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"

"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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Body Weight Changes; Obesity, Childhood; Health Program
• Intervention / Treatment: Behavioral: multidisciplinary behavioral intervention

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% .

• Study Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-952
    • Recruiting
    • University Clinical Center
    • Contact: Michal Brzezinski, PhD; Phone Number: +48 501762172; Email: brzezinski@gumed.edu.pl
    • Contact: Paulina Metelska, PhD; Phone Number: +48 603814314; Email: pmetelska@uck.gda.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: intervention; multidisciplinary intervention arm - behavioral intervention by physician, dietician, psychologist and physical activity trainer

Behavioral: multidisciplinary behavioral intervention; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
body fat reduction	Number (percentage) of participants with change of body fat by at least 5%	12 months from begining of intervention

Collaborators and Investigators

• Sponsor: Michał Brzeziński

Publications and helpful links

Helpful Links

• protocol abd primary results

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Obesity; Pediatric Obesity; Body Weight; Body Weight Changes
• Other Study ID Numbers: NKBBN/228/2012 (Other Identifier: Independent Bioethics Commission for Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: anyone contacting the programme with be assessed and data will be given to researchers/public authorities

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No