NCT Number: NCT04984421
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.
Looking for future studies?
Notify Me5 year–70 year
All sexes
Interventional
Not applicable
Municipality, Huddinge, Stockholm County, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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)
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)
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.
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.
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).
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)
Time frame: Baseline, 12 months, and 24 months
Assessed with the Swedish short version of the Comprehensive Feeding Practices Questionnire (CFPQ)
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
Karolinska Institutet
Other
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
Acronym: IMPROVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03620773
Adolescent Obesity, Bariatric Surgery Candidate
Aurora, Colorado, United States
View Trial DetailsNCT05586269
Body Weight, Child Nutrition Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT02886208
Body Weight, Diabetes Mellitus
View Trial DetailsNCT03767608
Body Weight, Diabetes Mellitus
Monterrey, Nuevo León, Mexico
View Trial Details