Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01574352
Status:
UNKNOWN
Last Update Posted:
2020-11-19
First Post:
2012-03-26
Brief Title:
The Odense Overweight Intervention Study
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
The Odense Overweight Intervention Study OOIS A Randomized Controlled Trial on Overweight Prevention in Children
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OOIS
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
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 recommendations15 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 am to 830 pm 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 parentslegal 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
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 recommendations15 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 am to 830 pm 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 parentslegal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None