Programme for Intervention in Paediatric Obesity (PinPo)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood
• Intervention / Treatment: Other: Intervention group for the treatment of childhood obesity

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mercedes Gil-Campos, MD, Phd; Phone Number: +34957736467; Email: mercedes_gil_campos@yahoo.es

Study Locations

• Spain
  • Córdoba, Spain
    • Recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Mercedes Gil-Campos, PhD, MD; Email: mercedes_gil_campos@yahoo.es
    • Principal Investigator: Mercedes Gil-Campos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 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

Experimental: Intervention Group; Intervention group for the treatment of childhood obesity

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Hospital Universitario Reina Sofia de Cordoba; Universidad de Córdoba

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Childhood; Grupal intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: PinPo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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