Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
- Conditions
- Childhood ObesityWell-Being, PsychologicalPhysical InactivityDiet HabitSleepScreen Time
- Interventions
- Behavioral: Food and NutritionBehavioral: Physical Activity (FitFirst)Behavioral: Sleep and screen mediaBehavioral: Community capacity building
- Registration Number
- NCT05940675
- Lead Sponsor
- University of Copenhagen
- Brief Summary
The GHK intervention was developed according to the United Kingdom Medical Research Council's framework for developing and evaluating complex interventions. A pilot- and feasibility study was conducted during December 2022-April 2023, and the intervention was subsequently adapted and adjusted.
The GHK main trial is a two-school-year cluster-randomized school- and community trial designed to investigate the effect of the multi-setting, multi-component GHK intervention program on weight development, health and wellbeing in Danish children aged 6-11 years. The trial will include 24 schools in Denmark (12 intervention and 12 control).
The primary aim of the cluster-randomized trial is to investigate whether the GHK intervention program can promote healthy body composition as measured by fat mass (FM) in the intervention group compared with the control group. We hypothesize that the intervention will result in less FM gain in the intervention group compared with the control group over the two school-year study period.
- Detailed Description
Generation Healthy Kids is a cluster-randomized school and community trial in which 24 schools will be randomly allocated to intervention or control. Schools are evenly distributed in two areas of Denmark: DK-EAST (Capital Region of Denmark and Region Zealand) and DK-WEST (Region of Southern Denmark). The overall study objective is to investigate if a 2-school-year multi-setting, multi-component intervention focusing on healthy diets, physical activity, sleep and screen media habits in the school and local community can promote healthy weight and body composition in children who are in 1st and 2nd grade at inclusion (i.e., age 6-9 years at inclusion). We will also investigate the intervention's effects on dietary intake and nutritional status; food literacy; family- and school meal culture, physical literacy, activity levels, and fitness; sleep and screen media habits; growth; cardio metabolic health; cognitive and motor functions; school performance; and mental health and well-being. Furthermore, we will evaluate the context, implementation and working mechanisms of the intervention.
In continuation of the above, we will investigate if the intervention can reduce social inequality in the outcomes, as well as explore potential effect modifiers such as sex, ethnicity, implementation levels, genetics, epigenetics etc. We will also explore associations between sociodemographic characteristics, health behaviors and outcomes cross-sectionally and longitudinally and use these data to validate and compare relevant measurement tools.
The innovative aspects of the Generation Healthy Kids study are the combination of an intervention targeting several important risk factors for excessive weight gain (dietary habits, physical activity, sleep, and screen time) with community capacity building and a systems approach. The unique combination is closely monitored for effect as well as process. The integrated intervention program will be distinctive in combining already tested effective intervention strategies with intervention components developed using co-creation and a systems mapping and working in varying settings of the child's life. Systems thinking will furthermore be used to ensure that a health equity lens is employed to understand the relationship between obesity and health inequalities locally. To reach children and families with low socio-economic status, focus will be on developing interventions that make healthy choices easy by creating healthy environments around the children, both at school and during leisure time.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1645
- All children attending 1st or 2nd grade in the recruited schools
- No exclusion criteria will be applied. If parents, teachers or research staff judge that a child cannot participate in certain parts of the intervention or measurement schedule, e.g. due to severe allergies, chronic diseases or mental/physical disabilities, the child will be eligible to participate in the remaining parts of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Generation Healthy Kids intervention Physical Activity (FitFirst) The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders. Generation Healthy Kids intervention Sleep and screen media The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders. Generation Healthy Kids intervention Food and Nutrition The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders. Generation Healthy Kids intervention Community capacity building The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders.
- Primary Outcome Measures
Name Time Method Fat mass in kg Baseline and 18-20 months Between group difference in change in fat mass measured by air-displacement plethysmography using a BOD POD.
- Secondary Outcome Measures
Name Time Method Fat free mass index in kg/m2 Baseline and 18-20 months Between group difference in change in fat free mass index measured by air-displacement plethysmography using a BOD POD.
Fat mass in kg (2) Baseline , 6-8 months, 18-20 months Between group difference in change in fat mass measured by a bioimpedance analysis (InBody 270).
Fat free mass index in kg/m2 (2) Baseline , 6-8 months, 18-20 months Between group difference in change in fat free mass index measured by a bioimpedance analysis (InBody 270).
Weight status in % Baseline , 6-8 months, 18-20 months Between group difference in change in prevalence of children with underweight, normalweight, overweight and obesity, based on the cutoffs defined by Cole et al. and the International Task Force of Obesity. Body weight is measured by a bioimpedance analysis (InBody 270) and height by using a portable stadiometer.
% Fat Mass Baseline and 18-20 months Between group difference in change in % FM in kg measured by air-displacement plethysmography using a BOD POD.
Fat mass index in kg/m2 Baseline and 18-20 months Between group difference in change in fat mass index measured by air-displacement plethysmography using a BOD POD.
Fat mass index in kg/m2 (2) Baseline , 6-8 months, 18-20 months Between group difference in change in fat mass index measured by a bioimpedance analysis (InBody 270).
Fat free mass in kg Baseline and 18-20 months Between group difference in change in fat free mass measured by air-displacement plethysmography using a BOD POD.
Fat-Free-Mass-to-Fat-Mass ratio Baseline and 18-20 months Between group difference in change in FFM-to-FM ratio measured by air-displacement plethysmography using a BOD POD.
Fat-Free-Mass-to-Fat-Mass ratio (2) Baseline , 6-8 months, 18-20 months Between group difference in change in FFM-to-FM ratio measured by a bioimpedance analysis (InBody 270).
Height in cm Baseline , 6-8 months, 18-20 months Between group difference in change in standing height measured using a portable stadiometer.
% Fat Mass (2) Baseline , 6-8 months, 18-20 months Between group difference in change in % FM in kg measured by a bioimpedance analysis (InBody 270).
Fat free mass in kg (2) Baseline , 6-8 months, 18-20 months Between group difference in change in fat free mass measured by a bioimpedance analysis (InBody 270).
BMI z-score Baseline , 6-8 months, 18-20 months Between group difference in change in BMI z-score based on WHO references. Weight and height is measured using weight from the bioimpedance analysis (InBody 270) and a portable stadiometer, respectively.
Waist circumference in mm Baseline , 6-8 months, 18-20 months Between group difference in change in waist circumference to the nearest mm by a non-elastic measuring tape at the level of the umbilicus.
Trial Locations
- Locations (2)
12 Schools in Region of Southern Denmark
🇩🇰Odense, Region Of Southern Denmark, Denmark
11 schools in the Capital Region of Denmark and Region Zealand
🇩🇰Copenhagen, Capital Region And Region Zealand, Denmark