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
About this trial
This is an interventional prevention trial for Obesity focused on measuring obesity; brisk walking
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.
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
NCT ID
NCT03125993
First Posted
April 14, 2017
Last Updated
April 21, 2017
Sponsor
Guangdong Center for Disease Prevention and Control
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.
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Effects of Brisk Walking on Overweight/Obesity Population
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