NCT05862506

Brief Summary

This study is a clinical trial will be carried out during academic term to assess the potential effects of the Daily Mile program on health-related physical fitness and sleep quality on overweight/obese schoolchildren.The trial will be taken place in Bucaramanga, Colombia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

11 days

First QC Date

March 5, 2023

Last Update Submit

November 16, 2023

Conditions

Overweight AdolescentsObesity, Adolescent

Keywords

physical activityschool based programphysical fitness

Outcome Measures

Primary Outcomes (1)

  • Aerobic capacity

    maximum oxygen consumption in ml/kg\*min, distance covered in meters

    At the end of the intervention period (10 weeks)

Secondary Outcomes (5)

  • Muscle strength

    At the end of the intervention period (10 weeks)

  • Body composition

    At the end of the intervention period (10 weeks)

  • Cardiometabolic biomarkers

    At the end of the intervention period (10 weeks)

  • Physical activity level

    At the end of the intervention period (10 weeks)

  • Sleep quality

    At the end of the intervention period (10 weeks)

Study Arms (2)

The Daily Mile

EXPERIMENTAL

The intervention consisted of walking, jogging or running for \~ 15 min (\~ one mile) of exercise at a pace self-selected by each individual child, outside the school buildings during recess time, three times a week during 10 weeks. Children were instructed to maintain active for the full 15 min and, if necessary, to stop for resting only occasionally.

Behavioral: Daily Mile

Control Group

NO INTERVENTION

This group will be received only the physical education lessons and it will be followed-up equally to compare outcomes in the future.

Interventions

Daily MileBEHAVIORAL

The intervention consisted of walking, jogging or running for \~ 15 min (\~ one mile) of exercise at a pace self-selected by each individual child, outside the school buildings during recess time, three times a week during 10 weeks. Children were instructed to maintain active for the full 15 min and, if necessary, to stop for resting only occasionally.

The Daily Mile

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be enrolled at the school.
  • Be aged between 11 and 17 years, healthy (physically, psychologically and cognitively).
  • Present a BMI greater than or equal to the 85th percentile for their gender and age, according to WHO (World Health Organization).
  • Be free of any medication that could interact with the protocol (e.g., cardiac abnormalities, hypertension, diabetes, orthopaedic, neuromuscular, or neurological disorders).
  • Present no contraindication to physical activity

You may not qualify if:

  • \- Perform any scheduled physical activity outside the curricula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidades tecnológicas de Santander

Bucaramanga, Santander Department, 680005318, Colombia

Location

Related Publications (3)

  • Breheny K, Passmore S, Adab P, Martin J, Hemming K, Lancashire ER, Frew E. Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial. Int J Obes (Lond). 2020 Apr;44(4):812-822. doi: 10.1038/s41366-019-0511-0. Epub 2020 Jan 28.

    PMID: 31988481BACKGROUND

  • Chesham RA, Booth JN, Sweeney EL, Ryde GC, Gorely T, Brooks NE, Moran CN. The Daily Mile makes primary school children more active, less sedentary and improves their fitness and body composition: a quasi-experimental pilot study. BMC Med. 2018 May 10;16(1):64. doi: 10.1186/s12916-018-1049-z.

    PMID: 29743076BACKGROUND

  • Brustio PR, Mulasso A, Marasso D, Ruffa C, Ballatore A, Moise P, Lupo C, Rainoldi A, Boccia G. The Daily Mile: 15 Minutes Running Improves the Physical Fitness of Italian Primary School Children. Int J Environ Res Public Health. 2019 Oct 15;16(20):3921. doi: 10.3390/ijerph16203921.

    PMID: 31618975BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 5, 2023

First Posted

May 17, 2023

Study Start

July 10, 2023

Primary Completion

July 21, 2023

Study Completion

October 13, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)