Childhood Overweight
Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health
1 other identifier
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2009
CompletedFirst Posted
Study publicly available on registry
June 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJune 9, 2009
May 1, 2009
2.3 years
June 5, 2009
June 8, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measure: BMI
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
6 months, 1 year, 2 year, 5 year
Study Arms (4)
A: experimental
EXPERIMENTAL(A) internet based information and communication tool "Sundabarn.se"(
(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
(c): experimental
EXPERIMENTAL(C) occupational therapist directed group-treatment intended to help parents alter their daily life patterns and, combined with A
(D): control group
ACTIVE COMPARATORInterventions
(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.
Eligibility Criteria
You may qualify if:
- BMI due to Cole criteria as overweight or obesity
You may not qualify if:
- Medical disorders
- Endocrine disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lund University Childrens' hospital
Lund, Sweden
Related Publications (1)
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.
PMID: 23072247DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 5, 2009
First Posted
June 9, 2009
Study Start
August 1, 2008
Primary Completion
December 1, 2010
Study Completion
November 1, 2015
Last Updated
June 9, 2009
Record last verified: 2009-05