Programme for Intervention in Paediatric Obesity
NCT Number: NCT06457412
Acronym: PinPo
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obesity, Childhood
Interventions: OTHER: Intervention group for the treatment of childhood obesity
Sponsor: Maimónides Biomedical Research Institute of Córdoba
Collaborators: Hospital Universitario Reina Sofia de Cordoba|Universidad de Córdoba
Sex: ALL
Age: CHILD
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-03-01
Completion Date: 2032-03-01
Locations: Hospital Universitario Reina Sofia, Córdoba, Spain

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.

Primary Outcome Measures: Dietary intake, 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., 4 months|Diet composition, 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., 4 months
Secondary Outcome Measures: Physical activity and sedentary behavior, Physical activity and sedentary behavior will be assessed in terms of time using an ad hoc questionnaire. The unit of measurement is minutes., 4 months|Screen Time, 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., 4 months|Height, Height in centimeters is measured with the SECA 213 precision measuring instrument., 4 months|Weight, Weight in grams is measured by the precision weighing scale model Tanita 780PMA, 4 months|Body mass index, Body mass index in kilograms per square meter is calculated., 4 months|Waist circumference, Waist circumference in centimeters is measured with a CESCORF measuring tape, 4 months|Self-esteem, Self-esteem will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score., 4 months|Confidence, Confidence will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score., 4 months|Emotional Regulation, Emotional regulation will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score., 4 months|Hematological analysis: Hemoglobine, Hemoglobin levels are determined in grams per deciliter on an individual basis., 4 months|Hematological analysis: Hematocrite, Hematocrite levels are determined in percentage on an individual basis., 4 months|Hematological analysis: Erythrocytes, Erythrocytes count is measured in 10e06 units per microliter on an individual basis., 4 months|Hematological analysis: Mean corpuscular volume, Mean corpuscular volume is measured in femtoliters on an individual basis., 4 months|Hematological analysis: Mean corpuscular hemoglobin, Mean corpuscular hemoglobine is measured in picograms on an individual basis., 4 months|Hematological analysis: Mean corpuscular hemoglobin concentration, Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis., 4 months|Hematological analysis: Red cell blood distribution width, Red cell blood distribution width is determined in percentage on an individual basis., 4 months|Hematological analysis: White blood cells, White blood cells count is measured in 10e03 units per microliter on an individual basis., 4 months|Hematological analysis: Neutrophils, Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis., 4 months|Hematological analysis: Lymphocytes, Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis., 4 months|Hematological analysis: Monocytes, Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis., 4 months|Hematological analysis: Eosinophils, Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis., 4 months|Hematological analysis: Basophiles, Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis., 4 months|Hematological analysis: Platelets, Platelets count is measured in 10e03 units per microliter on an individual basis., 4 months|Hematological analysis: Mean platelet volume, Mean platelet volume is measured in femtoliters on an individual basis., 4 months|Biochemical analysis: Glucose, Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Bilirubin, Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma, 4 months|Biochemical analysis: Creatinine, Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Urate, Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Urea, Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Total protein, Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Aspartate aminotransferase, Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Alanine aminotransferase, Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Gamma-glutamyl transferase, Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Alkaline phosphatase, Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Total cholesterol, Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: High density lipoproteins, High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Non-HDL cholesterol, Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Low density lipoproteins, Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Apolipoprotein A1, Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Apolipoprotein B, Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Calcium, Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Potassium, Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Sodium, Sodium is measured in millimoles per liter, in milliequivalents per liter and in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Phosphorus, Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Iron, Iron is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Magnesium, Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Zinc, Zinc is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Insulin, Insulin is measured both in micro international units per liter and in picograms per milliliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Insulin resistance, The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance., 4 months|Biochemical analysis: C-reactive protein, C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Tumor necrosis factor alpha, Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Adiponectin, Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Energy, 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., 4 months|Biochemical analysis: Carbohydrates, 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., 4 months|Biochemical analysis: Sugars, 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., 4 months|Biochemical analysis: Fiber, Fibers are measured in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Polysaccharides, Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Total fat, Total fat is measured in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Saturated fatty acids, Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Monounsaturated fatty acids, Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Polyunsaturated fatty acids, Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin B1, Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma, 4 months|Biochemical analysis: Vitamin B2, Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin B3, Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin B6, Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin B9, Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin B12, Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin C, Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin A, Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin D, Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Vitamin E, Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Carotenes, Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Retinol, Retinol is measured in micrograms on an individual basis. Analysis performed in plasma., 4 months|Biochemical analysis: Water, Water is measured in grams on an individual basis. Analysis performed in plasma., 4 months|Fecal microbiome: DNA, 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., 4 months