Childhood Overweight

Childhood Obesity Clinical Trial

Official title:

Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00916318
• Other study ID #: Obesity-Chrildren Vardal
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2009
• Last updated: June 8, 2009
• Start date: August 2008
• Est. completion date: November 2015

Study information

• Verified date: May 2009
• Source: Vardalinstitutet The Swedish Institute for Health Sciences
• Contact: Kristian Bolin, phd
• Phone: +46 46 2228655
• Email: Kristian.Bolin[@]nek.lu.se
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: November 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 5 Years

Eligibility

Inclusion Criteria:

• 4-6 y

• BMI due to Cole criteria as overweight or obesity

Exclusion Criteria:

• Medical disorders

• Endocrine disorders

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Childhood Overweight
• Overweight
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Sweden	Lund University Childrens' hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Vardalinstitutet The Swedish Institute for Health Sciences	Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure: BMI		6 months, 1 year, 2 year, 5 year	No
Secondary	Secondary Outcome Measures: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention		6 months, 1 year, 2 year, 5 year	No