NCT06457412

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
71mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2022Mar 2032

Study Start

First participant enrolled

March 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

June 13, 2024

Status Verified

May 1, 2024

Enrollment Period

10 years

First QC Date

May 27, 2024

Last Update Submit

June 7, 2024

Conditions

Obesity, Childhood

Keywords

ObesityChildhoodGrupal intervention

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 months

Secondary Outcomes (75)

  • Physical activity and sedentary behavior

    4 months

  • Screen Time

    4 months

  • Height

    4 months

  • Weight

    4 months

  • Body mass index

    4 months

  • +70 more secondary outcomes

Study Arms (1)

Intervention Group

EXPERIMENTAL

Intervention group for the treatment of childhood obesity

Other: Intervention group for the treatment of childhood obesity

Interventions

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.

Intervention Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, Spain

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mercedes Gil-Campos, MD, Phd

CONTACT

+34957736467mercedes_gil_campos@yahoo.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 13, 2024

Study Start

March 1, 2022

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Last Updated

June 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)