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

November 28, 2023 updated by: Liselotte Schäfer Elinder, Karolinska Institutet

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Basic
All schools will receive the HSS program. Schools randomly assigned to group 1 will receive implementation strategy bundle 1 (Basic).
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.
Experimental: Enhanced
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fidelity (A) assessed by questionnaire to parents and school staff
Time Frame: Measured at 12 and 24 months
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
Time Frame: Measured at 12 and 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in acceptability of the HSS program assessed by questionnaire
Time Frame: Measured at baseline, 12, 24, and 36 months
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
Change in appropriateness of the HSS program measured by questionnaire
Time Frame: Measured at baseline, 12, 24, and 36 months
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
Change in feasibility of the HSS program measured by questionnaire
Time Frame: Measured at baseline, 12, 24, and 36 months
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
Change in Organisational readiness of school principals assessed by questionnaire
Time Frame: Measured at baseline, 12, 24, and 36 months
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
Change in Organisational readiness by school staff assessed by questionnaire
Time Frame: Measured at baseline, 12, 24, and 36 months
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
Fidelity to implementation strategies assessed by checklist
Time Frame: May each year
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
Change in child weight status assessed through measurement of height (m) and weight (kg)
Time Frame: Measured at baseline and after 24 months
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
Change in child BMI z-score assessed through measurement of height (m) and weight (kg)
Time Frame: Measured at baseline and after 24 months
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
Change in child diet assessed by parent questionnaire
Time Frame: Baseline, 12 months, and 24 months
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
Change in parental feeding practices assessed by parent questionnaire
Time Frame: Baseline, 12 months, and 24 months
Assessed with the Swedish short version of the Comprehensive Feeding Practices Questionnire (CFPQ)
Baseline, 12 months, and 24 months
Change in parents' risk of type 2 diabetes assessed by FINDRISC questionnaire
Time Frame: Measured at Baseline, 12 months, and 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Liselotte S Elinder, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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