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Obesity, ChildhoodPinPoNCT06457412

Programme for Intervention in Paediatric Obesity

A study testing Intervention group for the treatment of childhood obesity in people with Obesity, Childhood, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Obesity, Childhood
What is being tested?
Intervention group for the treatment of childhood obesity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
1 Mar 2022to 1 Mar 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children between 6 and 12 years old, with a BMI greater than the 99th percentile according to Cole criteria (2004).

Who cannot join

  • Children < 6, or > 12 years.
  • Children with chronic diseases or following a therapeutic diet.
  • Children with intervention in other centers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mercedes Gil-Campos, MD, Phd contact

+34957736467

mercedes_gil_campos@yahoo.es

Spain1 site, 1 recruiting

  • Hospital Universitario Reina Sofia

    Córdoba

    Mercedes Gil-Campos, PhD, MD, mercedes_gil_campos@yahoo.es

    Mercedes Gil-Campos

    Recruiting

Other trials in Spain

About this study

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.

Being tested
Intervention group for the treatment of childhood obesity
Keywords
Obesity, Childhood, Grupal intervention
Medical subject headings
Pediatric Obesity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention group for the treatment of childhood obesityOther

    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.

Study groups in NCT06457412
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention group for the treatment of childhood obesity
Receives: Other: Intervention group for the treatment of childhood obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 4 months

Secondary outcomes (75)

  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 4 months

  3. Height

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

    Measured: 4 months

  4. Weight

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

    Measured: 4 months

  5. Body mass index

    Body mass index in kilograms per square meter is calculated.

    Measured: 4 months

  6. Waist circumference

    Waist circumference in centimeters is measured with a CESCORF measuring tape

    Measured: 4 months

  7. Self-esteem

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

    Measured: 4 months

  8. Confidence

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

    Measured: 4 months

  9. Emotional Regulation

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

    Measured: 4 months

  10. Hematological analysis: Hemoglobine

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

    Measured: 4 months

  11. Hematological analysis: Hematocrite

    Hematocrite levels are determined in percentage on an individual basis.

    Measured: 4 months

  12. Hematological analysis: Erythrocytes

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

    Measured: 4 months

  13. Hematological analysis: Mean corpuscular volume

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

    Measured: 4 months

  14. Hematological analysis: Mean corpuscular hemoglobin

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

    Measured: 4 months

  15. Hematological analysis: Mean corpuscular hemoglobin concentration

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

    Measured: 4 months

  16. Hematological analysis: Red cell blood distribution width

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

    Measured: 4 months

  17. Hematological analysis: White blood cells

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

    Measured: 4 months

  18. Hematological analysis: Neutrophils

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

    Measured: 4 months

  19. Hematological analysis: Lymphocytes

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

    Measured: 4 months

  20. Hematological analysis: Monocytes

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

    Measured: 4 months

  21. Hematological analysis: Eosinophils

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

    Measured: 4 months

  22. Hematological analysis: Basophiles

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

    Measured: 4 months

  23. Hematological analysis: Platelets

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

    Measured: 4 months

  24. Hematological analysis: Mean platelet volume

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

    Measured: 4 months

  25. Biochemical analysis: Glucose

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

    Measured: 4 months

  26. Biochemical analysis: Bilirubin

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

    Measured: 4 months

  27. Biochemical analysis: Creatinine

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

    Measured: 4 months

  28. Biochemical analysis: Urate

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

    Measured: 4 months

  29. Biochemical analysis: Urea

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

    Measured: 4 months

  30. Biochemical analysis: Total protein

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

    Measured: 4 months

  31. Biochemical analysis: Aspartate aminotransferase

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

    Measured: 4 months

  32. Biochemical analysis: Alanine aminotransferase

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

    Measured: 4 months

  33. Biochemical analysis: Gamma-glutamyl transferase

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

    Measured: 4 months

  34. Biochemical analysis: Alkaline phosphatase

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

    Measured: 4 months

  35. Biochemical analysis: Total cholesterol

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

    Measured: 4 months

  36. Biochemical analysis: High density lipoproteins

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

    Measured: 4 months

  37. Biochemical analysis: Non-HDL cholesterol

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

    Measured: 4 months

  38. Biochemical analysis: Low density lipoproteins

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

    Measured: 4 months

  39. Biochemical analysis: Apolipoprotein A1

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

    Measured: 4 months

  40. Biochemical analysis: Apolipoprotein B

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

    Measured: 4 months

  41. Biochemical analysis: Calcium

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

    Measured: 4 months

  42. Biochemical analysis: Potassium

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

    Measured: 4 months

  43. 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.

    Measured: 4 months

  44. Biochemical analysis: Phosphorus

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

    Measured: 4 months

  45. Biochemical analysis: Iron

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

    Measured: 4 months

  46. Biochemical analysis: Magnesium

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

    Measured: 4 months

  47. Biochemical analysis: Zinc

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

    Measured: 4 months

  48. 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.

    Measured: 4 months

  49. Biochemical analysis: Insulin resistance

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

    Measured: 4 months

  50. Biochemical analysis: C-reactive protein

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

    Measured: 4 months

  51. Biochemical analysis: Tumor necrosis factor alpha

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

    Measured: 4 months

  52. Biochemical analysis: Adiponectin

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

    Measured: 4 months

  53. 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.

    Measured: 4 months

  54. 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.

    Measured: 4 months

  55. 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.

    Measured: 4 months

  56. Biochemical analysis: Fiber

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

    Measured: 4 months

  57. Biochemical analysis: Polysaccharides

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

    Measured: 4 months

  58. Biochemical analysis: Total fat

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

    Measured: 4 months

  59. Biochemical analysis: Saturated fatty acids

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

    Measured: 4 months

  60. Biochemical analysis: Monounsaturated fatty acids

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

    Measured: 4 months

  61. Biochemical analysis: Polyunsaturated fatty acids

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

    Measured: 4 months

  62. Biochemical analysis: Vitamin B1

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

    Measured: 4 months

  63. Biochemical analysis: Vitamin B2

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

    Measured: 4 months

  64. Biochemical analysis: Vitamin B3

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

    Measured: 4 months

  65. Biochemical analysis: Vitamin B6

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

    Measured: 4 months

  66. Biochemical analysis: Vitamin B9

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

    Measured: 4 months

  67. Biochemical analysis: Vitamin B12

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

    Measured: 4 months

  68. Biochemical analysis: Vitamin C

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

    Measured: 4 months

  69. Biochemical analysis: Vitamin A

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

    Measured: 4 months

  70. Biochemical analysis: Vitamin D

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

    Measured: 4 months

  71. Biochemical analysis: Vitamin E

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

    Measured: 4 months

  72. Biochemical analysis: Carotenes

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

    Measured: 4 months

  73. Biochemical analysis: Retinol

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

    Measured: 4 months

  74. Biochemical analysis: Water

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

    Measured: 4 months

  75. 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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start1 Mar 2022
  3. Primary completion1 Mar 2032 (estimated)
  4. Study completion1 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457412
Sponsor's protocol ID
PinPo
Acronym
PinPo
Status last verified
May 2024
First submitted
27 May 2024
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group for the treatment of childhood obesity in people with Obesity, Childhood, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mercedes Gil-Campos, MD, Phd (+34957736467, mercedes_gil_campos@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary intake (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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