Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-27 @ 3:07 AM
Study NCT ID:
NCT03125993
Status:
UNKNOWN
Last Update Posted:
2017-04-24
First Post:
2017-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Brisk Walking on Overweight/Obesity Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Change from Baseline BMI at 4 months', 'description': 'Body components'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'Change from systolic blood pressure at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'Change from diastolic blood pressure at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'Plasma glucose', 'timeFrame': 'Change from Plasma glucose at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'visceral fat', 'timeFrame': 'Change from visceral fat at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'serum triglycerides', 'timeFrame': 'Change from serum triglycerides at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'serum total cholesterol', 'timeFrame': 'Change from serum total cholesterol at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'high density lipoprotein-C', 'timeFrame': 'Change from high density lipoprotein-C at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'low density lipoprotein-C', 'timeFrame': 'Change from low density lipoprotein-C at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'heart rate', 'timeFrame': 'Change from heart rate at 4 months', 'description': 'Cardiovascular risk factors'}, {'measure': 'abdominal circumstance', 'timeFrame': 'Change from abdominal circumstance at 4 months', 'description': 'Body components'}, {'measure': 'body fat percentage', 'timeFrame': 'Change from body fat percentage at 4 months', 'description': 'Body components'}, {'measure': 'visceral fat percentage', 'timeFrame': 'Change from visceral fat percentage at 4 months', 'description': 'Body components'}, {'measure': 'waist circumstance/hip circumstance', 'timeFrame': 'Change from waist circumstance/hip circumstance at 4 months', 'description': 'Body components'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity; brisk walking'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '20071471', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6219830', 'type': 'BACKGROUND', '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. doi: 10.1161/01.cir.67.5.968.'}, {'pmid': '21366838', 'type': 'BACKGROUND', '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.'}, {'pmid': '24438736', 'type': 'BACKGROUND', '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.'}, {'pmid': '20003071', 'type': 'BACKGROUND', '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.'}, {'pmid': '16325248', 'type': 'BACKGROUND', '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. doi: 10.1016/j.ypmed.2005.10.010. Epub 2005 Dec 1.'}, {'pmid': '18385193', 'type': 'BACKGROUND', '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.'}, {'pmid': '27848017', 'type': 'BACKGROUND', '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.'}, {'pmid': '25137221', 'type': 'BACKGROUND', '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.'}, {'pmid': '27621602', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '1.Objective\n\nThe 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:\n\n1. The body components changes before/after the brisk walking prescription (\\> 10000 steps, \\> five days per week) intervention in overweight/obesity population;\n2. The metabolic risk factors changes before/after the brisk walking prescription (\\<10000 steps or \\<five days per week) intervention in overweight/obesity population\n\n2.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.\n\n3\\. 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.', 'detailedDescription': '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.\n\nIn 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 .\n\nNumerous 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.\n\nSeveral 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The inclusion criterion is individual with sedentary behaviors, adding any of the following behavior:\n\n 1. individuals with BMI ≥24 kg/m2\n 2. waist circumstance ≥102cm in male; waist circumstance ≥88cm in female;\n 3. waist circumstance/hip circumstance\\>1.0 in male; waist circumstance/hip circumstance\\> 0.9 in female.\n\nExclusion Criteria:\n\n\\- Participants were excluded with the presence of significant cardiac or pulmonary disease that could result in hypoxia or decreased perfusion.'}, 'identificationModule': {'nctId': 'NCT03125993', 'briefTitle': 'Effects of Brisk Walking on Overweight/Obesity Population', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Guangdong Center for Disease Prevention and Control'}, 'officialTitle': 'Effects of Brisk Walking on Overweight/Obesity Population', 'orgStudyIdInfo': {'id': 'BWOE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '>10000 steps brisk walking', '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.', 'interventionNames': ['Behavioral: >10000 steps brisk walking']}], 'interventions': [{'name': '>10000 steps brisk walking', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['>10000 steps brisk walking']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data will not be shared with other researchers, for data safety.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Center for Disease Prevention and Control', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Xue-yan Zheng', 'investigatorAffiliation': 'Guangdong Center for Disease Prevention and Control'}}}}