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

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

Interventions

BEHAVIORAL

Food and Nutrition

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.

BEHAVIORAL

Physical Activity (FitFirst)

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.

BEHAVIORAL

Sleep and screen media

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.

BEHAVIORAL

Community capacity building

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.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Region Capital Denmark

  collaborator OTHER

• The Novo Nordisk Foundation

  collaborator UNKNOWN

• University of Copenhagen

  lead OTHER

Principal Investigators

• Nikolai B Nordsborg, PhD · University of Copenhagen

• Jens Troelsen, PhD · University of Southern Denmark

• Ulla Toft, PhD · Capitol Region of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-14

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• Denmark

Study Locations