Clinical trial NCT01087411: Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children
Official title: A Controlled Study Aiming to Increase Physical Activity and Decrease Risk Bio-markers in Sedentary 8 Year Old Swedish Children Via Physical Activity and Fish Liver Oil Supplementation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Risk Factors
Metabolic Risk Factors
Sedentary Lifestyle
Overweight
Keywords: accelerometry
physical activity
obesity
children
cardiovascular risk markers
metabolic risk markers
DXA
obesity prevention
omega 3
fish liver oil
motivational interviewing
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study whether a targeted intervention can increase physical activity in inactive 8-yr old children and how it affects secondary measures such as metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI, body composition and aerobic work-capacity.

Detailed description: Background Between 3 to 5 % of Swedish 10 yr olds are obese and an additional 20 % are over-weight. Being physically inactive in childhood increases the risk for becoming obese both in child- and adulthood and a correlation between BMI and arterial-sclerotic markers can be seen already in childhood. Physical activity (PA) in children improve their insulin sensitivity and reduce metabolic risk regardless of the proportion of fat mass. Published questionnaire data suggests that the level of PA has decreased in children between the years 1968 to 2001.

Study aims To study whether a targeted intervention can increase PA in sedentary 8-yr old children (2nd grade Swedish elementary school) and how it affects secondary measures such as; metabolic- and cardiovascular risk markers; self-reported quality of life, PA and motor skills; BMI; body composition; bone mineral density (BMD); PF. To identify factors of success that could be implemented in schools and pre-schools and in the commune and health-care parent support.

Subjects and methods With informed written consent of parents/caretakers we will screen at selected schools with questionnaires and accelerometers to identify sedentary children. The 30% most inactive children will be offered participation in the study. Cut off values for inactivity is obtained from a large reference-material based on 1800 measurements on 6 - 10 yr old children from the STOPP study. The intervention will be delivered through sessions aiming at developing healthy habits regarding PA and via supplementation with fish liver oil. The sessions will be performed by trained health workers (coaches) and carried out in the families' homes and later on via telephone. All families will meet with their coach during at least 6 times. The coaches will use the technique of Motivational Interviewing (MI). However, extra efforts, such as group work-out sessions and out-door activities, will be made. The individual work with these families is delicate and the intervention staff group will therefore have continuous education and guidance from a qualified MI tutor. All included children will be randomized to equally sized intervention or control group. All outcome measures will be assessed at 0 and 15 weeks (completion) of the intervention. The study is limited by the school semesters. Screening is therefore scheduled to the fall- and intervention program to spring semester.

Eligibility criteria: Inclusion Criteria:

* Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.

Exclusion Criteria:

* Family not being able to participate in the program or take part in at least the physical activity assessment.
* Morbidities that affects the outcome parameters.

Primary outcomes:
measure: Change in level of physical activity
timeFrame: screening, 0 and 15 weeks and 12 months
Secondary outcomes:
measure: Body composition
timeFrame: 0 and 15 weeks
measure: Cardiovascular risk markers
timeFrame: 0 and 15 seeks
measure: BMI (Body Mass Index)
timeFrame: 0 and 15 weeks
measure: Quality of life scale
timeFrame: 0 and 15 weeks
measure: Self reported motor skills
timeFrame: 0 and 15 weeks
measure: Self reported physical activity
timeFrame: 0 and 15 weeks
measure: Physical fitness
timeFrame: 0 weeks
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics.
state: Södermanland
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Danielsson Liljeqvist, MD
role: PRINCIPAL_INVESTIGATOR
References: