Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health"
"Population Activities in the Field of Prevention, Early Identification and Treatment of Overweight and Obesity in Gdansk Children and Youth Population"
1 other identifier
interventional
6,000
1 country
1
Brief Summary
"6-10-14 for Health" is an integrated weight-loss intervention programme for obese children from Gdansk municipality. Both participants of the programme and their family members are offered a 12-month integrated intervention, including medical, dietetic and psychological counselling, as well as educational workshops for parents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2011
Longer than P75 for not_applicable obesity
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
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedOctober 29, 2019
October 1, 2019
9.8 years
October 24, 2019
October 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
body mass change
Number (percentage) of participants with change of: body mass of 5% or centiles of BMI by 5 percentile points or z-score BMI change by 0,25
12 months from begining of intervention
Secondary Outcomes (1)
body fat reduction
12 months from begining of intervention
Study Arms (1)
intervention
OTHERmultidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer
Interventions
behavioral intervention - 4 visits with each of the specialist team (pediatrician, dietician, psychologist, physical activity specialist), (4 visits x 4 specialists). Each specialist ap. 30 min time. Wisits in 0-3m-6m-12m time frame. Visits focused on behavioral intervention - motivation for change and basic tools (dietician, physical activity specialist, psychologist) to implement change in nutrition and physical activity based on individual reediness for change (based on Prochaska model).
Eligibility Criteria
You may qualify if:
- children living in Gdansk (for screening phase)
- children with BMI above 85 percentile (for intervention phase)
- consent of parent/ caregivers
You may not qualify if:
- confirmed congenital or metabolic diseases connected with obesity risk
- lack of consent of parent/ caregivers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinical Center
Gdansk, 80-952, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Primary Investigator
Study Record Dates
First Submitted
October 24, 2019
First Posted
October 29, 2019
Study Start
April 1, 2011
Primary Completion
December 31, 2020
Study Completion
August 31, 2021
Last Updated
October 29, 2019
Record last verified: 2019-10