Effects of Substituting Sitting With Standing and Light Intensity Activity in Free-living Conditions on Glycaemia in Overweight and Obese South Asian Adults

November 25, 2020 updated by: KAMALESH DEY, University of Bedfordshire
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Sit regimen
See Sit regimen arm description
EXPERIMENTAL: 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.
Other: SitLess regimen
See SitLess regimen arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycaemia
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bedfordshire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2020

Primary Completion (ANTICIPATED)

January 31, 2021

Study Completion (ANTICIPATED)

February 28, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (ACTUAL)

November 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020ISPAR006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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