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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Overweight Adolescents, Obesity, Adolescent
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Muscle strength
in Newtons
Measured: At the end of the intervention period (10 weeks)
Body composition
In fat and muscle mass kilograms
Measured: At the end of the intervention period (10 weeks)
Cardiometabolic biomarkers
glucose and lipid profile in mg/dL
Measured: At the end of the intervention period (10 weeks)
Physical activity level
in minutes per week
Measured: At the end of the intervention period (10 weeks)
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.
- First posted17 May 2023
- Study start10 Jul 2023
- Primary completion21 Jul 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight AdolescentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Unidades Tecnológicas de Santander
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Industrial de Santander
- Responsible party
- Principal investigator, Adrian Marcel De La Rosa Gonzalez, Unidades Tecnológicas de Santander
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 31988481Chesham 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 29743076Brustio 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05862506
- Acronym / sponsor ID
- BI - 404
- Conditions
- Overweight Adolescents, Obesity, Adolescent
- Keywords
- physical activity, school based program, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Unidades Tecnológicas de SantanderUniversity, hospital or other
- Collaborators
- Universidad Industrial de Santander
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Daily Mile | Experimental | Behavioral: Daily MileThe 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. |
| 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Perform any scheduled physical activity outside the curricula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily MileThe 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. | Behavioural | The Daily Mile |
Primary outcome
Aerobic capacity
Time frame: At the end of the intervention period (10 weeks)
maximum oxygen consumption in ml/kg*min, distance covered in meters
5 secondary outcomes
Muscle strength
Time frame: At the end of the intervention period (10 weeks)
Body composition
Time frame: At the end of the intervention period (10 weeks)
Cardiometabolic biomarkers
Time frame: At the end of the intervention period (10 weeks)
Physical activity level
Time frame: At the end of the intervention period (10 weeks)
Sleep quality
Time frame: At the end of the intervention period (10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 31988481Breheny 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.
- Background: PubMed 29743076Chesham 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.
- Background: PubMed 31618975Brustio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.