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

NCT04984421 | Completed

• 1 other identifier: 2020-01198
• Study Type: interventional
• Target: 1,634
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• Change in acceptability of the HSS program assessed by questionnaire

  Measured at baseline, 12, 24, and 36 months

• Change in appropriateness of the HSS program measured by questionnaire

  Measured at baseline, 12, 24, and 36 months

• Change in feasibility of the HSS program measured by questionnaire

  Measured at baseline, 12, 24, and 36 months

• Change in Organisational readiness of school principals assessed by questionnaire

  Measured at baseline, 12, 24, and 36 months

• Change in Organisational readiness by school staff assessed by questionnaire

  Measured at baseline, 12, 24, and 36 months

Study Arms (2)

Basic

ACTIVE COMPARATOR

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

Behavioral: Healthy School Start

Enhanced

EXPERIMENTAL

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

Behavioral: Healthy School Start

Interventions

Healthy School Start 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.

Basic; Enhanced

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (3)

Municipality

Huddinge, Stockholm County, Sweden

Location

Municipality

Sigtuna, Stockholm County, Sweden

Location

Municipality

Södertälje, Stockholm County, Sweden

Location

Related Publications (2)

• Annerstedt KS, Ahlgren JA, Patterson E, Andermo S, Norman A, Raposo S, Kwak L, Elinder LS. Comparing tailored implementation strategies to improve intervention fidelity in a school-based obesity prevention program: the IMPROVE hybrid type III trial. Implement Sci. 2025 Dec 28. doi: 10.1186/s13012-025-01481-0. Online ahead of print.

  PMID: 41455974 DERIVED

• 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.

  PMID: 34488691 DERIVED

Related Links

• Project website

MeSH Terms

Conditions

Pediatric Obesity; Child Nutrition Disorders; Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Liselotte S Elinder, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Researchers and school personnel will not be blinded to group allocation, but parents and children will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Cluster randomized controlled trial with a hybrid type 3 evaluation design

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 30, 2021
• Study Start: September 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)