Programme for Intervention in Paediatric Obesity
- Conditions
- Obesity, Childhood
- Interventions
- Other: Intervention group for the treatment of childhood obesity
- Registration Number
- NCT06457412
- Lead Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Brief Summary
The PinPo program aims to carry out a comprehensive intervention for children aged 6 to 12 years with childhood obesity (with a BMI greater than the 99th percentile), fostering motivation and encouraging changes toward healthy lifestyle habits to achieve greater adherence and improved health. The program comprises 9 educational sessions designed by specialized professionals from various disciplines (pediatrics, psychology, nursing, nutrition), for a group of 10 children and another group of 10 family members and/or caregivers. These sessions are conducted in a hospital setting every 15 days, each lasting 90 minutes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Children between 6 and 12 years old, with a BMI greater than the 99th percentile according to Cole criteria (2004).
- Children < 6, or > 12 years.
- Children with chronic diseases or following a therapeutic diet.
- Children with intervention in other centers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group Intervention group for the treatment of childhood obesity Intervention group for the treatment of childhood obesity
- Primary Outcome Measures
Name Time Method Dietary intake 4 months The daily energy intake will be estimated using data from three internationally validated questionnaires: the adapted Consumption Frequency Questionnaire (CFC), the NHANES Food Questionnaire, and the Kidmed Test. The unit of measurement is kilocalories.
Diet composition 4 months The composition of the diet by macronutrients and micronutrients will be estimated using data from three internationally validated questionnaires: the adapted Consumption Frequency Questionnaire (CFC), the NHANES Food Questionnaire, and the Kidmed Test. The unit of measurement is grams.
- Secondary Outcome Measures
Name Time Method Hematological analysis: Lymphocytes 4 months Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Hematological analysis: Basophiles 4 months Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Hematological analysis: Platelets 4 months Platelets count is measured in 10e03 units per microliter on an individual basis.
Hematological analysis: Mean platelet volume 4 months Mean platelet volume is measured in femtoliters on an individual basis.
Biochemical analysis: Carbohydrates 4 months Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed Carbohydrates are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Polyunsaturated fatty acids 4 months Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin C 4 months Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Retinol 4 months Retinol is measured in micrograms on an individual basis. Analysis performed in plasma.
Hematological analysis: Mean corpuscular hemoglobin 4 months Mean corpuscular hemoglobine is measured in picograms on an individual basis.
Hematological analysis: Mean corpuscular hemoglobin concentration 4 months Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.
Hematological analysis: Neutrophils 4 months Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Biochemical analysis: Bilirubin 4 months Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma
Biochemical analysis: Creatinine 4 months Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Urate 4 months Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Total protein 4 months Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Alanine aminotransferase 4 months Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Fiber 4 months Fibers are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Monounsaturated fatty acids 4 months Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin B1 4 months Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma
Biochemical analysis: Vitamin B3 4 months Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin B12 4 months Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma.
Biochemical analysis: Water 4 months Water is measured in grams on an individual basis. Analysis performed in plasma.
Self-esteem 4 months Self-esteem will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.
Hematological analysis: Erythrocytes 4 months Erythrocytes count is measured in 10e06 units per microliter on an individual basis.
Biochemical analysis: Urea 4 months Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Aspartate aminotransferase 4 months Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin B2 4 months Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin B6 4 months Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin B9 4 months Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin E 4 months Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma.
Fecal microbiome: DNA 4 months Samples will be homogenized in a Stomacher-400 blender. Subsequently, a QIAamp DNA Stool Mini Kit (QIAGEN, Barcelona, Spain) will be used for the DNA extraction as indicated by the manufacturer with the exception of the incubation at 70 °C, since the samples will be mixed with the lysis buffer and incubated at a temperature of 95 °C to ensure that both Gram-positive and Gram-negative bacteria are lysed. The quantification of the DNA will be conducted with a NanoDrop ND1000 spectrophotometer (Thermo Fisher Scientific, DE, USA) and the DNA yield will be calculated by measuring absorbance ratios spectrophotometrically, including A260/230 nm for salt and phenol contamination and A260/280 nm for protein contamination. The unit of measurement is percentage of abundance.
Biochemical analysis: Vitamin A 4 months Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma.
Biochemical analysis: Vitamin D 4 months Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma.
Biochemical analysis: Carotenes 4 months Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma.
Biochemical analysis: Glucose 4 months Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Insulin 4 months Insulin is measured both in micro international units per liter and in picograms per milliliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Adiponectin 4 months Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Energy 4 months Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed Energy is determined in kilocalories on an individual basis. Analysis performed in plasma.
Biochemical analysis: Sugars 4 months Sugars are measured in grams on an individual basis. Analysis performed in plasma.Carbohydrates are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Magnesium 4 months Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Phosphorus 4 months Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Iron 4 months Iron is measured in milligrams on an individual basis. Analysis performed in plasma.
Height 4 months Height in centimeters is measured with the SECA 213 precision measuring instrument.
Confidence 4 months Confidence will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.
Hematological analysis: Hematocrite 4 months Hematocrite levels are determined in percentage on an individual basis.
Physical activity and sedentary behavior 4 months Physical activity and sedentary behavior will be assessed in terms of time using an ad hoc questionnaire. The unit of measurement is minutes.
Screen Time 4 months Screen time (including television, computers, cell phones, video games, and consoles) will be assessed in terms of time using an ad hoc questionnaire. The unit of measurement is minutes of screen display.
Body mass index 4 months Body mass index in kilograms per square meter is calculated.
Hematological analysis: Mean corpuscular volume 4 months Mean corpuscular volume is measured in femtoliters on an individual basis.
Hematological analysis: Red cell blood distribution width 4 months Red cell blood distribution width is determined in percentage on an individual basis.
Hematological analysis: White blood cells 4 months White blood cells count is measured in 10e03 units per microliter on an individual basis.
Waist circumference 4 months Waist circumference in centimeters is measured with a CESCORF measuring tape
Emotional Regulation 4 months Emotional regulation will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.
Hematological analysis: Hemoglobine 4 months Hemoglobin levels are determined in grams per deciliter on an individual basis.
Biochemical analysis: High density lipoproteins 4 months High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Calcium 4 months Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Potassium 4 months Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma.
Weight 4 months Weight in grams is measured by the precision weighing scale model Tanita 780PMA
Hematological analysis: Monocytes 4 months Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Hematological analysis: Eosinophils 4 months Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Biochemical analysis: Gamma-glutamyl transferase 4 months Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Alkaline phosphatase 4 months Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Low density lipoproteins 4 months Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Apolipoprotein B 4 months Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Non-HDL cholesterol 4 months Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Apolipoprotein A1 4 months Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Total cholesterol 4 months Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Insulin resistance 4 months The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.
Biochemical analysis: Polysaccharides 4 months Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Total fat 4 months Total fat is measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Sodium 4 months Sodium is measured in millimoles per liter, in milliequivalents per liter and in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Saturated fatty acids 4 months Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Biochemical analysis: Zinc 4 months Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.
Biochemical analysis: C-reactive protein 4 months C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Biochemical analysis: Tumor necrosis factor alpha 4 months Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma.
Trial Locations
- Locations (1)
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain