Effects of Brisk Walking on Overweight/Obesity Population

April 21, 2017 updated by: Xue-yan Zheng, Guangdong Center for Disease Prevention and Control

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:

  1. The body components changes before/after the brisk walking prescription (> 10000 steps, > five days per week) intervention in overweight/obesity population;
  2. 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: >10000 steps brisk walking
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.
Behavioral: >10000 steps brisk walking
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: Change from Baseline BMI at 4 months
Body components
Change from Baseline BMI at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: Change from systolic blood pressure at 4 months
Cardiovascular risk factors
Change from systolic blood pressure at 4 months
Diastolic blood pressure
Time Frame: Change from diastolic blood pressure at 4 months
Cardiovascular risk factors
Change from diastolic blood pressure at 4 months
Plasma glucose
Time Frame: Change from Plasma glucose at 4 months
Cardiovascular risk factors
Change from Plasma glucose at 4 months
visceral fat
Time Frame: Change from visceral fat at 4 months
Cardiovascular risk factors
Change from visceral fat at 4 months
serum triglycerides
Time Frame: Change from serum triglycerides at 4 months
Cardiovascular risk factors
Change from serum triglycerides at 4 months
serum total cholesterol
Time Frame: Change from serum total cholesterol at 4 months
Cardiovascular risk factors
Change from serum total cholesterol at 4 months
high density lipoprotein-C
Time Frame: Change from high density lipoprotein-C at 4 months
Cardiovascular risk factors
Change from high density lipoprotein-C at 4 months
low density lipoprotein-C
Time Frame: Change from low density lipoprotein-C at 4 months
Cardiovascular risk factors
Change from low density lipoprotein-C at 4 months
heart rate
Time Frame: Change from heart rate at 4 months
Cardiovascular risk factors
Change from heart rate at 4 months
abdominal circumstance
Time Frame: Change from abdominal circumstance at 4 months
Body components
Change from abdominal circumstance at 4 months
body fat percentage
Time Frame: Change from body fat percentage at 4 months
Body components
Change from body fat percentage at 4 months
visceral fat percentage
Time Frame: Change from visceral fat percentage at 4 months
Body components
Change from visceral fat percentage at 4 months
waist circumstance/hip circumstance
Time Frame: Change from waist circumstance/hip circumstance at 4 months
Body components
Change from waist circumstance/hip circumstance at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Center for Disease Prevention and Control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 25, 2017

Primary Completion (Anticipated)

August 25, 2017

Study Completion (Anticipated)

August 30, 2017

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWOE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

individual participant data will not be shared with other researchers, for data safety.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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