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Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention (GHK)

Primary Purpose

Childhood Obesity, Well-Being, Psychological, Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Food and Nutrition
Physical Activity (FitFirst)
Sleep and screen media
Community capacity building
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Obesity, Well-being, Physical activity, Sleep, Screen time, Community intervention, Socioeconomic Disparities in Health, Diet

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 11 schools in the Capital Region of Denmark and Region ZealandRecruiting
  • 12 Schools in Region of Southern DenmarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Generation Healthy Kids intervention

Control

Arm Description

The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders.

The schools will continue with their regular school schedules.

Outcomes

Primary Outcome Measures

Fat mass in kg
Between group difference in change in fat mass measured by air-displacement plethysmography using a BOD POD.

Secondary Outcome Measures

Fat mass in kg (2)
Between group difference in change in fat mass measured by a bioimpedance analysis (InBody 270).
Fat free mass in kg
Between group difference in change in fat free mass measured by air-displacement plethysmography using a BOD POD.
Fat free mass in kg (2)
Between group difference in change in fat free mass measured by a bioimpedance analysis (InBody 270).
Fat mass index in kg/m2
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)
Between group difference in change in fat mass index measured by a bioimpedance analysis (InBody 270).
Fat free mass index in kg/m2
Between group difference in change in fat free mass index measured by air-displacement plethysmography using a BOD POD.
Fat free mass index in kg/m2 (2)
Between group difference in change in fat free mass index measured by a bioimpedance analysis (InBody 270).
Fat-Free-Mass-to-Fat-Mass ratio
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)
Between group difference in change in FFM-to-FM ratio measured by a bioimpedance analysis (InBody 270).
% Fat Mass
Between group difference in change in % FM in kg measured by air-displacement plethysmography using a BOD POD.
% Fat Mass (2)
Between group difference in change in % FM in kg measured by a bioimpedance analysis (InBody 270).
Height in cm
Between group difference in change in standing height measured using a portable stadiometer.
Weight status in %
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.
BMI z-score
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
Between group difference in change in waist circumference to the nearest mm by a non-elastic measuring tape at the level of the umbilicus.

