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

Primary Purpose

Overweight Adolescents, Obesity, Adolescent

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daily Mile
Sponsored by
Unidades Tecnológicas de Santander
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight Adolescents focused on measuring physical activity, school based program, physical fitness

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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: - Perform any scheduled physical activity outside the curricula.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    The Daily Mile

    Control Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Muscle strength
    in Newtons
    Body composition
    In fat and muscle mass kilograms
    Cardiometabolic biomarkers
    glucose and lipid profile in mg/dL
    Physical activity level
    in minutes per week
    Sleep quality
    Pittsburgh Sleep Quality Index, provides an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

    Full Information

    First Posted
    March 5, 2023
    Last Updated
    May 14, 2023
    Sponsor
    Unidades Tecnológicas de Santander
    Collaborators
    Universidad Industrial de Santander
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05862506
    Brief Title
    Effects of the Daily Mile Program on General Health in Overweight/Obese Schoolchildren
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 10, 2023 (Anticipated)
    Primary Completion Date
    July 21, 2023 (Anticipated)
    Study Completion Date
    October 13, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Unidades Tecnológicas de Santander
    Collaborators
    Universidad Industrial de Santander

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight Adolescents, Obesity, Adolescent
    Keywords
    physical activity, school based program, physical fitness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Daily Mile
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    This group will be received only the physical education lessons and it will be followed-up equally to compare outcomes in the future.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Daily Mile
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Aerobic capacity
    Description
    maximum oxygen consumption in ml/kg*min, distance covered in meters
    Time Frame
    At the end of the intervention period (10 weeks)
    Secondary Outcome Measure Information:
    Title
    Muscle strength
    Description
    in Newtons
    Time Frame
    At the end of the intervention period (10 weeks)
    Title
    Body composition
    Description
    In fat and muscle mass kilograms
    Time Frame
    At the end of the intervention period (10 weeks)
    Title
    Cardiometabolic biomarkers
    Description
    glucose and lipid profile in mg/dL
    Time Frame
    At the end of the intervention period (10 weeks)
    Title
    Physical activity level
    Description
    in minutes per week
    Time Frame
    At the end of the intervention period (10 weeks)
    Title
    Sleep quality
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: - Perform any scheduled physical activity outside the curricula.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adrián De La Rosa González, PhD
    Phone
    3209303139
    Email
    adelarosa@correo.uts.edu.co

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31988481
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29743076
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31618975
    Citation
    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.
    Results Reference
    background

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

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