Childhood Overweight
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Childhood Obesity Childhood Overweight |
Behavioral: Obesity-Children |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health |
- Primary Outcome Measure: BMI [ Time Frame: 6 months, 1 year, 2 year, 5 year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 260 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A: experimental
(A) internet based information and communication tool "Sundabarn.se"(
|
Behavioral: 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.
|
|
Experimental: (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
|
Behavioral: 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.
|
|
Experimental: (c): experimental
(C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A
|
Behavioral: 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.
|
| Active Comparator: (D): control group |
Behavioral: 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.
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 4-6 y
- BMI due to Cole criteria as overweight or obesity
Exclusion Criteria:
- Medical disorders
- Endocrine disorders
Contacts and Locations| Contact: Kristian Bolin, phd | +46 46 2228655 | Kristian.Bolin@nek.lu.se |
| Sweden | |
| Lund University Childrens' hospital | Recruiting |
| Lund, Sweden | |
| Contact: Kristina Thorngren-Jerneck , phd Kristina.Thorngren-Jerneck@med.lu.se | |
More Information
Additional Information:
No publications provided by Vardalinstitutet The Swedish Institute for Health Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Principal investigator: Kristina Thorngren-Jerneck, Lund university Hospital |
| ClinicalTrials.gov Identifier: | NCT00916318 History of Changes |
| Other Study ID Numbers: | Obesity-Chrildren Vardal |
| Study First Received: | June 5, 2009 |
| Last Updated: | June 8, 2009 |
| Health Authority: | Sweden: Swedish National Council on Medical Ethics |
Additional relevant MeSH terms:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013