NCT03647007

Brief Summary

The purpose of the study is: (1) to evaluate the short-term effects of a 10-week residential stay in a Danish Christmas Seal Home on health, physical fitness, physical activity level, learning, sleep and well-being; (2) to investigate the long-term effects 3 and 12 months after the stay; and (3) to examine whether a special effort involving a high-intensity activity/health education programme (FIFA 11 for Health) increases the effects on physical fitness and health knowledge, learning capabilities, sleep patterns, well-being and adherence to a physically active lifestyle compared to the standard programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

6.3 years

First QC Date

August 20, 2018

Last Update Submit

June 3, 2026

Conditions

Overweight

Keywords

fat percentagephysical fitnesswell-beingsmall-sided games

Outcome Measures

Primary Outcomes (1)

  • changes in overweight

    measurements of fat percentage, portable body composition analyser (InBody 720)

    baseline, 10 weeks, follow-up - 3 and 12 months

Secondary Outcomes (4)

  • aerobic fitness, measured with Andersen running test

    baseline, 10 weeks, follow-up - 3 and 12 months

  • health knowledge, questionnaires

    baseline, 10 weeks, follow-up - 3 and 12 months

  • well-being, questionnaires

    baseline, 10 weeks, follow-up - 3 and 12 months

  • BMI z-scores

    baseline, 10 weeks, follow-up - 3 and 12 months

Other Outcomes (5)

  • muscle mass, portable body composition analyser (InBody 720)

    baseline, 10 weeks, follow-up - 3 and 12 months

  • sleep patterns, questionnaires

    baseline, 10 weeks, follow-up - 12 months

  • daily activity patterns, accelerometre

    baseline, 10 weeks, follow-up - 12 months

  • +2 more other outcomes

Study Arms (2)

Standard group

NO INTERVENTION

The Standard programme on the Christmas Seal Homes.

FIFA Group

EXPERIMENTAL

The Standard programme including FIFA 11 for Health programme - health knowledge on the football pitch.

Other: FIFA 11 for health

Interventions

FIFA 11 for healthOTHER

The training consists of various football exercises, such as passing, shooting, dribbling, etc., and small-sided games. The small-sided games are performed as e.g. 3v3 with small goals (2x5 m).

FIFA Group

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Boys and girls aged 7-14 years undergoing a 10-week DCSH residential stay.
  • Informed consent from parents/legal guardian.
  • Willingness to participate in training and testing.

You may not qualify if:

  • Participants found by the researchers to be unsuited to following the procedures of the protocol and the training and testing programme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skælskør Julemærkehjem

Skælskør, Region Sjælland, 4230, Denmark

Location

Kildemose Julemærkehjem

Ølsted, Region Sjælland, 3310, Denmark

Location

Related Publications (2)

  • Pfeffer K, Nejst Larsen M, Cimenti C, Krustrup P, Ntoumanis N. Using the behaviour change intervention ontology to examine the inclusion, delivery and experience of behaviour change techniques in a youth health promotion programme. J Health Psychol. 2026 Jan 30:13591053251408386. doi: 10.1177/13591053251408386. Online ahead of print.

    PMID: 41615742DERIVED

  • Pfeffer K, Larsen MN, Heidler J, Moller TK, Tarantino G, Ntoumanis N, Krustrup P. The Long-Term Effects of a Combined Physical Activity and Health Education Programme on Well-Being for Socially Vulnerable Children and Adolescents. Scand J Med Sci Sports. 2025 Nov;35(11):e70171. doi: 10.1111/sms.70171.

    PMID: 41263246DERIVED

MeSH Terms

Conditions

Overweight

Interventions

Health

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Peter Krustrup

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 27, 2018

Study Start

September 11, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations

DK(2)