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Overweight AdolescentsNCT05862506

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

A study testing Daily Mile in people with Overweight Adolescents and Obesity, Adolescent, run by Unidades Tecnológicas de Santander at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Overweight Adolescents, Obesity, Adolescent
What is being tested?
Daily Mile
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteColombia
Study dates
10 Jul 2023to 13 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Perform any scheduled physical activity outside the curricula.

Trial locations and contacts

1 site in 1 country.

Colombia1 site
  • Unidades tecnológicas de Santander

    Bucaramanga, Santander Department, 680005318

Other trials in Colombia

About this study

Official title: Effects of the Daily Mile Program on Health - Related Physical Fitness and Sleep Quality in Overweight/Obese Schoolchildren: a Non- Randomized Clinical Trial

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.

Being tested
Daily Mile
Keywords
physical activity, school based program, physical fitness
Medical subject headings
Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily MileBehavioural

    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.

Study groups in NCT05862506
Study groupRoleWhat they receive
The Daily MileExperimentalThe 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.
Receives: Behavioral: Daily Mile
Control GroupNo interventionThis group will be received only the physical education lessons and it will be followed-up equally to compare outcomes in the future.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aerobic capacity

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

    Measured: At the end of the intervention period (10 weeks)

Secondary outcomes (5)
  1. Muscle strength

    in Newtons

    Measured: At the end of the intervention period (10 weeks)

  2. Body composition

    In fat and muscle mass kilograms

    Measured: At the end of the intervention period (10 weeks)

  3. Cardiometabolic biomarkers

    glucose and lipid profile in mg/dL

    Measured: At the end of the intervention period (10 weeks)

  4. Physical activity level

    in minutes per week

    Measured: 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.

    Measured: At the end of the intervention period (10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start10 Jul 2023
  3. Primary completion21 Jul 2023
  4. Study completion13 Oct 2023

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862506
Sponsor's protocol ID
BI - 404
Status last verified
Nov 2023
First submitted
5 Mar 2023
Last updated
21 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Daily Mile in people with Overweight Adolescents and Obesity, Adolescent, run by Unidades Tecnológicas de Santander at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerobic capacity (time frame: At the end of the intervention period (10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05862506, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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