Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health"
Primary Purpose
Obesity, Obesity, Childhood, Health Program
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
multidisciplinary behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- children living in Gdansk (for screening phase)
- children with BMI above 85 percentile (for intervention phase)
- consent of parent/ caregivers
Exclusion Criteria:
- confirmed congenital or metabolic diseases connected with obesity risk
- lack of consent of parent/ caregivers
Sites / Locations
- University Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
intervention
Arm Description
multidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
body fat reduction
Number (percentage) of participants with change of body fat by at least 5%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04143074
Brief Title
Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health"
Official Title
"Population Activities in the Field of Prevention, Early Identification and Treatment of Overweight and Obesity in Gdansk Children and Youth Population"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2011 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michał Brzeziński
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
"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.
The programme, financed by the municipality of Gdansk, is devided in three phases:
Screening - all children aged 6, 9-11, 14 years of age from the City of Gdansk are being screened yearly. All children attending primary and grammar schools in Gdansk are subjected to a screening. The population size is between 9.000-10.000 children yearly.
All children have anthropometric measurements (body mass, body height, waist circumference), blood pressure, cardiorespiratory fitness.
Anthropometry: Body weight and body height are determined with a digital scale (Mensor WE150, Poland), with the child wearing an underwear and standing barefoot. Body height is measured to the nearest 0.001 m, and body weight to the nearest 0.1 kg. The scale is calibrated every day. Waist and hip circumferences are measured on a horizontal plane by an Ergonomic Circumference Measuring Tape (model 201; Seca GmbH & Co, KG, Hamburg, Germany).
Blood pressure measurement: Arterial blood pressure is determined oscillometrically (Omron) on the left arm, with a cuff of an adequate size placed at the level of the heart, in the child seated with uncrossed legs, following at least a 5-min rest in the seated position. The width of the inflatable cuff corresponds to at least 40% of arm circumference. Three separate measurements of blood pressure are taken and averaged.
Kasch pulse recovery step test: The participants are subjected to a 3-minute Kasch pulse recovery (KPR) step test. The test consists of climbing a 0.305 m step at a rate of 24 steps-up/-down per minute. The rate of climbing is defined by a metronome set at 96 beats (signals) per minute. Heart rate (HR) is monitored continuously with "Polar" (Finland) electronic analyser for 3 minutes of the exercise (step-test) and during 1 minute and 5 seconds of recovery in a seated position. Only post-exercise HR recorded within one minute, starting 5 seconds after completing the test, is subjected to analysis. All HR characteristics are recorded during restitution in a seated position (subjects are instructed to sit still, breath normally and not involve in a conversation). An arithmetic mean calculated from these values (HRmean post-ex) is subjected to further analyses.
Intervention - Participants whose anthropometric parameters correspond to overweight (BMI between the 85th and 95th percentile) or obesity (BMI > =95th percentile), according to the percentile charts developed within the framework of the OLAF project, for Poland were qualified to a complex educational and medical intervention for children at increased risk of civilization-related disorders.
Weight- loss intervention programme:
Dietetic consultation - analysis of nutritional behaviours and dietary habits, selection of appropriate diet. Dietetic consultation takes place at enrolment and 3, 6 and 12 months thereafter.
Psychological consultation - reinforcement of changes in health behaviours of the child and his/her parents.
Consultation with a physical education specialist - defining optimal level of physical activity, adjusted to the subject's body weight, abilities and preferences, development of a training programme with increasing intensity and volume of physical activity.
Measurements:
Anthropometry: Body weight and body height are determined with a digital scale (Mensor WE150, Poland), with the child wearing an underwear and standing barefoot. Body height is measured to the nearest 0.001 m, and body weight to the nearest 0.1 kg. The scale is calibrated every day. Waist and hip circumferences are measured on a horizontal plane by an Ergonomic Circumference Measuring Tape (model 201; Seca GmbH & Co, KG, Hamburg, Germany).
Blood pressure measurement: Arterial blood pressure is determined oscillometrically (Omron) on the left arm, with a cuff of an adequate size placed at the level of the heart, in the child seated with uncrossed legs, following at least a 5-min rest in the seated position. The width of the inflatable cuff corresponds to at least 40% of arm circumference. Three separate measurements of blood pressure are taken and averaged [42].
