Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short- and Long-term Health Effects of a Residential Stay in a Danish Christmas Seal Home.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03647007
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Peter Krustrup, University of Southern Denmark

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.

Condition or disease Intervention/treatment Phase
Overweight Other: FIFA 11 for health Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evidence of the Short- and Long-term Effects of a Residential Stay in a Danish Christmas Seal Home - With and Without a High-intensity Activity/Health Education (FIFA 11 for Health) Programme.
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
No Intervention: Standard group
The Standard programme on the Christmas Seal Homes.
Experimental: FIFA Group
The Standard programme including FIFA 11 for Health programme - health knowledge on the football pitch.
Other: FIFA 11 for health
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).




Primary Outcome Measures :
  1. changes in overweight [ Time Frame: baseline, 10 weeks, follow-up - 3 and 12 months ]
    measurements of fat percentage, portable body composition analyser (InBody 720)


Secondary Outcome Measures :
  1. aerobic fitness, measured with Andersen running test [ Time Frame: baseline, 10 weeks, follow-up - 3 and 12 months ]
    The original Andersen interval running test is used for indirect estimation of maximal oxygen uptake.

  2. health knowledge, questionnaires [ Time Frame: baseline, 10 weeks, follow-up - 3 and 12 months ]
    The participant's health knowledge is measured using a questionnaire that examines their learning and understanding of the 11 health messages.

  3. well-being, questionnaires [ Time Frame: baseline, 10 weeks, follow-up - 3 and 12 months ]
    a PedsQL questionnaire as well as a Kids Screen questionnaire

  4. BMI [ Time Frame: baseline, 10 weeks, follow-up - 3 and 12 months ]
    weight (in kg) and height (in meters) will be combined to report BMI in kg/m^2


Other Outcome Measures:
  1. muscle mass, portable body composition analyser (InBody 720) [ Time Frame: baseline, 10 weeks, follow-up - 3 and 12 months ]
    The InBody 720 also provides an estimate of muscle mass and fat percentage.

  2. sleep patterns, questionnaires [ Time Frame: baseline, 10 weeks, follow-up - 12 months ]
    The Children's Sleep Habits Questionnaire (CSHQ)

  3. daily activity patterns, accelerometre [ Time Frame: baseline, 10 weeks, follow-up - 12 months ]
    accelerometre

  4. insulin level [ Time Frame: baseline, 10 weeks, follow-up - 12 months ]
    saliva samples

  5. cortisol level [ Time Frame: baseline, 10 weeks, follow-up - 12 months ]
    hair samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647007


Contacts
Layout table for location contacts
Contact: Trine K Møller +45 65509656 tmoller@health.sdu.dk

Locations
Layout table for location information
Denmark
Skælskør Julemærkehjem Recruiting
Skælskør, Region Sjælland, Denmark, 4230
Contact: Trine Møller       tmoller@health.sdu.dk   
Contact: Peter Krustrup       pkrustrup@health.sdu.dk   
Kildemose Julemærkehjem Recruiting
Ølsted, Region Sjælland, Denmark, 3310
Contact: Trine Møller       tmoller@health.sdu.dk   
Contact: Peter Krustrup       pkrustrup@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Peter Krustrup University of Southern Denmark
  Study Documents (Full-Text)

Documents provided by Peter Krustrup, University of Southern Denmark:

Layout table for additonal information
Responsible Party: Peter Krustrup, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03647007     History of Changes
Other Study ID Numbers: Christmas Seal Home Project
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Krustrup, University of Southern Denmark:
fat percentage
physical fitness
well-being
small-sided games

Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms