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The Odense Overweight Intervention Study (OOIS)

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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

Tracking Information
First Submitted Date  ICMJE March 26, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE October 24, 2017
Results First Posted Date  ICMJE November 19, 2020
Last Update Posted Date November 19, 2020
Study Start Date  ICMJE April 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
change in Body Mass Index [ Time Frame: 6 - 4 weeks before and immediately after (over 2 weeks) a 6 week intervention period. ]
To calculate body mass index, height and weight will assessed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2012)
  • change in Cognitive function [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    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.
  • change in Motor skills [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    To assess motor skills the Movement ABC-2 test for 11-16 year olds are applied.
  • change in Body composition [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    Measurements of fat mass and lean tissue mass will be done using dual-energy X-ray absorptiometry.
  • change in Brain-derived neurotrophic factor (BDNF) [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    The chronic level of serum brain-derived neurotrophic factor (BDNF) is assessed in fasting blood samples.
  • change in Blood pressure [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    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.
  • change in Subclinical atherosclerosis using B-mode ultrasound: Carotid Intima Media Thickness (IMT) and Carotid Elasticity [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    The IMT is 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.
  • change in Cardio-respiratory fitness [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    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).
  • change in Insulin [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    The level of insulin is assessed in fasting blood samples.
  • change in Glucose [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    The level of glucose is assessed in fasting blood samples.
  • change in Lipids [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    The levels of lipids are assessed in fasting blood samples.
  • change in C-Reactive Protein [ Time Frame: Last week before, first week after and 12 months after a 6 week intervention period. ]
    The level of c-reactive-protein is assessed in fasting blood samples.
  • change in waist/hip circumference [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. Finally after 48 months. ]
    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.
  • change in Clustered CVD risk factor score [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    The clustered risk factors are the mutual presence of several of the above mentioned health outcomes. It is calculated by summing z-scores of metabolic syndrome risk factors
  • change in Physical strength [ Time Frame: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ]
    Will be measured by hand grip and Sargent vertical jump.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Odense Overweight Intervention Study
Official Title  ICMJE The Odense Overweight Intervention Study (OOIS): A Randomized Controlled Trial on Overweight Prevention in Children.
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.

Detailed Description

Intervention type 1: Day camp and resident camp:

The intervention is divided into two parts - an intensive six week day or resident camp with a subsequent ten month follow-up intervention program. The children participate in a six week day camp where they are engaged in fun-based physical activity and sports, health classes as well as math lessons, Danish language and science classes. All classes are planned and conducted by health professionals and specialist instructors. All physical activity classes are primarily held using outdoor recreational facilities such as soccer fields, basketball courts, and forest areas within bicycling distance to the camp. Three hours of physical activity and sports are scheduled every day, and the classes are designed to reinforce motor skills, fitness, muscle strength, and confidence within the sporting environment. The planned sports activities are both competitive and non-competitive providing the children with both positive experiences in relation to physical activity and tools to cope with competitive situations in their normal environment including commuter bicycling. Bicycles are available for all children. Beside scheduled physical activity the children are encouraged to stay physically active during breaks and leisure time. Six hours a week health classes with the purpose of increasing their knowledge on health issues such as the benefits of a healthy diet and sports participation and increasing body awareness are scheduled. The classes consist of nutritional training, physiology, exercise and goal setting. For this purpose "Appreciative Inquiry" (AI) is used. Briefly, this deals with inquiry into and dialogue about strengths, successes, values, hopes and dreams related to lifestyle behaviors.

The nutritional education consists of theoretical education in the national Danish dietary recommendations in combination with personal guidance at every meal. At the camp food intake is prepared and served according to the national Danish dietary recommendations.(15) The actual eating situation is supervised and guided by specialist instructors, but no calorie restriction is enforced. All camp staff will receive extensive training by specialist instructors with in the field of pedagogic and psychology.

Intervention arm specifications:

Children allocated to this intervention arm will stay at a day camp from 7 a.m. to 8.30 p.m. seven days a week during six weeks including transportation to the day camp. The children will stay at home with their parents outside this time period. The camp is located in the city of Odense, Denmark. The children, together with their family, participate in an initial counseling session. The aim is to support the participants in their efforts to uphold the designed program on diet and food intake. Following this session, the families sign a so-called commitment contract confirming their continuing involvement. During the intervention, text messages will be sent to the children in order to help them comply with the program, and the parents will receive a handbook on dietary recommendations. The children will commute using bicycles to and from the school camp in combination with parent transportation. The children will commute in smaller groups arranged according to the residential area. Active commuting will be supervised and arranged by the camp instructors. Parent transportation will be coordinated by the camp staff.

Early parent involvement - Intervention and Satellite arm:

In the beginning of the intervention a parent council is founded. Experiences from the resident camp project have revealed a positive influence regarding networking and general parent involvement and support due to the foundation of an active parent council (personal communication).

During the day camp the families are offered a dietary course, led by a dietician, consisting of 3x2 hour meetings. Themes at the course are; Healthy cooking, Grocery Shopping, Healthy Eating Patterns in their every day context and parental influence on physical activity behavior.

The subsequent family-based intervention- Intervention and Satellite arm:

After the six week intervention, a family based intervention consisting of four meetings will be planned with the family (the participant and their parents/legal guardian) targeting physical activity and dietary behavior delivered by school health nurses and teachers from the day camp intervention. The following four themes will be attended during the four meetings: "Everyday diet for the family", "Active transport and sports participation", "Weight management in the family" and "Networking and support". Appreciative Inquiry (AI) will be used as a method to equip families with a method to handle challenges related to the targeted behaviors. At all meetings the families will discuss and share experiences related to the central topic of the meeting. The children must be accompanied by at least one parent or legal guardian during the meetings. The investigators have had promising results and feedback from children and families as regards using AI during the family based intervention in the pilot study.

Intervention type 2- control group: Standard intervention:

Children allocated to this intervention will receive a standard intervention, which consist of: 1) one weekly physical activity session (one hour duration) for six weeks arranged by the municipality; 2) two educational sessions, delivered by a dietician and physical activity specialist, for the parents concerning diet and physical activity behavior.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Children
  • Overweight
  • Obesity
  • Metabolic Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Intervention camp
  • Experimental: Small intervention
    Children are only informed of healthy behavior
    Intervention: Behavioral: Small intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 14, 2020)
115
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2012)
100
Estimated Study Completion Date  ICMJE July 2021
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574352
Other Study ID Numbers  ICMJE S20120015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Responsible Party Lars Bo Andersen, University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE TrygFonden, Denmark
Investigators  ICMJE
Principal Investigator: Lars Bo Andersen, Professor Center of Research in Childhood Health (RICH), University of Southern Denmark
PRS Account University of Southern Denmark
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP