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

NCT ID: NCT04984421

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1634 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-09-30

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.

Conditions

Pediatric Obesity; Overnutrition, Child; Prediabetic State; Diabetes Mellitus, Type 2; Overweight, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Basic

All schools will receive the HSS program. Schools randomly assigned to group 1 will receive implementation strategy bundle 1 (Basic).

Group Type: ACTIVE_COMPARATOR

Healthy School Start

Intervention Type: BEHAVIORAL

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.

Enhanced

All schools will receive the HSS program. Schools randomly assigned to group 2 will receive implementation strategy bundle 1+2 (Enhanced).

Group Type: EXPERIMENTAL

Healthy School Start

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Liselotte Schäfer Elinder

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liselotte S Elinder, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Municipality

Huddinge, Stockholm County, Sweden

Municipality

Sigtuna, Stockholm County, Sweden

Municipality

Södertälje, Stockholm County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34488691 (View on PubMed)

Related Links

https://ki.se/gph/en-frisk-skolstart

Project website

Other Identifiers

2020-01198

Identifier Type: -

Identifier Source: org_study_id