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.
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
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.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
Mercedes Gil-Campos, PhD, MD, mercedes_gil_campos@yahoo.es
Mercedes Gil-Campos
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.
- Conditions
- Obesity, Childhood
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention 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.
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
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)
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
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
Height
Height in centimeters is measured with the SECA 213 precision measuring instrument.
Measured: 4 months
Weight
Weight in grams is measured by the precision weighing scale model Tanita 780PMA
Measured: 4 months
Body mass index
Body mass index in kilograms per square meter is calculated.
Measured: 4 months
Waist circumference
Waist circumference in centimeters is measured with a CESCORF measuring tape
Measured: 4 months
Self-esteem
Self-esteem will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.
Measured: 4 months
Confidence
Confidence will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.
Measured: 4 months
Emotional Regulation
Emotional regulation will be evaluated using ad hoc questionnaires. It will be measured by obtaining a score.
Measured: 4 months
Hematological analysis: Hemoglobine
Hemoglobin levels are determined in grams per deciliter on an individual basis.
Measured: 4 months
Hematological analysis: Hematocrite
Hematocrite levels are determined in percentage on an individual basis.
Measured: 4 months
Hematological analysis: Erythrocytes
Erythrocytes count is measured in 10e06 units per microliter on an individual basis.
Measured: 4 months
Hematological analysis: Mean corpuscular volume
Mean corpuscular volume is measured in femtoliters on an individual basis.
Measured: 4 months
Hematological analysis: Mean corpuscular hemoglobin
Mean corpuscular hemoglobine is measured in picograms on an individual basis.
Measured: 4 months
Hematological analysis: Mean corpuscular hemoglobin concentration
Mean corpuscular hemoglobine concentration is measured in grams per deciliter on an individual basis.
Measured: 4 months
Hematological analysis: Red cell blood distribution width
Red cell blood distribution width is determined in percentage on an individual basis.
Measured: 4 months
Hematological analysis: White blood cells
White blood cells count is measured in 10e03 units per microliter on an individual basis.
Measured: 4 months
Hematological analysis: Neutrophils
Neutrophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 4 months
Hematological analysis: Lymphocytes
Lymphocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 4 months
Hematological analysis: Monocytes
Monocytes count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 4 months
Hematological analysis: Eosinophils
Eosinophils count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 4 months
Hematological analysis: Basophiles
Basophiles count is measured both in 10e03 units per microliter and in percentage on an individual basis.
Measured: 4 months
Hematological analysis: Platelets
Platelets count is measured in 10e03 units per microliter on an individual basis.
Measured: 4 months
Hematological analysis: Mean platelet volume
Mean platelet volume is measured in femtoliters on an individual basis.
Measured: 4 months
Biochemical analysis: Glucose
Glucose is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Bilirubin
Total bilirubin is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma
Measured: 4 months
Biochemical analysis: Creatinine
Creatinine is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Urate
Urate is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Urea
Urea is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Measured: 4 months
Biochemical analysis: Aspartate aminotransferase
Aspartate aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Alanine aminotransferase
Alanine aminotransferase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Measured: 4 months
Biochemical analysis: Alkaline phosphatase
Alkaline phosphatase is measured in international units per liter on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Total cholesterol
Total cholesterol is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Biochemical analysis: Apolipoprotein A1
Apolipoprotein A1 is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Apolipoprotein B
Apolipoprotein B is measured in milligrams per deciliter on an individual basis. Analysis performed in plasma.
Measured: 4 months
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
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
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
Biochemical analysis: Phosphorus
Phosphorus is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Iron
Iron is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Magnesium
Magnesium is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Zinc
Zinc is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 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.
Measured: 4 months
Biochemical analysis: Insulin resistance
The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index is used to estimate insulin resistance.
Measured: 4 months
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
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
Biochemical analysis: Adiponectin
Adiponectin is measured in milligrams per liter on an individual basis. Analysis performed in plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Biochemical analysis: Fiber
Fibers are measured in grams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Polysaccharides
Polysaccharides are measured in grams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Total fat
Total fat is measured in grams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Saturated fatty acids
Saturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Monounsaturated fatty acids
Monounsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Polyunsaturated fatty acids
Polyunsaturated fatty acids are measured in grams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin B1
Vitamin B1 is measured in milligrams on an individual basis. Analysis performed in plasma
Measured: 4 months
Biochemical analysis: Vitamin B2
Vitamin B2 is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin B3
Vitamin B3 is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin B6
Vitamin B6 is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin B9
Vitamin B9 is measured in micrograms on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin B12
Vitamin B12 is measured in micrograms on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin C
Vitamin C is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin A
Vitamin A is measured in micrograms on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin D
Vitamin D is measured in micrograms on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Vitamin E
Vitamin E is measured in milligrams on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Carotenes
Carotenes are measured in micrograms on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Retinol
Retinol is measured in micrograms on an individual basis. Analysis performed in plasma.
Measured: 4 months
Biochemical analysis: Water
Water is measured in grams on an individual basis. Analysis performed in plasma.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Mar 2022
- Primary completion1 Mar 2032 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Universidad de Córdoba
- Responsible party
- Sponsor
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