Kasch pulse recovery step test: The participants are subjected to a 3-minute Kasch pulse recovery (KPR) step test [43,44]. The test consists of climbing a 0.305 m step at a rate of 24 steps-up/-down per minute. The rate of climbing is defined by a metronome set at 96 beats (signals) per minute. Heart rate (HR) is monitored continuously with "Polar" (Finland) electronic analyser for 3 minutes of the exercise (step-test) and during 1 minute and 5 seconds of recovery in a seated position. Only post-exercise HR recorded within one minute, starting 5 seconds after completing the test, is subjected to analysis. All HR characteristics are recorded during restitution in a seated position (subjects are instructed to sit still, breath normally and not involve in a conversation). An arithmetic mean calculated from these values (HRmean post-ex) is subjected to further analyses.
Dietetic assessment: Dietary records from three consecutive days (2 weekdays + 1 day of a weekend), collected prior to enrolment and at the end of the intervention are analysed, and dietary intakes of calcium and vitamin D are calculated with Dieta 5.0 software (Institute of Food and Nutrition, Warsaw).
Pubertal status is determined on based on the results of physical examination and expressed using the Tanner stage.
DXA: Total body bone mineral content (TBBMC), total body bone mineral density (TBBMD), lean body mass (LBM), fat mass (FT) (Hologic Discovery Wi)
Laboratory parameters:
Complete blood count Lipid profile determined with an enzymatic method Oral glucose tolerance test (OGTT) with glucose concentration determined with hexokinase method Concentration of insulin determined by means of an immunochemiluminescence assay Concentration of creatinine ALT, TSH, fT4, PTH, Ca, P
Visit 1 (enrolment):
medical history, physical examination
interpretation of laboratory findings (tests conducted during screening + concentration of vitamin D),
anthropometric evaluation and analysis of body composition (bioimpedance method)
consultation with a dietician, psychologist and specialist in physical activity, and defining detailed protocol of the intervention
Kasch Pulse Recovery Test
Visit 2 (3 months)
medical history, physical examination
anthropometric evaluation and analysis of body composition (bioimpedance method) consultation with a dietician, psychologist and specialist in physical activity, and defining detailed protocol of the intervention. Within a week prior to Visit II - obtaining blood (ca. 5 ml) for laboratory testing (complete blood count, lipid profile, hs-CRP, OGTT, insulin, TSH, fT4).
consultation with a dietician, psychologist and specialist in physical activity, and defining detailed protocol of the intervention
Visit 3 (6 months)
medical history, physical examination
interpretation of laboratory findings
anthropometric evaluation and analysis of body composition (bioimpedance method)
consultation with a dietician, psychologist and specialist in physical activity, and defining detailed protocol of the intervention
obtaining blood for laboratory testing
termination of active compound/placebo administration
Visit 4 (12 months)
medical history, physical examination
anthropometric evaluation and analysis of body composition (bioimpedance method)
consultation with a dietician, psychologist and specialist in physical activity, and defining detailed protocol of the intervention
The aim of the programme is to reduce baseline body weight of participating children by at least 5% .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obesity, Childhood, Health Program, Body Weight Changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single multidisciplinary intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Other
Arm Description
multidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer
Intervention Type
Behavioral
Intervention Name(s)
multidisciplinary behavioral intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
body mass change
Description
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
Time Frame
12 months from begining of intervention
Secondary Outcome Measure Information:
Title
body fat reduction
Description
Number (percentage) of participants with change of body fat by at least 5%
Time Frame
12 months from begining of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children living in Gdansk (for screening phase)
children with BMI above 85 percentile (for intervention phase)
consent of parent/ caregivers
Exclusion Criteria:
confirmed congenital or metabolic diseases connected with obesity risk
lack of consent of parent/ caregivers
Facility Information:
Facility Name
University Clinical Center
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Brzezinski, PhD
Phone
501762172
Ext
+48
Email
brzezinski@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Paulina Metelska, PhD
Phone
603814314
Ext
+48
Email
pmetelska@uck.gda.pl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
anyone contacting the programme with be assessed and data will be given to researchers/public authorities
Links:
URL
https://doi.org/10.1016/j.appet.2014.01.029
Description
protocol abd primary results
Learn more about this trial
Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health"
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