Childhood Overweight

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2009 by Vardalinstitutet The Swedish Institute for Health Sciences
Sponsor:
Collaborator:
Lund University Hospital
Information provided by:
Vardalinstitutet The Swedish Institute for Health Sciences
ClinicalTrials.gov Identifier:
NCT00916318
First received: June 5, 2009
Last updated: June 8, 2009
Last verified: May 2009
  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

Resource links provided by NLM:


Further study details as provided by Vardalinstitutet The Swedish Institute for Health Sciences:

Primary Outcome Measures:
  • Primary Outcome Measure: BMI [ Time Frame: 6 months, 1 year, 2 year, 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • 4-6 y
  • BMI due to Cole criteria as overweight or obesity

Exclusion Criteria:

  • Medical disorders
  • Endocrine disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916318

Contacts
Contact: Kristian Bolin, phd +46 46 2228655 Kristian.Bolin@nek.lu.se

Locations
Sweden
Lund University Childrens' hospital Recruiting
Lund, Sweden
Contact: Kristina Thorngren-Jerneck , phd       Kristina.Thorngren-Jerneck@med.lu.se   
Sponsors and Collaborators
Vardalinstitutet The Swedish Institute for Health Sciences
Lund University Hospital
  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
Pediatric Obesity
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014