Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
260 participants
INTERVENTIONAL
2008-08-31
2015-11-30
Brief Summary
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Detailed Description
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The primary outcome variable, BMI of the children, is measured at inclusion, after six months, at exclusion and one year after end of program.
Following variables are investigated and related to BMI of children before and after intervention: Heredity: BMI of parents, history . Socio-economic background: education, salary, language, occupation of parents. Perinatal data: Mothers BMI, parity, smoking, ponderal index of infant, gender, breast-feeding. Psychological variables: grading of parents experienced stress and control and psychological health of the child, before end after intervention. Are there a correlation between change in these factors and change in BMI of the child after the intervention? Physiological variables: Sleep duration and activity patterns in the children and compare them to BMI Analysing sleep duration and activity with an accelerometer. Analysing dietary of children: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention: metabolism of insulin (glc, insulin, C-peptide, pro-insulin, HBA1C) lipids (TG, HDL, LDL, cholesterole), adipokins and cytokins (leptin, adinopektin, resistin, haptoglobulin, IL-6, TNFalfa),ghrelin before and after a meal, thyroid (TSH, T3). Analysing the bacteria of the gastro-intestinal tract by sample from stools.
Utilization of SundaBarn.se: automatic, electronic measurement by single user identity of number of sessions, pages visited, inputs made and downloads.
Intervention health-care resource use: Protocol driven visits to physician, nurse, occupational therapist, psychologist, dietitian.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: experimental
(A) internet based information and communication tool "Sundabarn.se"(
Obesity-Children
(A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group.
(B): experimental
(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A
Obesity-Children
(A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group.
(c): experimental
(C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A
Obesity-Children
(A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group.
(D): control group
Obesity-Children
(A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group.
Interventions
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Obesity-Children
(A) internet based information and communication tool "Sundabarn.se"(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A, (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A, (D) control group.
Eligibility Criteria
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Inclusion Criteria
* BMI due to Cole criteria as overweight or obesity
Exclusion Criteria
* Endocrine disorders
4 Years
5 Years
ALL
No
Sponsors
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Lund University Hospital
OTHER
Vardalinstitutet The Swedish Institute for Health Sciences
OTHER
Responsible Party
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Lund university Hospital
Locations
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Lund University Childrens' hospital
Lund, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Onnerfalt J, Erlandsson LK, Orban K, Broberg M, Helgason C, Thorngren-Jerneck K. A family-based intervention targeting parents of preschool children with overweight and obesity: conceptual framework and study design of LOOPS- Lund overweight and obesity preschool study. BMC Public Health. 2012 Oct 17;12:879. doi: 10.1186/1471-2458-12-879.
Other Identifiers
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Obesity-Chrildren Vardal
Identifier Type: -
Identifier Source: org_study_id
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