The Odense Overweight Intervention Study (OOIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Lars Bo Andersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01574352
First received: March 26, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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 42 weeks of family support.

The study hypothesis is that participating in a 6 week resident camp and a following period of 42 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 Intervention
Children
Overweight
Obesity
Metabolic Syndrome
Behavioral: Small intervention
Behavioral: Intervention camp

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Odense Overweight Intervention Study (OOIS): A Randomized Controlled Trial on Overweight Prevention in Children.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Change from baseline in Body Mass Index at 12 months [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    To calculate body mass index, height and weight will assessed


Secondary Outcome Measures:
  • Change from baseline in Cognitive function at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 from baseline in Motor skills at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    To assess motor skills the Movement ABC-2 test for 11-16 year olds are applied.

  • Change from baseline in Body composition at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    Measurements of fat mass and lean tissue mass will be done using dual-energy X-ray absorptiometry.

  • Change from baseline in Brain-derived neurotrophic factor (BDNF) at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 (IMT) and Carotid Elasticity at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 from baseline in Cardio-respiratory fitness at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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: 6 - 4 weeks before, immediately after (over 2 weeks), and 12 months after a 6 week intervention period. ] [ Designated as safety issue: No ]
    The level of insulin is assessed in fasting blood samples.

  • Change from baseline in Glucose level at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    The level of glucose is assessed in fasting blood samples.

  • Change from baseline in Blood Lipids at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    The levels of lipids are assessed in fasting blood samples.

  • Change from baseline in C-Reactive Protein at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 from baseline in Clustered CVD risk factor score at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    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 from baseline in Physical strength at 12 months. [ Time Frame: Assessed on 3 occations; 6 - 4 weeks before, immediately after (over 2 weeks), and 44 weeks after a 6 week intervention period. ] [ Designated as safety issue: No ]
    Will be measured by hand grip and Sargent vertical jump.


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: July 2017
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   10 Years to 13 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574352

Locations
Denmark
University of Southern Denmark
Odense, Funen, Denmark, 5230
Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Lars Bo Andersen, Professor Center of Research in Childhood Health (RICH), University of Southern Denmark
  More Information

Additional Information:
No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Bo Andersen, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01574352     History of Changes
Other Study ID Numbers: S20120015
Study First Received: March 26, 2012
Last Updated: July 2, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by 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:
Obesity
Overweight
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014