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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06457412
Other study ID # PinPo
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2032

Study information

Verified date May 2024
Source Maimónides Biomedical Research Institute of Córdoba
Contact Mercedes Gil-Campos, MD, Phd
Phone +34957736467
Email mercedes_gil_campos@yahoo.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date March 1, 2032
Est. primary completion date March 1, 2032
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Children between 6 and 12 years old, with a BMI greater than the 99th percentile according to Cole criteria (2004). Exclusion Criteria: - Children < 6, or > 12 years. - Children with chronic diseases or following a therapeutic diet. - Children with intervention in other centers.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intervention group for the treatment of childhood obesity
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 to improve health. The program comprises 9 educational sessions designed by specialized professionals (code of Spanish register: 2007144741729) to be conducted in a health center. The sessions will be held every 15 days, with a duration of 90 minutes for a group of 10 children and another group of 10 family members and/or caregivers. Professionals from different disciplines (paediatricians, psychologists, nurses and nutritionists), will meet with groups of pediatric patients and in another group with their family members or primary caregivers.

Locations

Country Name City State
Spain Hospital Universitario Reina Sofia Córdoba

Sponsors (3)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba Hospital Universitario Reina Sofia de Cordoba, Universidad de Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary Height Height in centimeters is measured with the SECA 213 precision measuring instrument. 4 months
Secondary Weight Weight in grams is measured by the precision weighing scale model Tanita 780PMA 4 months
Secondary Body mass index Body mass index in kilograms per square meter is calculated. 4 months
Secondary Waist circumference Waist circumference in centimeters is measured with a CESCORF measuring tape 4 months
Secondary Self-esteem Self-esteem will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score. 4 months
Secondary Confidence Confidence will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score. 4 months
Secondary Emotional Regulation Emotional regulation will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score. 4 months
Secondary Hematological analysis: Hemoglobine Hemoglobin levels are determined in grams per deciliter on an individual basis. 4 months
Secondary Hematological analysis: Hematocrite Hematocrite levels are determined in percentage on an individual basis. 4 months
Secondary Hematological analysis: Erythrocytes Erythrocytes count is measured in 10e06 units per microliter on an individual basis. 4 months
Secondary Hematological analysis: Mean corpuscular volume Mean corpuscular volume is measured in femtoliters on an individual basis. 4 months
Secondary Hematological analysis: Mean corpuscular hemoglobin Mean corpuscular hemoglobine is measured in picograms on an individual basis. 4 months
Secondary Hematological analysis: Mean corpuscular hemoglobin concentration Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis. 4 months
Secondary Hematological analysis: Red cell blood distribution width Red cell blood distribution width is determined in percentage on an individual basis. 4 months
Secondary Hematological analysis: White blood cells White blood cells count is measured in 10e03 units per microliter on an individual basis. 4 months
Secondary Hematological analysis: Neutrophils Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis. 4 months
Secondary Hematological analysis: Lymphocytes Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis. 4 months
Secondary Hematological analysis: Monocytes Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis. 4 months
Secondary Hematological analysis: Eosinophils Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis. 4 months
Secondary Hematological analysis: Basophiles Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis. 4 months
Secondary Hematological analysis: Platelets Platelets count is measured in 10e03 units per microliter on an individual basis. 4 months
Secondary Hematological analysis: Mean platelet volume Mean platelet volume is measured in femtoliters on an individual basis. 4 months
Secondary Biochemical analysis: Glucose Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Bilirubin Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma 4 months
Secondary Biochemical analysis: Creatinine Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Urate Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Urea Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary Biochemical analysis: Aspartate aminotransferase Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Alanine aminotransferase Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary Biochemical analysis: Alkaline phosphatase Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Total cholesterol Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary 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
Secondary 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
Secondary Biochemical analysis: Apolipoprotein A1 Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Apolipoprotein B Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Calcium Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Potassium Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary Biochemical analysis: Phosphorus Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Iron Iron is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Magnesium Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Zinc Zinc is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary Biochemical analysis: Insulin resistance The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance. 4 months
Secondary Biochemical analysis: C-reactive protein C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary Biochemical analysis: Adiponectin Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
Secondary 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
Secondary 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
Secondary Biochemical analysis: Fiber Fibers are measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Polysaccharides Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Total fat Total fat is measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Saturated fatty acids Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Monounsaturated fatty acids Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Polyunsaturated fatty acids Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin B1 Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma 4 months
Secondary Biochemical analysis: Vitamin B2 Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin B3 Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin B6 Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin B9 Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin B12 Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin C Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin A Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin D Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Vitamin E Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Carotenes Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Retinol Retinol is measured in micrograms on an individual basis. Analysis performed in plasma. 4 months
Secondary Biochemical analysis: Water Water is measured in grams on an individual basis. Analysis performed in plasma. 4 months
Secondary 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
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