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CompletedNCT05862506Updated Nov 21, 2023

Effects of the Daily Mile Program on General Health in Overweight/Obese Schoolchildren

An interventional study of Daily Mile in Overweight Adolescents and Obesity, Adolescent, sponsored by Unidades Tecnológicas de Santander. Completed at 1 site in Colombia. Open to participants aged 11 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-21.

Sponsored by Unidades Tecnológicas de Santander · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
11 Years to 17 Years
Sex
All
01

Study 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

Read the detailed description

Introduction: Regular physical activity is essential for promoting health and well-being, especially during childhood and adolescence. The World Health Organization (WHO) recommends that children and adolescents (ages 5 to 17 years) should average 60 minutes of moderate-to-vigorous intensity physical activity per day, primarily of aerobic capacity, with the aim of preventing and/or reducing the incidence of overweight non-communicable diseases in adulthood and modifying emotional behaviors such as enjoyment, intrinsic motivation and perceived autonomy, among others. Modifications in these recommendations have probably been generated due to the increase of physical inactivity prevalence and sedentary behaviours in the population, which have been related to an increased risk of obesity, cardiovascular disease, diabetes, coronary heart disease and stroke, as well as delayed cognitive development and decreased in the academic performance of children and young people.

Recently, the WHO classified physical inactivity as the fourth mortality risk factor with 6%, after hypertension (13%), smoking (9%) and diabetes (6%)9. In Colombia, the National Survey of the Nutritional Situation (ENSIN 2015) found that only 35.8% of boys and 26% of girls between 6 and 12 years of age complied with the physical activity recommendations.

The previous Survey shows that 25.3% of boys and 23.5% of girls between 5 and 12 years of age are overweight or obese, which means an increase of 5.1%. and 6.2% respectively in relation to the year 2010 and 10.1% and 9.8% in relation to the year 2005, indicating a substantial increase in the data related to body weight In Colombia. In 2016 worldwide, it was estimated that the number of children under five years of age with obesity exceeded 41 million. In the same way, it has been found that the presence of overweight and obesity increases the probability of the development of non-communicable diseases such as diabetes, cardiovascular diseases and metabolic syndromes.

In response to this situation, one of the objectives established by the WHO's global action plan on physical activity 2018-2030 was to reduce the prevalence of physical inactivity by 10% by 2025 and 15% by 2030. For this reason, two of the strategic objectives have been called "Create active environments" and "create active people", whose purpose is to create and promote spaces and access to programs and opportunities that increase physical activity in their different communities and, that in the case of the school population, a greater participation in physical activity leads to a greater capacity for concentration and cognitive function, which could result in an improvement in academic performance.

A physical activity program to be developed in school environments is The Daily Mile (DM). It is an initiative created at St Ninian Primary School (Stirling, Scotland) in 2012 that was initially proposed as a solution to a perceived lack of physical fitness in children between 5 and 12 years of age. The DMaily Mile encompasses a 15-minute walking, jogging or running each day, without additional material resources or clothing, within their class time.

Although the Daily Mile program has grown in popularity among schools in the United Kingdom, the United States, Italy, and the Netherlands, among others, there is no evidence of research carried out on schoolchildren implementing this program in Colombia or in overweight/obese children. There is an urgent need for results from well-designed experimental studies that enable a better understanding of the impact of exercise in school environments on various health outcomes.

Methodology: The intervention will start in the middle of the first academic term. The Daily Mile intervention will be 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. Children were instructed to maintain active for the full 15 min and, if necessary, to stop for resting only occasionally. The program will be guided and supervised by physical education professionals previously trained. All the sessions will take place at the outside School buildings.

02

Conditions studied

  • Overweight Adolescents
  • Obesity, Adolescent

Keywords

  • physical activity
  • school based program
  • physical fitness
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 70 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

This is the only study on the registry with Unidades Tecnológicas de Santander as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Perform any scheduled physical activity outside the curricula.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    The Daily Mile

    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

  • No intervention
    Control Group

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

Interventions

  • BehavioralDaily Mile

    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.

06

What researchers measure

Primary outcomes

  1. Aerobic capacity

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

    Time frame: At the end of the intervention period (10 weeks)

Secondary outcomes

  1. Muscle strength

    in Newtons

    Time frame: At the end of the intervention period (10 weeks)

  2. Body composition

    In fat and muscle mass kilograms

    Time frame: At the end of the intervention period (10 weeks)

  3. Cardiometabolic biomarkers

    glucose and lipid profile in mg/dL

    Time frame: At the end of the intervention period (10 weeks)

  4. Physical activity level

    in minutes per week

    Time frame: At the end of the intervention period (10 weeks)

  5. Sleep quality

    Pittsburgh Sleep Quality Index, provides an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

    Time frame: At the end of the intervention period (10 weeks)

07

Study locations

1 site
  • Unidades tecnológicas de Santander
    Bucaramanga, Santander 680005318, Colombia
08

References and documents

Publications

  • 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. PubMed 31988481 ↗
  • 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. PubMed 29743076 ↗
  • 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. PubMed 31618975 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05862506
Lead sponsor
Unidades Tecnológicas de Santander
Collaborators
Universidad Industrial de Santander
Responsible party
Adrian Marcel De La Rosa Gonzalez (Doctor, Unidades Tecnológicas de Santander) — Principal investigator
First posted
May 17, 2023
Start date
Jul 10, 2023
Primary completion
Jul 21, 2023
Completion
Oct 13, 2023
Last update
Nov 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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