Clinical trial NCT04143074: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Obesity, Childhood
Health Program
Body Weight Changes
Lead sponsor: University Clinical Centre, Gdansk
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 6000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single multidisciplinary intervention
Primary purpose: TREATMENT

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:

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% .

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

Primary outcomes:
measure: body mass change
timeFrame: 12 months from begining of intervention
Secondary outcomes:
measure: body fat reduction
timeFrame: 12 months from begining of intervention
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: University Clinical Center
Study officials:
References: