Clinical trial NCT03125993: Effects of Brisk Walking on Overweight/Obesity Population
Official title: Effects of Brisk Walking on Overweight/Obesity Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity; brisk walking
Lead sponsor: Guangdong Center for Disease Prevention and Control
Sponsor class: OTHER_GOV
First posted: 2017-04-24
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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:

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI
timeFrame: Change from Baseline BMI at 4 months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from systolic blood pressure at 4 months
measure: Diastolic blood pressure
timeFrame: Change from diastolic blood pressure at 4 months
measure: Plasma glucose
timeFrame: Change from Plasma glucose at 4 months
measure: visceral fat
timeFrame: Change from visceral fat at 4 months
measure: serum triglycerides
timeFrame: Change from serum triglycerides at 4 months
measure: serum total cholesterol
timeFrame: Change from serum total cholesterol at 4 months
measure: high density lipoprotein-C
timeFrame: Change from high density lipoprotein-C at 4 months
measure: low density lipoprotein-C
timeFrame: Change from low density lipoprotein-C at 4 months
measure: heart rate
timeFrame: Change from heart rate at 4 months
measure: abdominal circumstance
timeFrame: Change from abdominal circumstance at 4 months
measure: body fat percentage
timeFrame: Change from body fat percentage at 4 months
measure: visceral fat percentage
timeFrame: Change from visceral fat percentage at 4 months
measure: waist circumstance/hip circumstance
timeFrame: Change from waist circumstance/hip circumstance at 4 months
Other outcomes:
Locations:
Study officials:
References:
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