Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Odense Overweight Intervention Study (OOIS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574352
Recruitment Status : Active, not recruiting
First Posted : April 10, 2012
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Lars Bo Andersen, University of Southern Denmark

Brief Summary:

Strong and consistent evidence have shown that overweight, including obesity, is an important risk factor for the development of cardiovascular disease (CVD) in adults. Several studies have found an association between overweight in childhood and increased risk of morbidity and mortality later in life. The prevalence of overweight in children and adolescents has increased in recent years, and consequently it is important to identify effective approaches in the prevention and treatment of overweight in young individuals.

Approaches such as resident weight loss camps have shown promising results. A residential camp setting provides an opportunity to increase and control exposure to, for instance, particular foodstuffs, beverages and physical activity opportunities. However, well-designed studies with sufficient participants are still needed on the reversal of overweight in childhood with increased focus on documenting predictors of behavior changes associated with decreases in overweight.

This study is carried through as a randomized controlled trial which investigates the effect of participating in a 6 week health promoting resident for overweight fifth grade children camp followed by 46 weeks of family support.

The study hypothesis is that participating in a 6 week resident camp and a following period of 46 weeks of child and family support will induce a reduction in body mass index (BMI). In addition it is expected that the intensity and duration intervention program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.


Condition or disease Intervention/treatment Phase
Children Overweight Obesity Metabolic Syndrome Behavioral: Small intervention Behavioral: Intervention camp Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Odense Overweight Intervention Study (OOIS): A Randomized Controlled Trial on Overweight Prevention in Children.
Study Start Date : April 2012
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Intervention camp
Children's behavior are controlled each week day for six weeks, and children participate in three hours of physical activity every day
Behavioral: Intervention camp
The children are participating in a 6 week day camp. The camp contains social activities, physical activity training, usual school classes and health education. All meals (healthy food) are consumed during the camp day.
Other Names:
  • Behavioral intervention
  • Camp intervention
  • Physical activity intervention

Experimental: Small intervention
Children are only informed of healthy behavior
Behavioral: Small intervention
The control group are offered a weekly 1 hour training or activity session during six weeks. Furthermore two sessions where the parents are invited to participate in information about diet and exercise.
Other Name: control group




Primary Outcome Measures :
  1. Change in BMI From Baseline to 12 Months Follow up. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]

    Change in Body Mass Index (BMI) for each intervention arm from baseline (4-6 weeks prior to intervention) to 12 months follow up. BMI is defined as kg/m^2.

    Although three measurements have been conducted, we only report the first and last.



Secondary Outcome Measures :
  1. Change in Cognitive Function From Baseline to 12 Months Follow up. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    To assess cognitive function the following test are used: The Stroop Color and word test; Trail making test (part A and B); Rey complex figure test and recognition trial; Symbol digit modalities Test; Behavior rating inventory of executive function.

  2. Change in Motor Skills From Baseline to 12 Months Follow up. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    To assess motor skills, the Movement Assesment Battery for Children 2 (Movement ABC-2) test for 11-16 year olds was applied. The battery allows for recording a number of different aspects of a child's movement skills in a systematic way. In this study we only used the quantitative part of the test (it also includes a qualitative part). This includes 3 tests for hand skills (fine motor skills), 2 tests for throwing and catching balls, and 3 tests for balance skills. Each subtest returns a score, which is summarized and then equivalent to a percentile score (based on norm data from a standard population in a table from the Movement ABC-2 compendium). The percentile score is reported as the overall motor skills. The scale is from 0.1 to 99.9 (normal distributed with an average of 50) and higher scores mean better motor skills.

  3. Change in Body Composition From Baseline to 12 Months Follow up. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    Measurements of fat mass and lean tissue mass using dual-energy X-ray absorptiometry.

  4. Change From Baseline in Brain-derived Neurotrophic Factor (BDNF) at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The chronic level of serum brain-derived neurotrophic factor (BDNF) is assessed in fasting blood samples.

  5. Change From Baseline in Blood Pressure at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    Blood pressure will be measured in up-right sitting position after resting supine for ten minutes. A minimum of five measurements will be conducted with one minute intervals.

