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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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:
- 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% .
- Conditions
- Obesity, Obesity, Childhood, Health Program, Body Weight Changes
- 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 group | Role | What they receive |
|---|---|---|
| intervention | Other | multidisciplinary 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.
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)
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.
- First posted29 Oct 2019
- Study start1 Apr 2011
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Michał Brzeziński
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michał Brzeziński, University Clinical Centre, Gdansk
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Population Activities in the Field of Prevention, Early Identification and Treatment of Overweight and Obesity in Gdansk Children and Youth Population"
- ClinicalTrials.gov ID
- NCT04143074
- Acronym / sponsor ID
- NKBBN/228/2012
- Conditions
- Obesity, Obesity, Childhood, Health Program, Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Michał BrzezińskiUniversity, hospital or other
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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% .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single multidisciplinary intervention
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Behavioral: multidisciplinary behavioral interventionmultidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children living in Gdansk (for screening phase)
- children with BMI above 85 percentile (for intervention phase)
- consent of parent/ caregivers
Key exclusion criteria (2 listed)
- confirmed congenital or metabolic diseases connected with obesity risk
- lack of consent of parent/ caregivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary behavioral interventionbehavioral 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). | Behavioural | intervention |
Primary outcome
body mass change
Time frame: 12 months from begining of intervention
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
1 secondary outcome
body fat reduction
Time frame: 12 months from begining of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- protocol abd primary resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. anyone contacting the programme with be assessed and data will be given to researchers/public authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.