Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06457412

Programme for Intervention in Paediatric Obesity

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location status: Recruiting

Location contact

Mercedes Gil-Campos

PRINCIPAL_INVESTIGATOR

Mercedes Gil-Campos, PhD, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention group for the treatment of childhood obesity

Other

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.

Primary outcomes

  1. 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.

  2. 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

  1. Physical activity and sedentary behavior

    Time frame: 4 months

    Physical activity and sedentary behavior will be assessed in terms of time using an ad hoc questionnaire. The unit of measurement is minutes.

  2. Screen Time

    Time frame: 4 months

    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.

  3. Height

    Time frame: 4 months

    Height in centimeters is measured with the SECA 213 precision measuring instrument.

  4. Weight

    Time frame: 4 months

    Weight in grams is measured by the precision weighing scale model Tanita 780PMA

  5. Body mass index

    Time frame: 4 months

    Body mass index in kilograms per square meter is calculated.

  6. Waist circumference

    Time frame: 4 months

    Waist circumference in centimeters is measured with a CESCORF measuring tape

  7. Self-esteem

    Time frame: 4 months

    Self-esteem will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.

  8. Confidence

    Time frame: 4 months

    Confidence will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.

  9. Emotional Regulation

    Time frame: 4 months

    Emotional regulation will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.

  10. Hematological analysis: Hemoglobine

    Time frame: 4 months

    Hemoglobin levels are determined in grams per deciliter on an individual basis.

  11. Hematological analysis: Hematocrite

    Time frame: 4 months

    Hematocrite levels are determined in percentage on an individual basis.

  12. Hematological analysis: Erythrocytes

    Time frame: 4 months

    Erythrocytes count is measured in 10e06 units per microliter on an individual basis.

  13. Hematological analysis: Mean corpuscular volume

    Time frame: 4 months

    Mean corpuscular volume is measured in femtoliters on an individual basis.

  14. Hematological analysis: Mean corpuscular hemoglobin

    Time frame: 4 months

    Mean corpuscular hemoglobine is measured in picograms on an individual basis.

  15. Hematological analysis: Mean corpuscular hemoglobin concentration

    Time frame: 4 months

    Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.

  16. Hematological analysis: Red cell blood distribution width

    Time frame: 4 months

    Red cell blood distribution width is determined in percentage on an individual basis.

  17. Hematological analysis: White blood cells

    Time frame: 4 months

    White blood cells count is measured in 10e03 units per microliter on an individual basis.

  18. Hematological analysis: Neutrophils

    Time frame: 4 months

    Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.

  19. Hematological analysis: Lymphocytes

    Time frame: 4 months

    Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.

  20. Hematological analysis: Monocytes

    Time frame: 4 months

    Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.

  21. Hematological analysis: Eosinophils

    Time frame: 4 months

    Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.

  22. Hematological analysis: Basophiles

    Time frame: 4 months

    Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.

  23. Hematological analysis: Platelets

    Time frame: 4 months

    Platelets count is measured in 10e03 units per microliter on an individual basis.

  24. Hematological analysis: Mean platelet volume

    Time frame: 4 months

    Mean platelet volume is measured in femtoliters on an individual basis.

  25. Biochemical analysis: Glucose

    Time frame: 4 months

    Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  26. Biochemical analysis: Bilirubin

    Time frame: 4 months

    Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma

  27. Biochemical analysis: Creatinine

    Time frame: 4 months

    Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  28. Biochemical analysis: Urate

    Time frame: 4 months

    Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  29. Biochemical analysis: Urea

    Time frame: 4 months

    Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  30. Biochemical analysis: Total protein

    Time frame: 4 months

    Total protein is measured both in grams per deciliter and in grams on an individual basis. Analysis performed in plasma.

  31. Biochemical analysis: Aspartate aminotransferase

    Time frame: 4 months

    Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.

  32. Biochemical analysis: Alanine aminotransferase

    Time frame: 4 months

    Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.

  33. Biochemical analysis: Gamma-glutamyl transferase

    Time frame: 4 months

    Gamma-glutamyl transferase is measured in international units per liter on an individual basis. Analysis performed in plasma.

  34. Biochemical analysis: Alkaline phosphatase

    Time frame: 4 months

    Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.

