ObesityNCT03125993
Effects of Brisk Walking on Overweight/Obesity Population
A study testing >10000 steps brisk walking in people with Obesity, run by Guangdong Center for Disease Prevention and Control.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- >10000 steps brisk walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants were excluded with the presence of significant cardiac or pulmonary disease that could result in hypoxia or decreased perfusion.
About this study
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:
Read more
- 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.
- 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- >10000 steps brisk walking
- Keywords
- obesity; brisk walking
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
>10000 steps brisk walkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| >10000 steps brisk walking | Experimental | 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. Receives: Behavioral: >10000 steps brisk walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body components
Measured: Change from Baseline BMI at 4 months
Secondary outcomes (13)
Systolic blood pressure
Cardiovascular risk factors
Measured: Change from systolic blood pressure at 4 months
Diastolic blood pressure
Cardiovascular risk factors
Measured: Change from diastolic blood pressure at 4 months
Plasma glucose
Cardiovascular risk factors
Measured: Change from Plasma glucose at 4 months
visceral fat
Cardiovascular risk factors
Measured: Change from visceral fat at 4 months
serum triglycerides
Cardiovascular risk factors
Measured: Change from serum triglycerides at 4 months
serum total cholesterol
Cardiovascular risk factors
Measured: Change from serum total cholesterol at 4 months
high density lipoprotein-C
Cardiovascular risk factors
Measured: Change from high density lipoprotein-C at 4 months
low density lipoprotein-C
Cardiovascular risk factors
Measured: Change from low density lipoprotein-C at 4 months
heart rate
Cardiovascular risk factors
Measured: Change from heart rate at 4 months
abdominal circumstance
Body components
Measured: Change from abdominal circumstance at 4 months
body fat percentage
Body components
Measured: Change from body fat percentage at 4 months
visceral fat percentage
Body components
Measured: Change from visceral fat percentage at 4 months
waist circumstance/hip circumstance
Body components
Measured: Change from waist circumstance/hip circumstance at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start25 Apr 2017 (estimated)
- Primary completion25 Aug 2017 (estimated)
- Study completion30 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Center for Disease Prevention and Control
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xue-yan Zheng, Guangdong Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125993
- Sponsor's protocol ID
- BWOE
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared with other researchers, for data safety.
Publications
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.
PubMed 20071471Hubert 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. doi: 10.1161/01.cir.67.5.968.
PubMed 6219830Lee 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.
PubMed 21366838Swift 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.
PubMed 24438736Hills 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.
PubMed 20003071Hills 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. doi: 10.1016/j.ypmed.2005.10.010. Epub 2005 Dec 1.
PubMed 16325248Williams 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.
PubMed 18385193Ikenaga 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.
PubMed 27848017Schutz 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.
PubMed 25137221Takahashi 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.
PubMed 27621602
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brisk Walking on Overweight/Obesity Population
- ClinicalTrials.gov ID
- NCT03125993
- Acronym / sponsor ID
- BWOE
- Conditions
- Obesity
- Keywords
- obesity; brisk walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangdong Center for Disease Prevention and ControlOther government
- Study start
- 25 Apr 2017 (estimated)
- Primary completion
- 25 Aug 2017 (estimated)
- Study completion
- 30 Aug 2017 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| >10000 steps brisk walking | Experimental | Behavioral: >10000 steps brisk walkingThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The inclusion criterion is individual with sedentary behaviors, adding any of the following behavior:
Key exclusion criteria (1 listed)
- Participants were excluded with the presence of significant cardiac or pulmonary disease that could result in hypoxia or decreased perfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| >10000 steps brisk walkingThis 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. | Behavioural | >10000 steps brisk walking |
Primary outcome
BMI
Time frame: Change from Baseline BMI at 4 months
Body components
13 secondary outcomes
Systolic blood pressure
Time frame: Change from systolic blood pressure at 4 months
Diastolic blood pressure
Time frame: Change from diastolic blood pressure at 4 months
Plasma glucose
Time frame: Change from Plasma glucose at 4 months
visceral fat
Time frame: Change from visceral fat at 4 months
serum triglycerides
Time frame: Change from serum triglycerides at 4 months
serum total cholesterol
Time frame: Change from serum total cholesterol at 4 months
high density lipoprotein-C
Time frame: Change from high density lipoprotein-C at 4 months
low density lipoprotein-C
Time frame: Change from low density lipoprotein-C at 4 months
heart rate
Time frame: Change from heart rate at 4 months
abdominal circumstance
Time frame: Change from abdominal circumstance at 4 months
body fat percentage
Time frame: Change from body fat percentage at 4 months
visceral fat percentage
Time frame: Change from visceral fat percentage at 4 months
waist circumstance/hip circumstance
Time frame: Change from waist circumstance/hip circumstance at 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Background: PubMed 20071471Flegal 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.
- Background: PubMed 6219830Hubert 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. doi: 10.1161/01.cir.67.5.968.
- Background: PubMed 21366838Lee 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.
- Background: PubMed 24438736Swift 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.
- Background: PubMed 20003071Hills 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.
- Background: PubMed 16325248Hills 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. doi: 10.1016/j.ypmed.2005.10.010. Epub 2005 Dec 1.
- Background: PubMed 18385193Williams 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.
- Background: PubMed 27848017Ikenaga 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.
- Background: PubMed 25137221Schutz 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.
- Background: PubMed 27621602Takahashi 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.
- Individual participant dataSharing planned: No. individual participant data will not be shared with other researchers, for data safety.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing >10000 steps brisk walking in people with Obesity, run by Guangdong Center for Disease Prevention and Control.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: Change from Baseline BMI at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03125993, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.