Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04143074 |
Other study ID # |
NKBBN/228/2012 |
Secondary ID |
NKBBN/228/2012 |
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2011 |
Est. completion date |
August 31, 2021 |
Study information
Verified date |
October 2019 |
Source |
University Clinical Centre, Gdansk |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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:
1. 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.
2. 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% .