Full Information

First Posted
July 4, 2023
Last Updated
October 9, 2023
Sponsor
University of Copenhagen
Collaborators
University of Southern Denmark, Region Capital Denmark, The Novo Nordisk Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05940675
Brief Title
Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention
Acronym
GHK
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Copenhagen
Collaborators
University of Southern Denmark, Region Capital Denmark, The Novo Nordisk Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1645 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Generation Healthy Kids intervention
Arm Type
Experimental
Arm Description
The intervention focuses on food and nutrition, physical activity, sleep and screen media habits, and engagement of the local stakeholders.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The schools will continue with their regular school schedules.
Intervention Type
Behavioral
Intervention Name(s)
Food and Nutrition
Intervention Description
A key element is that children receive a free of charge healthy do-it-yourself school lunch 4 days per week. The meals adhere to the Nordic Nutrition Recommendations and the Danish Food-Based Dietary Guidelines with focus on fish, wholegrains, fruits and vegetables and drinking water as well as stimulation of children's food literacy. Other intervention components involve the after school clubs, local retail stores and the parents.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity (FitFirst)
Intervention Description
To ensure that all children reach the recommended 3x30 minutes of vigorous activity per week, we will implement three weekly 40-minute sessions in the school curriculum. These sessions will be carried out throughout the study period and will encompass modified and varied sporting activities and games, which promote motivation, physical literacy, active involvement of all children, and high training intensity.
Intervention Type
Behavioral
Intervention Name(s)
Sleep and screen media
Intervention Description
The aim of this component is to promote healthy sleep and screen media behaviours. Sleep and screen media recommendations will be presented for parents at three parent workshops and in electronic infographics. Teachers/pedagogues will facilitate small assignments on screen media and sleep practices with children during school time. Children will talk about and reflect upon screen media and sleep practices in their family, based on assignments and material from e.g., Medierådet (The Danish Media Council). The results of the children's assignments will be presented to their parents at later workshops. This is done to integrate the children's perspective in the parent workshops, especially in relation to screen media habits.
Intervention Type
Behavioral
Intervention Name(s)
Community capacity building
Intervention Description
Community capacity building in selected local communities. To promote healthier eating, children and families need to be supported within their local community by food environments that make the healthy choice the easy choice and not a challenge in their everyday life. To promote physical activity, the children will be invited to participate in activities in the local sports clubs including camps in the holidays.
Primary Outcome Measure Information:
Title
Fat mass in kg
Description
Between group difference in change in fat mass measured by air-displacement plethysmography using a BOD POD.
Time Frame
Baseline and 18-20 months
Secondary Outcome Measure Information:
Title
Fat mass in kg (2)
Description
Between group difference in change in fat mass measured by a bioimpedance analysis (InBody 270).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Fat free mass in kg
Description
Between group difference in change in fat free mass measured by air-displacement plethysmography using a BOD POD.
Time Frame
Baseline and 18-20 months
Title
Fat free mass in kg (2)
Description
Between group difference in change in fat free mass measured by a bioimpedance analysis (InBody 270).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Fat mass index in kg/m2
Description
Between group difference in change in fat mass index measured by air-displacement plethysmography using a BOD POD.
Time Frame
Baseline and 18-20 months
Title
Fat mass index in kg/m2 (2)
Description
Between group difference in change in fat mass index measured by a bioimpedance analysis (InBody 270).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Fat free mass index in kg/m2
Description
Between group difference in change in fat free mass index measured by air-displacement plethysmography using a BOD POD.
Time Frame
Baseline and 18-20 months
Title
Fat free mass index in kg/m2 (2)
Description
Between group difference in change in fat free mass index measured by a bioimpedance analysis (InBody 270).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Fat-Free-Mass-to-Fat-Mass ratio
Description
Between group difference in change in FFM-to-FM ratio measured by air-displacement plethysmography using a BOD POD.
Time Frame
Baseline and 18-20 months
Title
Fat-Free-Mass-to-Fat-Mass ratio (2)
Description
Between group difference in change in FFM-to-FM ratio measured by a bioimpedance analysis (InBody 270).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
% Fat Mass
Description
Between group difference in change in % FM in kg measured by air-displacement plethysmography using a BOD POD.
Time Frame
Baseline and 18-20 months
Title
% Fat Mass (2)
Description
Between group difference in change in % FM in kg measured by a bioimpedance analysis (InBody 270).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Height in cm
Description
Between group difference in change in standing height measured using a portable stadiometer.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Weight status in %
Description
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.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
BMI z-score
Description
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.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Waist circumference in mm
Description
Between group difference in change in waist circumference to the nearest mm by a non-elastic measuring tape at the level of the umbilicus.
Time Frame
Baseline , 6-8 months, 18-20 months
Other Pre-specified Outcome Measures:
Title
Health related quality of life
Description
Between group difference in change in the total summary score of health-related quality of life measured with the KIDSCREEN 27 child self-report questionnaire. Data is collected using an adapted video and speech assisted electronic version with a smiley scale for each answer. The questionnaire assesses the child's physical well-being (5 items), psychological well-being (7 items), autonomy and parent relation (7 items), peers and social support (4 items), and school environment (4 items).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Mental health
Description
Between group difference in change in the total difficulties score of the Strengths and difficulties questionnaire. Assessed using the parent-reported version of the Strengths and Difficulties Questionnaire. An overall total difficulties score is calculated, along with five subscale scores: emotional symptoms, conduct problems, hyperactivity/Inattention, relationship problems, and prosocial behavior.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Resting blood pressure in mmHg
Description
Between group difference in change in systolic and diastolic blood pressure.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Resting heart rate beats/min
Description
Between group difference in change in heart rate.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Plasma lipid profile in mmol/L
Description
Between group difference in change in plasma total, LDL and HDL cholesterol and triacylglycerol. Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Plasma insulin in pmol/L.
Description
