The Odense Overweight Intervention Study (OOIS)
|First Received Date ICMJE||March 26, 2012|
|Last Updated Date||July 2, 2014|
|Start Date ICMJE||April 2012|
|Primary Completion Date||July 2014 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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. ]
To calculate body mass index, height and weight will assessed
|Original Primary Outcome Measures ICMJE
||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||Complete list of historical versions of study NCT01574352 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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.|
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.
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||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||100|
|Estimated Completion Date||July 2017|
|Primary Completion Date||July 2014 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||10 Years to 13 Years (Child)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT01574352|
|Other Study ID Numbers ICMJE||S20120015|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Lars Bo Andersen, University of Southern Denmark|
|Study Sponsor ICMJE||University of Southern Denmark|
|Collaborators ICMJE||TrygFonden, Denmark|
|Information Provided By||University of Southern Denmark|
|Verification Date||July 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP