NCT07057453

Brief Summary

The project is a national, prospective, multicenter, interventional pilot project of early detection of childhood overweight and the prevention of obesity in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of childhood overweight and the prevention of obesity and setting up and testing new methods and implementation into the system of health care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Nov 2024

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Nov 2024Dec 2026

Study Start

First participant enrolled

November 19, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

May 23, 2025

Last Update Submit

July 4, 2025

Conditions

Keywords

Early detectionOverweightFitness bracelets

Outcome Measures

Primary Outcomes (1)

  • Mean percentage change in BMI of children over the intervention period

    Up to 1 year from enrollment

Secondary Outcomes (3)

  • Changes in BMI by subgroups of children (by gender, age, region, with/without playmate)

    Up to 1 year from enrollment

  • Evaluation of energy expenditure (kilojoules) measured using a fitness bracelet during the competition weeks.

    Up to 1 year from enrollment

  • Proportion of children who completed the full process (one-year participation in the program)

    Up to 1 year from enrollment

Study Arms (1)

Overweight Children

OTHER

Overweight children aged 6-11 years who will receive a fitness bracelet and use a gamified mobile app to encourage physical activity and healthy habits through interactive challenges and rewards.

Other: Motivation Engagement for Movement and Interactive Nutrition Development

Interventions

The intervention includes using of fitness bracelets, a gamified mobile app, a web portal, and regular pediatric check-ups to support healthy habits in overweight children (6-11 years). The bracelets track physical activity, while the mobile app monitors energy balance, encouraging movement and healthy eating through challenges and rewards. The web portal provides family education, and pediatric check-ups track progress and overall health outcomes.

Overweight Children

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6-11 years
  • BMI: Between the 90th and 97th percentile
  • Signed consent to participate in the project and GDPR

You may not qualify if:

  • Children with a BMI between the 90th and 97th percentile with an associated chronic disease requiring continuous pharmacological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Czech Medical Chamber

Prague, Czechia, 19000, Czechia

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityOverweight

Interventions

Movement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Petr Jehlička, PhD

    Pediatric Cardiology, Plzeň, Czech Republic

    STUDY DIRECTOR

Central Study Contacts

Michal Hink, Msc

CONTACT

Lucie Mandelová, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 23, 2025

First Posted

July 9, 2025

Study Start

November 19, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 9, 2025

Record last verified: 2025-07

Locations