Clinical trial NCT05940675: Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
Official title: Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention to Promote Healthy Weight and Wellbeing in Danish School-aged Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Obesity
Well-Being, Psychological
Physical Inactivity
Sleep
Screen Time
Diet Habit
Keywords: Obesity
Well-being
Physical activity
Sleep
Screen time
Community intervention
Socioeconomic Disparities in Health
Diet
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region Capital Denmark
name: The Novo Nordisk Foundation
First posted: 2023-07-11
Enrollment: 1645
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* All children attending 1st or 2nd grade in the recruited schools

Exclusion Criteria:

- 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.

Primary outcomes:
measure: Fat mass in kg
timeFrame: Baseline and 18-20 months
Secondary outcomes:
measure: Fat mass in kg (2)
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Fat free mass in kg
timeFrame: Baseline and 18-20 months
measure: Fat free mass in kg (2)
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Fat mass index in kg/m2
timeFrame: Baseline and 18-20 months
measure: Fat mass index in kg/m2 (2)
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Fat free mass index in kg/m2
timeFrame: Baseline and 18-20 months
measure: Fat free mass index in kg/m2 (2)
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Fat-Free-Mass-to-Fat-Mass ratio
timeFrame: Baseline and 18-20 months
measure: Fat-Free-Mass-to-Fat-Mass ratio (2)
timeFrame: Baseline , 6-8 months, 18-20 months
measure: % Fat Mass
timeFrame: Baseline and 18-20 months
measure: % Fat Mass (2)
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Height in cm
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Weight status in %
timeFrame: Baseline , 6-8 months, 18-20 months
measure: BMI z-score
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Waist circumference in mm
timeFrame: Baseline , 6-8 months, 18-20 months
Other outcomes:
measure: Health related quality of life
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Mental health
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Resting blood pressure in mmHg
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Resting heart rate beats/min
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Plasma lipid profile in mmol/L
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Plasma insulin in pmol/L.
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Plasma glucose in mmol/L.
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Aerobic fitness and intermittent exercise performance
timeFrame: Baseline, 6-8 months, 18-20 months
measure: Sprint performance
timeFrame: Baseline, 6-8 months, 18-20 months
measure: Muscular fitness and strength
timeFrame: Baseline, 6-8 months, 18-20 months
measure: Balance ability
timeFrame: Baseline and 18-20 months
measure: Jump height
timeFrame: Baseline and 18-20 months
measure: Upper and lower extremity gross motor function
timeFrame: Baseline and 18-20 months
measure: Agility
timeFrame: Baseline and 18-20 months
measure: Physically active behavior
timeFrame: Baseline, 18-20 months
measure: Moderate to vigorous physical activity
timeFrame: Baseline, 18-20 months
measure: Total sleep time
timeFrame: Baseline, 18-20 months
measure: Sleep quality
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Total screen time
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Smartphone and tablet usage
timeFrame: Baseline , 6-8 months, 18-20 months
measure: Food literacy
timeFrame: Baseline, 6-8 months, 18-20 months
measure: School meal culture
timeFrame: Baseline, 6-8 months, 18-20 months
measure: Family meal culture
timeFrame: Baseline, 6-8 months, 18-20 months
measure: Dietary intake in g/day
timeFrame: Baseline, 6-8 months, 18-20 months
measure: n-3 long-chain polyunsaturated fatty acid (LCPUFA) status in weight%
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Blood hemoglobin in mmol/L.
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Serum ferritin in ug/L.
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Serum 25-hydroxyvitamin D in nmol/L.
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Insulin-like growth factor-1 in ug/L.
timeFrame: Baseline and 6-8 months, (18-20 months if funding is available)
measure: Processing speed
timeFrame: Baseline and 18-20 months
measure: Sustained attention
timeFrame: Baseline and 18-20 months
measure: Spatial working memory
timeFrame: Baseline and 18-20 months
measure: Inhibitory control
timeFrame: Baseline and 18-20 months
measure: Cognitive flexibility
timeFrame: Baseline and 18-20 months
measure: Fine motor control
timeFrame: Baseline and 18-20 months
measure: School performance - Danish reading comprehension
timeFrame: Baseline and 18-20 months
measure: School performance - mathematics proficiency
timeFrame: Baseline and 18-20 months
measure: School absence due to sickness and other causes
timeFrame: Baseline, 6-8 months, 18-20 months
measure: Physical literacy
timeFrame: Baseline, 18-20 months
Locations:
city: Copenhagen
country: Denmark
facility: 11 schools in the Capital Region of Denmark and Region Zealand
state: Capital Region And Region Zealand
city: Odense
country: Denmark
facility: 12 Schools in Region of Southern Denmark
state: Region Of Southern Denmark
Study officials:
affiliation: University of Copenhagen
name: Nikolai B Nordsborg, PhD
role: STUDY_DIRECTOR
affiliation: University of Southern Denmark
name: Jens Troelsen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capitol Region of Southern Denmark
name: Ulla Toft, PhD
role: STUDY_CHAIR
References: