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Effects of Brisk Walking on Overweight/Obesity Population

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
>10000 steps brisk walking
Sponsored by
Guangdong Center for Disease Prevention and Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity; brisk walking

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The inclusion criterion is individual with sedentary behaviors, adding any of the following behavior:

    1. individuals with BMI ≥24 kg/m2
    2. waist circumstance ≥102cm in male; waist circumstance ≥88cm in female;
    3. waist circumstance/hip circumstance>1.0 in male; waist circumstance/hip circumstance> 0.9 in female.

Exclusion Criteria:

- Participants were excluded with the presence of significant cardiac or pulmonary disease that could result in hypoxia or decreased perfusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    >10000 steps brisk walking

    Arm Description

    This study is a prospective 4-month follow-up scheme in which patients were treated with the following intervention: > 10000 steps, > five days, per week. For individual follow-up, body components and metabolic risk factors will be tested before and after the study.

    Outcomes

    Primary Outcome Measures

    BMI
    Body components

    Secondary Outcome Measures

    Systolic blood pressure
    Cardiovascular risk factors
    Diastolic blood pressure
    Cardiovascular risk factors
    Plasma glucose
    Cardiovascular risk factors
    visceral fat
    Cardiovascular risk factors
    serum triglycerides
    Cardiovascular risk factors
    serum total cholesterol
    Cardiovascular risk factors
    high density lipoprotein-C
    Cardiovascular risk factors
    low density lipoprotein-C
    Cardiovascular risk factors
    heart rate
    Cardiovascular risk factors
    abdominal circumstance
    Body components
    body fat percentage
    Body components
    visceral fat percentage
    Body components
    waist circumstance/hip circumstance
    Body components

    Full Information

    First Posted
    April 14, 2017
    Last Updated
    April 21, 2017
    Sponsor
    Guangdong Center for Disease Prevention and Control
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03125993
    Brief Title
    Effects of Brisk Walking on Overweight/Obesity Population
    Official Title
    Effects of Brisk Walking on Overweight/Obesity Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 25, 2017 (Anticipated)
    Primary Completion Date
    August 25, 2017 (Anticipated)
    Study Completion Date
    August 30, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangdong Center for Disease Prevention and Control

    4. Oversight

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

    5. Study Description

    Brief Summary
    1.Objective The investigators aim to determine the effect of brisk walking prescription (> 10000 steps, > five days, per week) on body components and metabolic risk factors among patients with overweight/obesity. The objectives are as follow: The body components changes before/after the brisk walking prescription (> 10000 steps, > five days per week) intervention in overweight/obesity population; The metabolic risk factors changes before/after the brisk walking prescription (<10000 steps or <five days per week) intervention in overweight/obesity population 2.Study design This study is a prospective 4-month follow-up scheme in which patients were treated with the following intervention: > 10000 steps, > five days, per week. For individual follow-up, body components and metabolic risk factors will be tested before and after the study. Every participants will be followed up in community visits every month. 3. Statistical analysis Statistical analysis will be performed using SPSS 16.0 version package (SPSS Inc., Chicago, IL.). Numerical data will be presented as mean ± standard deviation for normal distribution or otherwise median (interquartile range). Two-sided independent t-test is adopted for between-group comparison on end-points with normal distribution, otherwise non-parametric test. Row-Column table will be analyzed through chi-square test. P<0.05 is taken as statistical significant.
    Detailed Description
    Obesity/overweight has been recognized as one of the most important global health threats worldwide, which is closely related to metabolism syndrome including insulin resistance, hypertension, dyslipidemia and hyperglycemia. In 2013, an estimated 36.9% of men and 38.0% of women were overweight (BMI >25 kg/m2) worldwide, with attributable fractions for CHD as high as 25% in the United States and 58% in the Asia-Pacific Region. Furthermore, a strong and continuous association between body mass index (BMI) and coronary heart disease (CHD) has been reported for values of BMI above 20kg/m2 . Numerous studies have recognized the role of physical activity in promoting moderate weight loss, weight loss maintenance, and having broad-reaching implications for cardiovascular disease mortality indices, as well as reducing healthcare expenditures. The findings of a recent review suggest that mild-to-moderate intensity exercises that include both aerobic and resistance training result in additional metabolic benefits in people with obesity or type 2 diabetes. Although weight loss is minimal, body composition improves. Brisk walking, at an individual level, prove to be the physical activity most easy to maintain and could be progressively increased in intensity, achieving a cardiorespiratory benefit and decrease adiposity in the unfit. Several small clinical trials reported inconsistent findings of short-term exercise programs on brisk walking among patients with overweight/obesity. However, these studies did not provide comparable indices, duration and intensity. Furthermore, the brisk walking effect of current physical activity guidelines on obesity/overweight is uncertain. The current study aimed to evaluate the effects of brisk walking ( > 10000 steps, > five days, per week) on body components and metabolic risk factors among patients with overweight/obesity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    obesity; brisk walking

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This study is a prospective 4-month follow-up scheme in which patients were treated with the following intervention: > 10000 steps, > five days, per week. For individual follow-up, body components and metabolic risk factors will be tested before and after the study. Every participants will be followed up in community visits every month.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    >10000 steps brisk walking
    Arm Type
    Experimental
    Arm Description
    This study is a prospective 4-month follow-up scheme in which patients were treated with the following intervention: > 10000 steps, > five days, per week. For individual follow-up, body components and metabolic risk factors will be tested before and after the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    >10000 steps brisk walking
    Intervention Description
    This study is a prospective 4-month follow-up scheme in which patients were treated with the following intervention: > 10000 steps, > five days, per week brisk walking.
    Primary Outcome Measure Information:
    Title
    BMI
    Description
    Body components
    Time Frame
    Change from Baseline BMI at 4 months
    Secondary Outcome Measure Information:
    Title
    Systolic blood pressure
    Description
    Cardiovascular risk factors
    Time Frame
    Change from systolic blood pressure at 4 months
    Title
    Diastolic blood pressure
    Description
    Cardiovascular risk factors
    Time Frame
    Change from diastolic blood pressure at 4 months
    Title
    Plasma glucose
    Description
    Cardiovascular risk factors
    Time Frame
    Change from Plasma glucose at 4 months
    Title
    visceral fat
    Description
    Cardiovascular risk factors
    Time Frame
    Change from visceral fat at 4 months
    Title
    serum triglycerides
    Description
    Cardiovascular risk factors
    Time Frame
    Change from serum triglycerides at 4 months
    Title
    serum total cholesterol
    Description
    Cardiovascular risk factors
    Time Frame
    Change from serum total cholesterol at 4 months
    Title
    high density lipoprotein-C
    Description
    Cardiovascular risk factors
    Time Frame
    Change from high density lipoprotein-C at 4 months
    Title
    low density lipoprotein-C
    Description
    Cardiovascular risk factors
    Time Frame
    Change from low density lipoprotein-C at 4 months
    Title
    heart rate
    Description
    Cardiovascular risk factors
    Time Frame
    Change from heart rate at 4 months
    Title
    abdominal circumstance
    Description
    Body components
    Time Frame
    Change from abdominal circumstance at 4 months
    Title
    body fat percentage
    Description
    Body components
    Time Frame
    Change from body fat percentage at 4 months
    Title
    visceral fat percentage
    Description
    Body components
    Time Frame
    Change from visceral fat percentage at 4 months
    Title
    waist circumstance/hip circumstance
    Description
    Body components
    Time Frame
    Change from waist circumstance/hip circumstance at 4 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The inclusion criterion is individual with sedentary behaviors, adding any of the following behavior: individuals with BMI ≥24 kg/m2 waist circumstance ≥102cm in male; waist circumstance ≥88cm in female; waist circumstance/hip circumstance>1.0 in male; waist circumstance/hip circumstance> 0.9 in female. Exclusion Criteria: - Participants were excluded with the presence of significant cardiac or pulmonary disease that could result in hypoxia or decreased perfusion.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    individual participant data will not be shared with other researchers, for data safety.
    Citations:
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    20071471
    Citation
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    Citation
    Hills AP, Shultz SP, Soares MJ, Byrne NM, Hunter GR, King NA, Misra A. Resistance training for obese, type 2 diabetic adults: a review of the evidence. Obes Rev. 2010 Oct;11(10):740-9. doi: 10.1111/j.1467-789X.2009.00692.x.
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    Citation
    Williams PT. Association between walking distance and percentiles of body mass index in older and younger men. Br J Sports Med. 2008 May;42(5):352-6. doi: 10.1136/bjsm.2007.041822. Epub 2008 Apr 2.
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    Ikenaga M, Yamada Y, Kose Y, Morimura K, Higaki Y, Kiyonaga A, Tanaka H; Nakagawa Study Group. Effects of a 12-week, short-interval, intermittent, low-intensity, slow-jogging program on skeletal muscle, fat infiltration, and fitness in older adults: randomized controlled trial. Eur J Appl Physiol. 2017 Jan;117(1):7-15. doi: 10.1007/s00421-016-3493-9. Epub 2016 Nov 15.
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    Effects of Brisk Walking on Overweight/Obesity Population

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