  35. Biochemical analysis: Total cholesterol

    Time frame: 4 months

    Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  36. Biochemical analysis: High density lipoproteins

    Time frame: 4 months

    High density lipoproteins (HDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  37. Biochemical analysis: Non-HDL cholesterol

    Time frame: 4 months

    Non-HDL cholesterol levels are calculated in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  38. Biochemical analysis: Low density lipoproteins

    Time frame: 4 months

    Low density lipoproteins (LDL) are measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  39. Biochemical analysis: Apolipoprotein A1

    Time frame: 4 months

    Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  40. Biochemical analysis: Apolipoprotein B

    Time frame: 4 months

    Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  41. Biochemical analysis: Calcium

    Time frame: 4 months

    Calcium is measured both in milligrams per deciliter and in milligrams on an individual basis. Analysis performed in plasma.

  42. Biochemical analysis: Potassium

    Time frame: 4 months

    Potassium is measured both in millimoles per liter and in milligrams on an individual basis. Analysis performed in plasma.

  43. Biochemical analysis: Sodium

    Time frame: 4 months

    Sodium is measured in millimoles per liter, in milliequivalents per liter and in milligrams on an individual basis. Analysis performed in plasma.

  44. Biochemical analysis: Phosphorus

    Time frame: 4 months

    Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.

  45. Biochemical analysis: Iron

    Time frame: 4 months

    Iron is measured in milligrams on an individual basis. Analysis performed in plasma.

  46. Biochemical analysis: Magnesium

    Time frame: 4 months

    Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.

  47. Biochemical analysis: Zinc

    Time frame: 4 months

    Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.

  48. Biochemical analysis: Insulin

    Time frame: 4 months

    Insulin is measured both in micro international units per liter and in picograms per milliliter on an individual basis. Analysis performed in plasma.

  49. Biochemical analysis: Insulin resistance

    Time frame: 4 months

    The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.

  50. Biochemical analysis: C-reactive protein

    Time frame: 4 months

    C-reactive protein is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.

  51. Biochemical analysis: Tumor necrosis factor alpha

    Time frame: 4 months

    Tumor necrosis factor alpha is measured in picograms per deciliter on an individual basis. Analysis performed in plasma.

  52. Biochemical analysis: Adiponectin

    Time frame: 4 months

    Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.

  53. Biochemical analysis: Energy

    Time frame: 4 months

    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.

  54. Biochemical analysis: Carbohydrates

    Time frame: 4 months

    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.

  55. Biochemical analysis: Sugars

    Time frame: 4 months

    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.

  56. Biochemical analysis: Fiber

    Time frame: 4 months

    Fibers are measured in grams on an individual basis. Analysis performed in plasma.

  57. Biochemical analysis: Polysaccharides

    Time frame: 4 months

    Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.

  58. Biochemical analysis: Total fat

    Time frame: 4 months

    Total fat is measured in grams on an individual basis. Analysis performed in plasma.

  59. Biochemical analysis: Saturated fatty acids

    Time frame: 4 months

    Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.

  60. Biochemical analysis: Monounsaturated fatty acids

    Time frame: 4 months

    Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.

  61. Biochemical analysis: Polyunsaturated fatty acids

    Time frame: 4 months

    Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.

  62. Biochemical analysis: Vitamin B1

    Time frame: 4 months

    Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma

  63. Biochemical analysis: Vitamin B2

    Time frame: 4 months

    Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma.

  64. Biochemical analysis: Vitamin B3

    Time frame: 4 months

    Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma.

  65. Biochemical analysis: Vitamin B6

    Time frame: 4 months

    Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma.

  66. Biochemical analysis: Vitamin B9

    Time frame: 4 months

    Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma.

  67. Biochemical analysis: Vitamin B12

    Time frame: 4 months

    Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma.

  68. Biochemical analysis: Vitamin C

    Time frame: 4 months

    Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma.

  69. Biochemical analysis: Vitamin A

    Time frame: 4 months

    Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma.

  70. Biochemical analysis: Vitamin D

    Time frame: 4 months

    Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma.

  71. Biochemical analysis: Vitamin E

    Time frame: 4 months

    Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma.

  72. Biochemical analysis: Carotenes

    Time frame: 4 months

    Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma.

  73. Biochemical analysis: Retinol

    Time frame: 4 months

    Retinol is measured in micrograms on an individual basis. Analysis performed in plasma.

  74. Biochemical analysis: Water

    Time frame: 4 months

    Water is measured in grams on an individual basis. Analysis performed in plasma.

  75. Fecal microbiome: DNA

    Time frame: 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mercedes Gil-Campos, MD, Phd

CONTACT

[email protected]

+34957736467

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • Hospital Universitario Reina Sofia de Cordoba
  • Universidad de Córdoba

Registry information

Acronym: PinPo

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.