Childhood ObesityNCT00916318
Childhood Overweight
A study testing Obesity-Children in people with Childhood Obesity and Childhood Overweight, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Childhood Obesity, Childhood Overweight
- What is being tested?
- Obesity-Children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4-6 y
- BMI due to Cole criteria as overweight or obesity
Who cannot join
- Medical disorders
- Endocrine disorders
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Lund University Childrens' hospital
Lund
Kristina Thorngren-Jerneck, phd, Kristina.Thorngren-Jerneck@med.lu.se
About this study
Official title: Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health
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.
Read the 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.
- Conditions
- Childhood Obesity, Childhood Overweight
- Being tested
- Obesity-Children
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obesity-ChildrenBehavioural
(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.
| Study group | Role | What they receive |
|---|---|---|
| A: experimental | Experimental | (A) internet based information and communication tool "Sundabarn.se"( Receives: Behavioral: Obesity-Children |
| (B): experimental | Experimental | (B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A Receives: Behavioral: Obesity-Children |
| (c): experimental | Experimental | (C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A Receives: Behavioral: Obesity-Children |
| (D): control group | Active comparator | Not described Receives: Behavioral: Obesity-Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: BMI
Measured: 6 months, 1 year, 2 year, 5 year
Secondary outcomes (1)
Secondary Outcome Measures: diet registration Analysing the change of bio-chemical markers in blood of children before and after intervention
Measured: 6 months, 1 year, 2 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2010 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916318
- Sponsor's protocol ID
- Obesity-Chrildren Vardal
- Status last verified
- May 2009
- First submitted
- 5 Jun 2009
- Last updated
- 9 Jun 2009
- Results posted
- No
Publications
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.
PubMed 23072247
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health
- ClinicalTrials.gov ID
- NCT00916318
- Acronym / sponsor ID
- Obesity-Chrildren Vardal
- Conditions
- Childhood Obesity, Childhood Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
- Collaborators
- Lund University Hospital
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: experimental | Experimental | Behavioral: Obesity-Children(A) internet based information and communication tool "Sundabarn.se"( |
| (B): experimental | Experimental | Behavioral: Obesity-Children(B) psychologist directed seminars with different themes, giving parents tools to implement necessary changes in family-patterns and life style, combined with A |
| (c): experimental | Experimental | Behavioral: Obesity-Children(C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A |
| (D): control group | Active comparator | Behavioral: Obesity-Children |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 4-6 y
- BMI due to Cole criteria as overweight or obesity
Key exclusion criteria (2 listed)
- Medical disorders
- Endocrine disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | (B): experimental, (D): control group, (c): experimental, A: experimental |
Primary outcome
Primary Outcome Measure: BMI
Time frame: 6 months, 1 year, 2 year, 5 year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2009.
- Derived from this study: PubMed 23072247Onnerfalt 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.
Related trials for Childhood Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obesity-Children in people with Childhood Obesity and Childhood Overweight, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristian Bolin, phd (+46 46 2228655, Kristian.Bolin@nek.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: BMI (time frame: 6 months, 1 year, 2 year, 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2009.