Clinical trial NCT04984421: IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Overnutrition, Child
Prediabetic State
Diabetes Mellitus, Type 2
Overweight, Childhood
Keywords: BMI
Fidelity
Hybrid type 3 design
Health promotion
Implementation strategies
Primary health care
School health care
Nutrition
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 1634
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial with a hybrid type 3 evaluation design
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All children and their parents at the included schools. All involved personnel at the included schools

Exclusion Criteria:

* No

Primary outcomes:
measure: Change in fidelity (A) assessed by questionnaire to parents and school staff
timeFrame: Measured at 12 and 24 months
measure: Change in fidelity (R) assessed by questionnaire to parents
timeFrame: Measured at 12 and 24 months
Secondary outcomes:
measure: Change in acceptability of the HSS program assessed by questionnaire
timeFrame: Measured at baseline, 12, 24, and 36 months
measure: Change in appropriateness of the HSS program measured by questionnaire
timeFrame: Measured at baseline, 12, 24, and 36 months
measure: Change in feasibility of the HSS program measured by questionnaire
timeFrame: Measured at baseline, 12, 24, and 36 months
measure: Change in Organisational readiness of school principals assessed by questionnaire
timeFrame: Measured at baseline, 12, 24, and 36 months
measure: Change in Organisational readiness by school staff assessed by questionnaire
timeFrame: Measured at baseline, 12, 24, and 36 months
measure: Fidelity to implementation strategies assessed by checklist
timeFrame: May each year
measure: Change in child weight status assessed through measurement of height (m) and weight (kg)
timeFrame: Measured at baseline and after 24 months
measure: Change in child BMI z-score assessed through measurement of height (m) and weight (kg)
timeFrame: Measured at baseline and after 24 months
measure: Change in child diet assessed by parent questionnaire
timeFrame: Baseline, 12 months, and 24 months
measure: Change in parental feeding practices assessed by parent questionnaire
timeFrame: Baseline, 12 months, and 24 months
measure: Change in parents' risk of type 2 diabetes assessed by FINDRISC questionnaire
timeFrame: Measured at Baseline, 12 months, and 24 months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Municipality
state: Stockholm Region
city: Sigtuna
country: Sweden
facility: Municipality
state: Stockholm Region
city: Södertälje
country: Sweden
facility: Municipality
state: Stockholm Region
Study officials:
affiliation: Karolinska Institutet
name: Liselotte S Elinder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elinder LS, Wiklund CA, Norman A, Stattin NS, Andermo S, Patterson E, Hemmingsson E, Cook C, Raposo S, Kwak L. IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial. BMC Public Health. 2021 Sep 6;21(1):1630. doi: 10.1186/s12889-021-11663-2.