Childhood Overweight
Primary Purpose
Childhood Obesity, Childhood Overweight
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Obesity-Children
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity
Eligibility Criteria
Inclusion Criteria:
- 4-6 y
- BMI due to Cole criteria as overweight or obesity
Exclusion Criteria:
- Medical disorders
- Endocrine disorders
Sites / Locations
- Lund University Childrens' hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
A: experimental
(B): experimental
(c): experimental
(D): control group
Arm Description
(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
Outcomes
Primary Outcome Measures
Primary Outcome Measure: BMI
Secondary Outcome Measures
Secondary Outcome Measures: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention
Full Information
NCT ID
NCT00916318
First Posted
June 5, 2009
Last Updated
June 8, 2009
Sponsor
Vardalinstitutet The Swedish Institute for Health Sciences
Collaborators
Lund University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00916318
Brief Title
Childhood Overweight
Official Title
Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Vardalinstitutet The Swedish Institute for Health Sciences
Collaborators
Lund University Hospital
4. Oversight
5. Study Description
Brief Summary
To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program.
Detailed Description
The aim is to investigate the possibility of preventing the development of obesity in early childhood. To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. To compare different methods of treatment by randomizing the families into groups with various treatment during one year; (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. To analyse the aetiology and prognosis of overweight and obesity in early childhood, by measuring the following variables: heredity, genetics, perinatal, physiological, metabolism, bio-chemical, clinical, psychological, socio-economic. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program. To calculate the prevalence of overweight and obesity among pre-school children in the county of Middle Skåne during a 20 year period. To analyse parents actual utilization of the Sundabarn.se and in association with primary and secondary outcome. To analyse the cost-effectiveness of the intervention programs.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Childhood Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A: experimental
Arm Type
Experimental
Arm Description
(A) internet based information and communication tool "Sundabarn.se"(
Arm Title
(B): experimental
Arm Type
Experimental
Arm Description
(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A
Arm Title
(c): experimental
Arm Type
Experimental
Arm Description
(C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A
Arm Title
(D): control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Obesity-Children
Intervention Description
(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.
Primary Outcome Measure Information:
Title
Primary Outcome Measure: BMI
Time Frame
6 months, 1 year, 2 year, 5 year
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention
Time Frame
6 months, 1 year, 2 year, 5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
4-6 y
BMI due to Cole criteria as overweight or obesity
Exclusion Criteria:
Medical disorders
Endocrine disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristian Bolin, phd
Phone
+46 46 2228655
Email
Kristian.Bolin@nek.lu.se
Facility Information:
Facility Name
Lund University Childrens' hospital
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Thorngren-Jerneck, phd
Email
Kristina.Thorngren-Jerneck@med.lu.se
12. IPD Sharing Statement
Citations:
PubMed Identifier
23072247
Citation
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.
Results Reference
derived
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Childhood Overweight
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