  6. Change From Baseline in Subclinical Atherosclerosis Using B-mode Ultrasound: Carotid Intima Media Thickness and Carotid Elasticity at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The Carotid Intima Media and Carotid Elasticity are measured on 2 sites (posterior and lateral) of the far wall 1 cm proximal to the bifurcation on both sides of the common carotid artery.

  7. Change From Baseline in Cardio-respiratory Fitness at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    Cardio-respiratory fitness will be assessed using a progressive bicycle ergometer protocol after a 5 minutes warm-up by means of indirect calorimetry (Innovision, Odense, Denmark).

  8. Change From Baseline in Insulin Level at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The level of insulin is assessed in fasting blood samples.

  9. Change From Baseline in Glucose Level at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The level of glucose is assessed in fasting blood samples.

  10. Change From Baseline in Blood Lipids at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The levels of lipids are assessed in fasting blood samples.

  11. Change From Baseline in C-Reactive Protein at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The level of c-reactive-protein is assessed in fasting blood samples.

  12. Change From Baseline in Waist/Hip Circumference at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    Hip circumference will be measured at the level of the great trochanter. Waist circumference will be measured between the lower costal margin and the iliac crest.

  13. Change in Clustered Cardiovascular Disease (CVD) Risk Factor [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    The CVD risk factor is the mutual presence of five different health outcomes based on the Metabolic Syndrome. It is calculated by creating a composite risk score (mean of z-scores) of: 1) Insulin resistance (Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)), 2) Systolic blood pressure, 3) triglyceride, 4) total cholesterol/HDL ratio, 5) Abdominal fatness (by Dual-energy X-ray absorptiometry (DXA)), and 6) aerobic fitness.

  14. Change From Baseline in Physical Strength at 12 Months. [ Time Frame: Assessed on 2 occasions: 1) Baseline measurements: 4 - 6 weeks before initiation of interventions. 2) 2nd follow up: 52-53 weeks (12 months) after initiation of interventions. ]
    Will be measured by hand grip and Sargent vertical jump.



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:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children in the municipality of Odense, Denmark
  • Overweight or obese (BMI) according to the International Obesity Task Force

Exclusion Criteria:

  • Children who are participating in other research based intervention programmes related to risk factors of heart diseases.
  • Children who are following a special school programme.
  • Use of weight reducing medicine within 3 months before the baseline measurements
  • Children with a motor skill determined handicap of such complexity that it hinders them from participating in the intervention.

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): NCT01574352


Locations
Layout table for location information
Denmark
Odense University Hospital
Odense, Funen, Denmark, 5000
University of Southern Denmark
Odense, Funen, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
TrygFonden, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Lars Bo Andersen, Professor Center of Research in Childhood Health (RICH), University of Southern Denmark
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lars Bo Andersen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01574352    
Other Study ID Numbers: S20120015
First Posted: April 10, 2012    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is available on request from The Danish National Archives (http://dda.dk/catalogue/30519) after August 2016.
Time Frame: After August 2016
Access Criteria:
  1. Data can only be used for scientific and statistical aims and reporting of aggregated information. Not for investigating affairs of private individuals or organisations.
  2. Data can under any circumstances be passed on to a third party, but only be utilized by the user(s) from the project application.
  3. Data can only be used for the purposes stated in the project application for the Danish National Archives.
  4. Considerable changes of the aim will require a new application.
  5. Any publication using the data from the project must bibliographically correct credit the Danish National Archives as well as the principal investigator. Publications must be send to the mailbox og the Danish National Archives attached as a file. The Danish National Archives will forward a copy to the principal investigator.
  6. After utilization of the data it must be deleted or returned to the Danish National Archives.
URL: http://dda.dk/catalogue/30519
Keywords provided by Lars Bo Andersen, University of Southern Denmark:
Children
Overweight
Obesity
BMI
Physical activity
Cognitive function
Intervention study
Randomized controlled trial
Day camp
Risk factors
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Syndrome
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases