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Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children (STOPP-8)

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Karolinska Institute

Status

Withdrawn

Conditions

Overweight
Sedentary Lifestyle
Cardiovascular Risk Factors
Metabolic Risk Factors

Treatments

Behavioral: Motivational Interviewing
Behavioral: Physical activity
Dietary Supplement: Placebo oil capsules
Dietary Supplement: Supplementation with fish liver oli capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT01087411
2008/1116-31/2 (Other Identifier)
STOPP-8

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

7 to 9 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 4 patient groups, including a placebo group

Motivational Interviewing and omega 3
Experimental group
Description:
This arm is the group that receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants.
Treatment:
Dietary Supplement: Supplementation with fish liver oli capsules
Behavioral: Physical activity
Behavioral: Motivational Interviewing
Motivational interviewing and placebo
Experimental group
Description:
This arm is the group that receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants.
Treatment:
Dietary Supplement: Placebo oil capsules
Behavioral: Physical activity
Behavioral: Motivational Interviewing
Control and omega 3
Experimental group
Description:
This arm is the group that does not receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants.
Treatment:
Dietary Supplement: Supplementation with fish liver oli capsules
Control and placebo
Placebo Comparator group
Description:
This arm is the group that does not receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants.
Treatment:
Dietary Supplement: Placebo oil capsules

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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