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Clinical Trials/NCT06457412
NCT06457412
Recruiting
Not Applicable

Programme for Intervention in Paediatric Obesity

Maimónides Biomedical Research Institute of Córdoba1 site in 1 country200 target enrollmentMarch 1, 2022
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ConditionsObesity, Childhood

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Childhood
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Enrollment
200
Locations
1
Primary Endpoint
Dietary intake
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
March 1, 2032
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Maimónides Biomedical Research Institute of Córdoba
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Dietary intake

Time Frame: 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

Time Frame: 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 Outcomes

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

Study Sites (1)

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