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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03125993
Other study ID # BWOE
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 14, 2017
Last updated April 21, 2017
Start date April 25, 2017
Est. completion date August 30, 2017

Study information

Verified date April 2017
Source Guangdong Center for Disease Prevention and Control
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date August 30, 2017
Est. primary completion date August 25, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Center for Disease Prevention and Control

References & Publications (10)

Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13. — View Citation

Hills AP, Byrne NM, Wearing S, Armstrong T. Validation of the intensity of walking for pleasure in obese adults. Prev Med. 2006 Jan;42(1):47-50. Epub 2005 Dec 1. — View 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. Review. — View Citation

Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983 May;67(5):968-77. — View Citation

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. — View Citation

Lee CM, Colagiuri S, Ezzati M, Woodward M. The burden of cardiovascular disease associated with high body mass index in the Asia-Pacific region. Obes Rev. 2011 May;12(5):e454-9. doi: 10.1111/j.1467-789X.2010.00849.x. Epub 2011 Mar 2. Review. — View Citation

Schutz Y, Nguyen DM, Byrne NM, Hills AP. Effectiveness of three different walking prescription durations on total physical activity in normal- and overweight women. Obes Facts. 2014;7(4):264-73. doi: 10.1159/000365833. Epub 2014 Aug 1. — View Citation

Swift DL, Johannsen NM, Lavie CJ, Earnest CP, Church TS. The role of exercise and physical activity in weight loss and maintenance. Prog Cardiovasc Dis. 2014 Jan-Feb;56(4):441-7. doi: 10.1016/j.pcad.2013.09.012. Epub 2013 Oct 11. Review. — View Citation

Takahashi PY, Quigg SM, Croghan IT, Schroeder DR, Ebbert JO. Effect of pedometer use and goal setting on walking and functional status in overweight adults with multimorbidity: a crossover clinical trial. Clin Interv Aging. 2016 Sep 1;11:1099-106. doi: 10.2147/CIA.S107626. eCollection 2016. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary BMI Body components Change from Baseline BMI at 4 months
Secondary Systolic blood pressure Cardiovascular risk factors Change from systolic blood pressure at 4 months
Secondary Diastolic blood pressure Cardiovascular risk factors Change from diastolic blood pressure at 4 months
Secondary Plasma glucose Cardiovascular risk factors Change from Plasma glucose at 4 months
Secondary visceral fat Cardiovascular risk factors Change from visceral fat at 4 months
Secondary serum triglycerides Cardiovascular risk factors Change from serum triglycerides at 4 months
Secondary serum total cholesterol Cardiovascular risk factors Change from serum total cholesterol at 4 months
Secondary high density lipoprotein-C Cardiovascular risk factors Change from high density lipoprotein-C at 4 months
Secondary low density lipoprotein-C Cardiovascular risk factors Change from low density lipoprotein-C at 4 months
Secondary heart rate Cardiovascular risk factors Change from heart rate at 4 months
Secondary abdominal circumstance Body components Change from abdominal circumstance at 4 months
Secondary body fat percentage Body components Change from body fat percentage at 4 months
Secondary visceral fat percentage Body components Change from visceral fat percentage at 4 months
Secondary waist circumstance/hip circumstance Body components Change from waist circumstance/hip circumstance at 4 months
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