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ObesityNCT04143074

Community Based Obesity Prevention and Treatment Programme "6-10-14 for Health"

A study testing multidisciplinary behavioral intervention in people with Obesity and Obesity, Childhood, run by Michał Brzeziński at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Obesity, Childhood, Health Program
What is being tested?
multidisciplinary behavioral intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,000 participants
Where
1 sitePoland
Study dates
1 Apr 2011to 31 Aug 2021
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 6 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • children living in Gdansk (for screening phase)
  • children with BMI above 85 percentile (for intervention phase)
  • consent of parent/ caregivers

Who cannot join

  • confirmed congenital or metabolic diseases connected with obesity risk
  • lack of consent of parent/ caregivers

Trial locations and contacts

1 site in 1 country.

Poland1 site, 1 recruiting
  • University Clinical Center

    Gdansk, 80-952

    Michal Brzezinski, PhD, 501762172 ext. +48, brzezinski@gumed.edu.pl

    Paulina Metelska, PhD, 603814314 ext. +48, pmetelska@uck.gda.pl

    Recruiting

Other trials in Poland

About this study

Official title: "Population Activities in the Field of Prevention, Early Identification and Treatment of Overweight and Obesity in Gdansk Children and Youth Population"

"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.

Read the 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:

  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% .

Being tested
multidisciplinary behavioral intervention
Medical subject headings
Obesity, Pediatric Obesity, Body Weight Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multidisciplinary behavioral interventionBehavioural

    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).

Study groups in NCT04143074
Study groupRoleWhat they receive
interventionOthermultidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer
Receives: Behavioral: multidisciplinary behavioral intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months from begining of intervention

Secondary outcomes (1)
  1. body fat reduction

    Number (percentage) of participants with change of body fat by at least 5%

    Measured: 12 months from begining of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start1 Apr 2011
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
single multidisciplinary intervention
Masking
None (open label)
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143074
Sponsor's protocol ID
NKBBN/228/2012
Other IDs
NKBBN/228/2012
Status last verified
Oct 2019
First submitted
24 Oct 2019
Last updated
29 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: anyone contacting the programme with be assessed and data will be given to researchers/public authorities

Questions about this trial

What is this clinical trial studying?

A study testing multidisciplinary behavioral intervention in people with Obesity and Obesity, Childhood, run by Michał Brzeziński at 1 site in Poland.

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 3 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 29 Oct 2019. 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 Poland. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

body mass change (time frame: 12 months from begining of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Oct 2019.

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