Cardiovascular Risk FactorsSTOPP-8NCT01087411
Intervention Study to Prevent Obesity in Sedentary 8 Year Old Swedish Children
A study testing Motivational Interviewing, Physical activity and Supplementation with fish liver oli capsules in people with Cardiovascular Risk Factors and Metabolic Risk Factors, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Metabolic Risk Factors, Sedentary Lifestyle
- What is being tested?
- Motivational Interviewing, Physical activity and Supplementation with fish liver oli capsules
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Dept. of Clinical Science, Intervention and Technology (CLINTEC), Division of Pediatrics.
Huddinge, Södermanland County, 14186
About this study
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
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.
Read the 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.
- Being tested
- Motivational Interviewing, Physical activity, Supplementation with fish liver oli capsules, Placebo oil capsules
- Keywords
- accelerometry, physical activity, obesity, children, cardiovascular risk markers, metabolic risk markers, DXA, obesity prevention, omega 3, fish liver oil, motivational interviewing
- Medical subject headings
- Sedentary Behavior, Overweight, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Physical activityBehavioural
Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.
Supplementation with fish liver oli capsulesDietary supplement
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.
Placebo oil capsulesDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing and omega 3 | Experimental | This arm is the group that receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants. Receives: Behavioral: Motivational Interviewing; Behavioral: Physical activity; Dietary Supplement: Supplementation with fish liver oli capsules |
| Motivational interviewing and placebo | Experimental | This arm is the group that receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants. Receives: Behavioral: Motivational Interviewing; Behavioral: Physical activity; Dietary Supplement: Placebo oil capsules |
| Control and omega 3 | Experimental | This arm is the group that does not receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants. Receives: Dietary Supplement: Supplementation with fish liver oli capsules |
| Control and placebo | Placebo comparator | This arm is the group that does not receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants. Receives: Dietary Supplement: Placebo oil capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of physical activity
Physical activity, is measured with tri-axis accelerometers of the brand Actigraph model GT3X. Data is collected every 10 seconds during 7 consecutive whole days. It is the most feasible and precise method for the purpose.
Measured: screening, 0 and 15 weeks and 12 months
Secondary outcomes (7)
Body composition
Dual Energy X-ray Absorbtiometry (body composition and Bone mass density). Brand: General Electronics Health Care; Model: iDXA. It is a non-invasive method using x-ray and computer technology to assess the proportions of fat mass, lean mass and bone mass and to measure the bone mass density. The method is widely used and does not mean any direct increased risk. The amount of x-ray is equivalent to the amount individuals get exposed from their natural environment during an average day in free living conditions.
Measured: 0 and 15 weeks
Cardiovascular risk markers
Blood sample is collected from all participants in the intervention program (all 4 arms). However, this will not be decisive for inclusion in the study. Parents will be thoroughly informed of the procedure of blood sampling (i.e. local anaesthesia) and that they can choose not to participate in this part of the study. Fasting blood samples will be analyzed for LDL-C, HDL-C, tot-C, TG, Lp(a), hsCRP, TNF-α, IL6, IL1, PAI-1, glucose, Apo A-1, Apo B, adiponectin, leptin, insulin, omega-3 and FTO-gene expression.
Measured: 0 and 15 seeks
BMI (Body Mass Index)
The childrens' height and weight is recorded via standardized and calibrated scales and stadiometer.
Measured: 0 and 15 weeks
Quality of life scale
A validated questionnaire including self report for subjective feeling of quality of life are filled out by each child with assistance of an adult (parent or teacher)
Measured: 0 and 15 weeks
Self reported motor skills
A validated questionnaire including self report motor skills e are filled out by each child with assistance of an adult (parent or teacher)
Measured: 0 and 15 weeks
Self reported physical activity
A validated questionnaire including self report for physical activity are filled out by each child with assistance of an adult (parent or teacher)
Measured: 0 and 15 weeks
Physical fitness
An ergometer bicycle test is performed by each child at baseline to assess the level of physical fitness. It is a sub-maximal test performed at a moderate intensity work load during 5 - 8 minutes. This test is performed to characterize the participants and the result (an indirect measure for oxygen uptake capacity and aerobic work capacity) is used to control and adjust the results by.
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2012
- Study completionDec 2012
Why it stopped: 2010 represented complications recruiting. The team suffered from sick-leave.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pernilla Danielsson, Karolinska Institutet
- Investigators
- Pernilla Danielsson Liljeqvist, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087411
- Sponsor's protocol ID
- STOPP-8
- Other IDs
- 2008/1116-31/2
- Acronym
- STOPP-8
- Status last verified
- Feb 2021
- First submitted
- 15 Mar 2010
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01087411
- Acronym / sponsor ID
- STOPP-8 / STOPP-8
- Keywords
- accelerometry, physical activity, obesity, children, cardiovascular risk markers, metabolic risk markers, DXA, obesity prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 2010 represented complications recruiting. The team suffered from sick-leave.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing and omega 3 | Experimental | Behavioral: Motivational Interviewing, Behavioral: Physical activity, Dietary Supplement: Supplementation with fish liver oli capsulesThis arm is the group that receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants. |
| Motivational interviewing and placebo | Experimental | Behavioral: Motivational Interviewing, Behavioral: Physical activity, Dietary Supplement: Placebo oil capsulesThis arm is the group that receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants. |
| Control and omega 3 | Experimental | Dietary Supplement: Supplementation with fish liver oli capsulesThis arm is the group that does not receives the intervention program and eats fish liver oil capsules. Represents 25 % of all participants. |
| Control and placebo | Placebo comparator | Dietary Supplement: Placebo oil capsulesThis arm is the group that does not receives the intervention program and eats placebo oil capsules. Represents 25 % of all participants. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingThe 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. | Behavioural | Motivational Interviewing and omega 3, Motivational interviewing and placebo |
| Physical activityGroup sessions with different kinds of physical activity is arranged for the participants in the intervention program. | Behavioural | Motivational Interviewing and omega 3, Motivational interviewing and placebo |
| Supplementation with fish liver oli capsulesThis 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 | Control and omega 3, Motivational Interviewing and omega 3 |
| Placebo oil capsulesThis 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. | Dietary supplement | Control and placebo, Motivational interviewing and placebo |
Primary outcome
Change in level of physical activity
Time frame: screening, 0 and 15 weeks and 12 months
Physical activity, is measured with tri-axis accelerometers of the brand Actigraph model GT3X. Data is collected every 10 seconds during 7 consecutive whole days. It is the most feasible and precise method for the purpose.
7 secondary outcomes
Body composition
Time frame: 0 and 15 weeks
Cardiovascular risk markers
Time frame: 0 and 15 seeks
BMI (Body Mass Index)
Time frame: 0 and 15 weeks
Quality of life scale
Time frame: 0 and 15 weeks
Self reported motor skills
Time frame: 0 and 15 weeks
Self reported physical activity
Time frame: 0 and 15 weeks
Physical fitness
Time frame: 0 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernilla Danielsson Liljeqvist, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing, Physical activity and Supplementation with fish liver oli capsules in people with Cardiovascular Risk Factors and Metabolic Risk Factors, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of physical activity (time frame: screening, 0 and 15 weeks and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.