Between group difference in change in plasma insulin. Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Plasma glucose in mmol/L.
Description
Between group difference in change in plasma glucose. Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Aerobic fitness and intermittent exercise performance
Description
Between group difference in change in aerobic fitness and intermittent exercise performance.
Time Frame
Baseline, 6-8 months, 18-20 months
Title
Sprint performance
Description
Between group difference in change in sprint performance as measured by 20 m sprint test.
Time Frame
Baseline, 6-8 months, 18-20 months
Title
Muscular fitness and strength
Description
Between group difference in change in muscular fitness and strength.
Time Frame
Baseline, 6-8 months, 18-20 months
Title
Balance ability
Description
Between group difference in change in balance ability.
Time Frame
Baseline and 18-20 months
Title
Jump height
Description
Between group difference in change in jump height (countermovement jump).
Time Frame
Baseline and 18-20 months
Title
Upper and lower extremity gross motor function
Description
Between group difference in change in Upper and lower extremity gross motor function.
Time Frame
Baseline and 18-20 months
Title
Agility
Description
Between group difference in change in agility will be assessed using the Canadian Exercise and Movement Skills Assessment (CAMSA)
Time Frame
Baseline and 18-20 months
Title
Physically active behavior
Description
Between group change in total time spent being physical active. Non-sedentary time is defined as any waking activity characterized as not being in a sitting, reclining or lying posture with minimal stationary movement. Activity is measured for 7 consecutive days using a thigh worn accelerometer (Axivity AX3).
Time Frame
Baseline, 18-20 months
Title
Moderate to vigorous physical activity
Description
Between group change in time spent in moderate to vigorous physical activity. Moderate to vigorous physical activity is measured for 7 consecutive days using a thigh worn accelerometer (Axivity AX3).
Time Frame
Baseline, 18-20 months
Title
Total sleep time
Description
Between group change in total sleep time. Sleep is measured for 7 consecutive days using a thigh worn accelerometer (Axivity AX3).
Time Frame
Baseline, 18-20 months
Title
Sleep quality
Description
Between group difference in change in sleep quality, as measured by Child Sleep Habits Questionnaire (parent-reported).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Total screen time
Description
Between group difference in change in total screen time (hours), as measured by modified SCREENS questionnaire (parent-reported).
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Smartphone and tablet usage
Description
Between group difference in change in smartphone/tablet usage, objectively assessed over 14 days using Ethica application.
Time Frame
Baseline , 6-8 months, 18-20 months
Title
Food literacy
Description
Between group difference in change in child-reported using a GHK food literacy and meal culture questionnaire currently under development
Time Frame
Baseline, 6-8 months, 18-20 months
Title
School meal culture
Description
Between group difference in change in child-reported using a GHK food literacy and meal culture questionnaire currently under development
Time Frame
Baseline, 6-8 months, 18-20 months
Title
Family meal culture
Description
Between group difference in change in child-reported using a GHK food literacy and meal culture questionnaire currently under development
Time Frame
Baseline, 6-8 months, 18-20 months
Title
Dietary intake in g/day
Description
Between group difference in change in dietary intake by 3-day electronic dietary record and FFQ.
Time Frame
Baseline, 6-8 months, 18-20 months
Title
n-3 long-chain polyunsaturated fatty acid (LCPUFA) status in weight%
Description
Between group difference change in wholeblood n-3 LCPUFA status (eicosapentaenoic acid and docosahexaenoic acid). Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Blood hemoglobin in mmol/L.
Description
Between group difference in change in wholeblood hemoglobin (iron status). Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Serum ferritin in ug/L.
Description
Between group difference in change in serum ferritin (iron status). Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Serum 25-hydroxyvitamin D in nmol/L.
Description
Between group difference in change in serum 25-hydroxyvitamin D (vitamin D status). Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Insulin-like growth factor-1 in ug/L.
Description
Between group difference in change in serum insulin-like growth factor-1 (growth factor). Only among children in DK-EAST.
Time Frame
Baseline and 6-8 months, (18-20 months if funding is available)
Title
Processing speed
Description
Performance in neuropsychological assessment of processing speed as choice reaction time (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time Frame
Baseline and 18-20 months
Title
Sustained attention
Description
Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time Frame
Baseline and 18-20 months
Title
Spatial working memory
Description
Performance in neuropsychological assessment of spatial working memory assessed as errors and strategy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time Frame
Baseline and 18-20 months
Title
Inhibitory control
Description
Performance in neuropsychological assessment of inhibitory control assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time Frame
Baseline and 18-20 months
Title
Cognitive flexibility
Description
Performance in neuropsychological assessment of cognitive flexibility assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time Frame
Baseline and 18-20 months
Title
Fine motor control
Description
Performance in neuropsychological assessment of fine motor control assessed as endpoint accuracy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time Frame
Baseline and 18-20 months
Title
School performance - Danish reading comprehension
Description
Between group difference in change in Danish reading skills (Hogrefe, Denmark).
Time Frame
Baseline and 18-20 months
Title
School performance - mathematics proficiency
Description
Between group difference in change in mathematics proficiency (Hogrefe, Denmark).
Time Frame
Baseline and 18-20 months
Title
School absence due to sickness and other causes
Description
Between group difference in change in number of days abscent from school due to sickness recorded in school registration data
Time Frame
Baseline, 6-8 months, 18-20 months
Title
Physical literacy
Description
Between group difference in change in total score of physical literacy as well as for the emotional, cognitive and physical subdomain
Time Frame
Baseline, 18-20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Schmidt-Persson, PhD
Phone
+4565502054
Email
jespedersen@health.sdu.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Stevner, MSc
Phone
+4529266114
Email
less@nexs.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolai B Nordsborg, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jens Troelsen, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulla Toft, PhD
Organizational Affiliation
Capitol Region of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
11 schools in the Capital Region of Denmark and Region Zealand
City
Copenhagen
State/Province
Capital Region And Region Zealand
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolai Baastrup Nordsborg, PhD
Facility Name
12 Schools in Region of Southern Denmark
City
Odense
State/Province
Region Of Southern Denmark
ZIP/Postal Code
5230
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Troelsen, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Only de-indentified data will be shared.
IPD Sharing Access Criteria
A formal application must be approved by the study's steering committee.

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Generation Healthy Kids: A Cluster-randomized Trial of a Multi-component, Multi-setting Intervention

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