IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE)

Diabetes Mellitus, Type 2 Clinical Trial

— IMPROVE  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984421
• Other study ID #: 2020-01198
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: Kristi S Annerstedt, PhD
• Phone: (0)70-9202081
• Email: kristi.sidney[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effects of bundled implementation strategies on the intervention fidelity (primary outcome) of the Healthy School Start (HSS) program while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parent risk of developing type 2 diabetes. IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months. Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1+2 (Enhanced), consisting mainly of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include acceptability, appropriateness, feasibility, organisational readiness as perceived by school staff, child weight status and diet, and parents' risk of type 2 diabetes. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and stakeholder perceptions on sustainability. This systematic approach to investigating the effects of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and the external supports needed for a school-based health program like the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Diabetes Mellitus, Type 2
• Obesity
• Overnutrition
• Overweight
• Overweight, Childhood
• Pediatric Obesity
• Prediabetic State

Intervention

Behavioral:
• Healthy School Start
The Healthy School Start program is a universal 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents' risk of developing type 2 diabetes. It is targeting both children and parents.

Locations

Country	Name	City	State
Sweden	Municipality	Huddinge	Stockholm Region
Sweden	Municipality	Sigtuna	Stockholm Region
Sweden	Municipality	Södertälje	Stockholm Region

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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

External Links

•   Project website