Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in South Asian Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898206
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Bailey, University of Bedfordshire

Brief Summary:
The purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for Type 2 diabetes and heart disease. This study will compare these responses in normal weight versus overweight/obese South Asian adults.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Cardiovascular Diseases Diabetes Physical Activity Sedentary Lifestyle Other: Breaking up sitting with walking breaks Other: Prolonged sitting Not Applicable

Detailed Description:

Participants will attend a preliminary testing session where height, weight, body fat and waist circumference will be measured. They will be familiarised with a motorised treadmill that will be used during the experimental visit below and will take part in an exercise test to determine a light-intensity walking speed for the experimental visit.

Participants will then attend two experimental visits in a random order:

  1. Prolonged sitting: Participants will remain seated for 5 hours and instructed to reduce excessive movement.
  2. Breaking up sitting with walking breaks: Participants will rise from the seated position every 30 minutes throughout the experimental period to walk on a motorised treadmill at a light intensity for 3 minutes. After performing walking activity, they will return to the seated position. In addition, blood sample will be taken at the resting position just before each physical activity bout. The activity breaks will be undertaken on 9 occasions, providing a total of 27 min of light intensity activity.

During each visit, blood pressure will be taken 11 times and blood samples will be taken 10 times. Participants will be given a breakfast and lunch meal to consume.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of Breaking up Prolonged Sitting on Postprandial Cardiometabolic Disease Risk Markers in Normal Weight Versus Overweight and Obese South Asian Adults
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : October 25, 2019
Estimated Study Completion Date : February 25, 2020

Arm Intervention/treatment
Experimental: Prolonged sitting
Participants will remain seated for 5 h and instructed to reduce excessive movement, only rising from the chair to void.
Other: Prolonged sitting
See Prolonged sitting arm description

Experimental: Breaking up sitting with walking breaks
Participants will rise from the seated position every 30 min throughout the experimental period to walk on a motorised treadmill at a light intensity walking (as determined during the preliminary test) for 3 min. Participants will start walk on a treadmill at 30 min (so physical activity would be at 30-33 min), 60 min (physical activity will be at 60-63 min), 90 min (physical activity will be at 90-93 min), 120 min (physical activity will be 120-123 min), 150 min (physical activity will be at 150-153 min ), and 180 min (physical activity will be at 180-183 min) in the breakfast postprandial period and 30 min (physical activity will be 30-33 min), 60 min (physical activity will be at 60-63 min), and 90 min (physical activity will be at 90-93 min) in the lunch postprandial period. After performing walking activity, they will return to the seated position.
Other: Breaking up sitting with walking breaks
See Breaking up sitting with walking breaks arm description




Primary Outcome Measures :
  1. Postprandial glucose [ Time Frame: Measured over the 5 hour condition period ]
    Net incremental area under the curve for each 5 h condition will be calculated for glucose


Secondary Outcome Measures :
  1. Postprandial triglycerides [ Time Frame: Measured over the 5 hour condition period ]
    Net incremental area under the curve for each 5 h condition will be calculated for triglycerides

  2. Postprandial insulin [ Time Frame: Measured over the 5 hour condition period ]
    Net incremental area under the curve for each 5 h condition will be calculated for insulin

  3. Blood pressure [ Time Frame: Measured over the 5 hour condition period ]
    Mean systolic and diastolic blood pressure over the 5 h conditions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identified South Asian ethnicity.
  • Self-report sitting at least 7 hours per day.
  • Normal weight, overweight or obese.

Exclusion Criteria:

  • Unable to speak and read English.
  • Contraindications to performing light-intensity walking.
  • Diagnosed cardiovascular disease or diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898206


Locations
Layout table for location information
United Kingdom
University of Bedfordshire Recruiting
Bedford, Bedfordshire, United Kingdom, MK41 9EA
Contact: Daniel Bailey, PhD    01234793237    daniel.bailey@beds.ac.uk   
Sponsors and Collaborators
University of Bedfordshire

Layout table for additonal information
Responsible Party: Daniel Bailey, Senior Lecturer in Health, Nutrition and Exercise, University of Bedfordshire
ClinicalTrials.gov Identifier: NCT03898206     History of Changes
Other Study ID Numbers: 2019ISPAR003
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases