Clinical trial NCT06457412: Programme for Intervention in Paediatric Obesity
Official title: Programme for Intervention in Paediatric Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: Obesity
Childhood
Grupal intervention
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
name: Universidad de Córdoba
First posted: 2024-06-13
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dietary intake
timeFrame: 4 months
measure: Diet composition
timeFrame: 4 months
Secondary outcomes:
measure: Physical activity and sedentary behavior
timeFrame: 4 months
measure: Screen Time
timeFrame: 4 months
measure: Height
timeFrame: 4 months
measure: Weight
timeFrame: 4 months
measure: Body mass index
timeFrame: 4 months
measure: Waist circumference
timeFrame: 4 months
measure: Self-esteem
timeFrame: 4 months
measure: Confidence
timeFrame: 4 months
measure: Emotional Regulation
timeFrame: 4 months
measure: Hematological analysis: Hemoglobine
timeFrame: 4 months
measure: Hematological analysis: Hematocrite
timeFrame: 4 months
measure: Hematological analysis: Erythrocytes
timeFrame: 4 months
measure: Hematological analysis: Mean corpuscular volume
timeFrame: 4 months
measure: Hematological analysis: Mean corpuscular hemoglobin
timeFrame: 4 months
measure: Hematological analysis: Mean corpuscular hemoglobin concentration
timeFrame: 4 months
measure: Hematological analysis: Red cell blood distribution width
timeFrame: 4 months
measure: Hematological analysis: White blood cells
timeFrame: 4 months
measure: Hematological analysis: Neutrophils
timeFrame: 4 months
measure: Hematological analysis: Lymphocytes
timeFrame: 4 months
measure: Hematological analysis: Monocytes
timeFrame: 4 months
measure: Hematological analysis: Eosinophils
timeFrame: 4 months
measure: Hematological analysis: Basophiles
timeFrame: 4 months
measure: Hematological analysis: Platelets
timeFrame: 4 months
measure: Hematological analysis: Mean platelet volume
timeFrame: 4 months
measure: Biochemical analysis: Glucose
timeFrame: 4 months
measure: Biochemical analysis: Bilirubin
timeFrame: 4 months
measure: Biochemical analysis: Creatinine
timeFrame: 4 months
measure: Biochemical analysis: Urate
timeFrame: 4 months
measure: Biochemical analysis: Urea
timeFrame: 4 months
measure: Biochemical analysis: Total protein
timeFrame: 4 months
measure: Biochemical analysis: Aspartate aminotransferase
timeFrame: 4 months
measure: Biochemical analysis: Alanine aminotransferase
timeFrame: 4 months
measure: Biochemical analysis: Gamma-glutamyl transferase
timeFrame: 4 months
measure: Biochemical analysis: Alkaline phosphatase
timeFrame: 4 months
measure: Biochemical analysis: Total cholesterol
timeFrame: 4 months
measure: Biochemical analysis: High density lipoproteins
timeFrame: 4 months
measure: Biochemical analysis: Non-HDL cholesterol
timeFrame: 4 months
measure: Biochemical analysis: Low density lipoproteins
timeFrame: 4 months
measure: Biochemical analysis: Apolipoprotein A1
timeFrame: 4 months
measure: Biochemical analysis: Apolipoprotein B
timeFrame: 4 months
measure: Biochemical analysis: Calcium
timeFrame: 4 months
measure: Biochemical analysis: Potassium
timeFrame: 4 months
measure: Biochemical analysis: Sodium
timeFrame: 4 months
measure: Biochemical analysis: Phosphorus
timeFrame: 4 months
measure: Biochemical analysis: Iron
timeFrame: 4 months
measure: Biochemical analysis: Magnesium
timeFrame: 4 months
measure: Biochemical analysis: Zinc
timeFrame: 4 months
measure: Biochemical analysis: Insulin
timeFrame: 4 months
measure: Biochemical analysis: Insulin resistance
timeFrame: 4 months
measure: Biochemical analysis: C-reactive protein
timeFrame: 4 months
measure: Biochemical analysis: Tumor necrosis factor alpha
timeFrame: 4 months
measure: Biochemical analysis: Adiponectin
timeFrame: 4 months
measure: Biochemical analysis: Energy
timeFrame: 4 months
measure: Biochemical analysis: Carbohydrates
timeFrame: 4 months
measure: Biochemical analysis: Sugars
timeFrame: 4 months
measure: Biochemical analysis: Fiber
timeFrame: 4 months
measure: Biochemical analysis: Polysaccharides
timeFrame: 4 months
measure: Biochemical analysis: Total fat
timeFrame: 4 months
measure: Biochemical analysis: Saturated fatty acids
timeFrame: 4 months
measure: Biochemical analysis: Monounsaturated fatty acids
timeFrame: 4 months
measure: Biochemical analysis: Polyunsaturated fatty acids
timeFrame: 4 months
measure: Biochemical analysis: Vitamin B1
timeFrame: 4 months
measure: Biochemical analysis: Vitamin B2
timeFrame: 4 months
measure: Biochemical analysis: Vitamin B3
timeFrame: 4 months
measure: Biochemical analysis: Vitamin B6
timeFrame: 4 months
measure: Biochemical analysis: Vitamin B9
timeFrame: 4 months
measure: Biochemical analysis: Vitamin B12
timeFrame: 4 months
measure: Biochemical analysis: Vitamin C
timeFrame: 4 months
measure: Biochemical analysis: Vitamin A
timeFrame: 4 months
measure: Biochemical analysis: Vitamin D
timeFrame: 4 months
measure: Biochemical analysis: Vitamin E
timeFrame: 4 months
measure: Biochemical analysis: Carotenes
timeFrame: 4 months
measure: Biochemical analysis: Retinol
timeFrame: 4 months
measure: Biochemical analysis: Water
timeFrame: 4 months
measure: Fecal microbiome: DNA
timeFrame: 4 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
Study officials:
References: