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

NCT05940675 | Completed

• 1 other identifier: S-20220094
• Study Type: interventional
• Target: 1,372
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Fat mass in kg

  Between group difference in change in fat mass measured by bioimpedance analysis (InBody 270).

  Baseline and 18-20 months

Secondary Outcomes (10)

• Fat mass in kg (2)

  Baseline , 6-8 months, 18-20 months

• Fat free mass in kg

  Baseline , 6-8 months, 18-20 months

• Fat mass index in kg/m2

  Baseline , 6-8 months, 18-20 months

• Fat free mass index in kg/m2

  Baseline , 6-8 months, 18-20 months

• Fat-Free-Mass-to-Fat-Mass ratio

  Baseline , 6-8 months, 18-20 months

Other Outcomes (39)

• Health related quality of life

  Baseline , 6-8 months, 18-20 months

• Mental health

  Baseline , 6-8 months, 18-20 months

• Resting blood pressure in mmHg

  Baseline , 6-8 months, 18-20 months

Study Arms (2)

Generation Healthy Kids intervention

EXPERIMENTAL

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

Behavioral: Food and Nutrition; Behavioral: Physical Activity (FitFirst); Behavioral: Sleep and screen media; Behavioral: Community capacity building

Control

NO INTERVENTION

The schools will continue with their regular school schedules.

Interventions

Food and Nutrition BEHAVIORAL

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.

Generation Healthy Kids intervention

Physical Activity (FitFirst) BEHAVIORAL

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.

Generation Healthy Kids intervention

Sleep and screen media BEHAVIORAL

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.

Generation Healthy Kids intervention

Community capacity building BEHAVIORAL

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.

Generation Healthy Kids intervention

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Southern Denmark: collaborator
• Region Capital Denmark: collaborator
• The Novo Nordisk Foundation: collaborator

Study Sites (2)

11 schools in the Capital Region of Denmark and Region Zealand

Copenhagen, Capital Region and Region Zealand, Denmark

Location

12 Schools in Region of Southern Denmark

Odense, Region Syddanmark, 5230, Denmark

Location

Related Publications (1)

• Thomsen LT, Schmidt-Persson J, Damsgaard CT, Krustrup P, Grontved A, Krolner RF, Nielsen G, Lundbye-Jensen J, Skovgaard T, Molgaard C, Hansen ABG, Hoeeg D, Larsen MN, Lund L, Melby PS, Pedersen NH, Troelsen J, Nordsborg NB, Toft U. Generation Healthy Kids: Protocol for a cluster-randomized controlled trial of a multi-component and multi-setting intervention to promote healthy weight and wellbeing in 6-11-year-old children in Denmark. PLoS One. 2024 Dec 5;19(12):e0308142. doi: 10.1371/journal.pone.0308142. eCollection 2024.

  PMID: 39636875 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Psychological Well-Being; Sedentary Behavior; Feeding Behavior; Obesity; Motor Activity

Interventions

Food; Nutritional Status; Exercise; Sleep

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena; Health Status; Demography; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena

Study Officials

• Nikolai B Nordsborg, PhD

  University of Copenhagen

  STUDY DIRECTOR

• Jens Troelsen, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

• Ulla Toft, PhD

  Capitol Region of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: August 14, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: A formal application must be approved by the study's steering committee.

Locations

DK (2)