NCT01087411

Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Risk Factors
• Metabolic Risk Factors
• Sedentary Lifestyle
• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Motivational Interviewing	The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.
BEHAVIORAL	Physical activity	Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.
DIETARY_SUPPLEMENT	Supplementation with fish liver oli capsules	This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.
DIETARY_SUPPLEMENT	Placebo oil capsules	This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-03-16
• Last updated: 2021-02-24

Locations

1 site across 1 country: Sweden