Effects of Substituting Sitting With Standing and Light Intensity Activity in Free-living Conditions on Glycaemia in Overweight and Obese South Asian Adults
Primary Purpose
Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sit regimen
SitLess regimen
Sponsored by
About this trial
This is an interventional basic science trial for Cardiovascular Risk Factor
Eligibility Criteria
Inclusion Criteria:
- Self-identified South Asian ethnicity.
- Self-report sitting at least 7 hours per day.
- Overweight or obese
Exclusion Criteria:
- Unable to speak and read English.
- Not able to performing light-intensity activities.
- Diagnosed cardiovascular disease or diabetes.
Sites / Locations
- University of BedfordshireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sit regimen
SitLess regimen
Arm Description
Participants will be instructed to restrict walking and standing to ≤1 h/day each (total ≤2 h/day ) and the remainder of the waking day will be seated apart from visiting the toilet.
Participants will be instructed to substitute a minimum of 5h/day of sitting with ≥2 h of light-intensity physical activity and ≥3 h of standing. Participants will be advised to rise from the seated position for 2-5 min every 30 min to engage in standing /light-intensity physical activities to interrupt their sitting.
Outcomes
Primary Outcome Measures
Glycaemia
Net incremental area under the curve for each 4-day condition will be measured in the interstitial fluid of the subcutaneous tissue every minute and data averaged for each 15-min period will be stored and transmitted to a reader. The reader will be downloaded by the research team at the end of the last condition day.
Secondary Outcome Measures
Full Information
NCT ID
NCT04645875
First Posted
November 19, 2020
Last Updated
November 25, 2020
Sponsor
University of Bedfordshire
1. Study Identification
Unique Protocol Identification Number
NCT04645875
Brief Title
Effects of Substituting Sitting With Standing and Light Intensity Activity in Free-living Conditions on Glycaemia in Overweight and Obese South Asian Adults
Official Title
Effects of Substituting Sitting With Standing and Light Intensity Activity in Free-living Conditions on Glycaemia in Overweight and Obese South Asian Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bedfordshire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine whether substituting sitting with standing and light-intensity activity in free-living conditions can reduce glycaemia in overweight/obese South Asian adults.
Detailed Description
Anthropometric measurement tools including a stadiometer, a measurement tape and digital weighing scale, activity monitor and Flash Glucose Monitor and sensor will be posted to the participants' home or workplace or research team drop all these items to participants' doorstep to allow participants to take their measures including height, weight, and waist circumference.
Every participant will have to perform a try-out day of the SitLess regimen for 24 hours before starting the study and it will be performed after preliminary testing and before the first experimental condition. Those participants will be included for this study who will be able to adhere to the protocol based on a review of the activPAL activity monitor data that will be worn during the day. Additionally, a second attempt will be offered to them to adhere to the protocol if needed.
Participants will undertake two separate activity regimens in free-living conditions which will be lasting 4-day each condition in a random order:
# Sit regimen: Participants will be instructed to restrict walking and standing to ≤1 h/day each (total ≤2 h/day ) and the remainder of the waking day will be seated apart from visiting the toilet. They will be allowed to perform their daily activities including cooking and other household activities within the 2 h of permitted walking and standing.
#SitLess regimen: Participants will be instructed to substitute a minimum of 5h/day of sitting with ≥2 h of light-intensity physical activity and ≥3 h of standing. Participants will be advised to rise from the seated position for 2-5 min every 30 min to engage in standing /light-intensity physical activities to interrupt their sitting.
During each activity regimen, participants will be asked to record all of the activities in an activity logbook. In addition, they will be asked to weigh (using kitchen scales) and record food and beverage consumption in a diary for the first four days (days 1-4) and then replicate the dietary intakes and timings exactly for the second four days (days 8-11). They will need to make sure that each meal contains at least 50% carbohydrate. Kitchen scales and a food diary will be provided by the research team.
Throughout the 11 days, participants will be required to avoid alcohol consumption and performing exercise (e.g. brisk walking, sports, going to the gym, cycling, running etc).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Cardiovascular Diseases, Diabetes, Type 2 Diabetes, Sedentary Behavior, Sedentary Lifestyle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sit regimen
Arm Type
Experimental
Arm Description
Participants will be instructed to restrict walking and standing to ≤1 h/day each (total ≤2 h/day ) and the remainder of the waking day will be seated apart from visiting the toilet.
Arm Title
SitLess regimen
Arm Type
Experimental
Arm Description
Participants will be instructed to substitute a minimum of 5h/day of sitting with ≥2 h of light-intensity physical activity and ≥3 h of standing. Participants will be advised to rise from the seated position for 2-5 min every 30 min to engage in standing /light-intensity physical activities to interrupt their sitting.
Intervention Type
Other
Intervention Name(s)
Sit regimen
Intervention Description
See Sit regimen arm description
Intervention Type
Other
Intervention Name(s)
SitLess regimen
Intervention Description
See SitLess regimen arm description
Primary Outcome Measure Information:
Title
Glycaemia
Description
Net incremental area under the curve for each 4-day condition will be measured in the interstitial fluid of the subcutaneous tissue every minute and data averaged for each 15-min period will be stored and transmitted to a reader. The reader will be downloaded by the research team at the end of the last condition day.
Time Frame
Net incremental area under the curve for interstitial glucose concentration during each 4-day condition will be calculated (i.e., the time frame is during the intervention)
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Self-identified South Asian ethnicity.
Self-report sitting at least 7 hours per day.
Overweight or obese
Exclusion Criteria:
Unable to speak and read English.
Not able to performing light-intensity activities.
Diagnosed cardiovascular disease or diabetes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamalesh Dey, MPH
Phone
07574748607
Email
kamalesh.dey@study.beds.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Fruer, PhD
Phone
01234 793410
Email
julia.fruer@beds.ac.uk
Facility Information:
Facility Name
University of Bedfordshire
City
Bedford
State/Province
Bedfordhsire
ZIP/Postal Code
MK41 9EA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamalesh Dey, MPH
Phone
07574748607
Email
kamalesh.dey@study.beds.ac.uk
First Name & Middle Initial & Last Name & Degree
Julia Fruer, PhD
Phone
01234 793410
Email
julia.fruer@beds.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Substituting Sitting With Standing and Light Intensity Activity in Free-living Conditions on Glycaemia in Overweight and Obese South Asian Adults
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