NCT03125993

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

4 months

First QC Date

April 14, 2017

Last Update Submit

April 21, 2017

Conditions

Keywords

obesity; brisk walking

Outcome Measures

Primary Outcomes (1)

  • BMI

    Body components

    Change from Baseline BMI at 4 months

Secondary Outcomes (13)

  • Systolic blood pressure

    Change from systolic blood pressure at 4 months

  • Diastolic blood pressure

    Change from diastolic blood pressure at 4 months

  • Plasma glucose

    Change from Plasma glucose at 4 months

  • visceral fat

    Change from visceral fat at 4 months

  • serum triglycerides

    Change from serum triglycerides at 4 months

  • +8 more secondary outcomes

Study Arms (1)

>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.

Behavioral: >10000 steps brisk walking

Interventions

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.

>10000 steps brisk walking

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- Participants were excluded with the presence of significant cardiac or pulmonary disease that could result in hypoxia or decreased perfusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 20071471BACKGROUND
  • 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: 6219830BACKGROUND
  • 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: 21366838BACKGROUND
  • 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: 24438736BACKGROUND
  • 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: 20003071BACKGROUND
  • 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: 16325248BACKGROUND
  • 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: 18385193BACKGROUND
  • 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: 27848017BACKGROUND
  • 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: 25137221BACKGROUND
  • 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.

    PMID: 27621602BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 24, 2017

Study Start

April 25, 2017

Primary Completion

August 25, 2017

Study Completion

August 30, 2017

Last Updated

April 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

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