, Type 2 Clinical Trial
— IMPROVEOfficial title:
IMplementation and Evaluation of the School-based Family Support PRogramme A Healthy School Start to Promote Child Health and Prevent OVErweight and Obesity (IMPROVE) - Study Protocol for a Cluster-randomized Trial
IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Thirty schools in two municipalities will receive the HSS program reaching about 1400 families per school year, for two years.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 70 Years |
Eligibility | Inclusion Criteria: - All children and their parents at the included schools. All involved personnel at the included schools Exclusion Criteria: - No |
Country | Name | City | State |
---|---|---|---|
Sweden | Municipality | Huddinge | Stockholm Region |
Sweden | Municipality | Sigtuna | Stockholm Region |
Sweden | Municipality | Södertälje | Stockholm Region |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in fidelity (A) assessed by questionnaire to parents and school staff | Adherence to the four HSS components by indicators developed for this study. Information will be gathered through attendance logs and questionnaires to school staff and parents. | Measured at 12 and 24 months | |
Primary | Change in fidelity (R) assessed by questionnaire to parents | Responsiveness to the four HSS components by indicators developed for this study. Information will be gathered through questionnaires to parents. | Measured at 12 and 24 months | |
Secondary | Change in acceptability of the HSS program assessed by questionnaire | Feasibility of implementing the intervention as perceived by school staff, measured with the questionnaire developed by Weiner et al. | Measured at baseline, 12, 24, and 36 months | |
Secondary | Change in appropriateness of the HSS program measured by questionnaire | Appropriateness of implementing the intervention as perceived by school staff, measured with the questionnaire developed by Weiner et al. | Measured at baseline, 12, 24, and 36 months | |
Secondary | Change in feasibility of the HSS program measured by questionnaire | Feasibility of implementing the intervention as perceived by school staff, measured with the questionnaire developed by Weiner et al. | Measured at baseline, 12, 24, and 36 months | |
Secondary | Change in Organisational readiness of school principals assessed by questionnaire | Organisational readiness to change as perceived by school principals with the Leader Readiness to Implement Tool (LRIT) | Measured at baseline, 12, 24, and 36 months | |
Secondary | Change in Organisational readiness by school staff assessed by questionnaire | Organisational readiness to change as perceived by school nurses and teachers with the Staff Readiness to Implement Tool (SRIT) | Measured at baseline, 12, 24, and 36 months | |
Secondary | Fidelity to implementation strategies assessed by checklist | Assessment based on checklist developed for this study. Each strategy will be graded as 0=not implemented, 1=partially implemented, 2=fully implemented. | May each year | |
Secondary | Change in child weight status assessed through measurement of height (m) and weight (kg) | Child BMI will be calculated as in kg/m^2. Weight status will be assessed using age-appropriate BMI cut-off values for thinness, overweight and obesity according to the International Obesity Task Force. | Measured at baseline and after 24 months | |
Secondary | Change in child BMI z-score assessed through measurement of height (m) and weight (kg) | Child BMI will be calculated as in kg/m^2. The BMI z-score will be calculated according to a Swedish reference standard (Karlberg). | Measured at baseline and after 24 months | |
Secondary | Change in child diet assessed by parent questionnaire | Dietary indicator foods (fruit, vegetables and energy-dense products) assessed by the diet portion of the Eating and Physical Activity Questionnaire (EPAQ) | Baseline, 12 months, and 24 months | |
Secondary | Change in parental feeding practices assessed by parent questionnaire | Assessed with the Swedish short version of the Comprehensive Feeding Practices Questionnire (CFPQ) | Baseline, 12 months, and 24 months | |
Secondary | Change in parents' risk of type 2 diabetes assessed by FINDRISC questionnaire | The FINDRISC self-evaluation test to calculate risk of developing type 2 diabetes on a scale from 0-26 points | Measured at Baseline, 12 months, and 24 months |
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