NCT03898206

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

March 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

April 26, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

March 28, 2019

Results QC Date

September 3, 2025

Last Update Submit

April 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postprandial Glucose

    Incremental area under the curve for each 5 h condition will be calculated for glucose

    Measured over the 5 hour condition period

Secondary Outcomes (8)

  • Postprandial Triglycerides

    Measured over the 5 hour condition period

  • Postprandial Insulin

    Measured over the 5 hour condition period

  • Metabolic Load Index

    Measured over the 5 hour condition period

  • Resting Energy Expenditure

    Measured for the 5 hour condition period

  • Resting Fat Oxidation

    Measured for the 5 hour condition period

  • +3 more secondary outcomes

Study Arms (2)

Prolonged sitting (SIT), then breaking up sitting with walking breaks (INT-SIT)

EXPERIMENTAL

Firstly, participants will remain seated for 5 h and instructed to reduce excessive movement, only rising from the chair to void. After a washout period of at least 3 days, they then performed the INT-SIT condition. Prolonged sitting (SIT): See SIT arm description Breaking up sitting with walking breaks (INT-SIT): See INT-SIT arm description

Other: Prolonged sitting (SIT)

Breaking up sitting with walking breaks (INT-SIT), then prolonged sitting (SIT)

EXPERIMENTAL

Firstly, 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 5 min. Participants will start walk on a treadmill at 30 min (so physical activity would be at 30-35 min), 60 min (physical activity will be at 60-65 min), 90 min (physical activity will be at 90-95 min), 120 min (physical activity will be 120-125 min), 150 min (physical activity will be at 150-155 min ), and 180 min (physical activity will be at 180-185 min) in the breakfast postprandial period and 30 min (physical activity will be 30-35 min), 60 min (physical activity will be at 60-65 min), and 90 min (physical activity will be at 90-95 min) in the lunch postprandial period. After performing a walking activity, they will return to the seated position. After a washout period of at least 3 days, they then performed the SIT condition. SIT : See SIT arm description

Other: Breaking up sitting with walking breaks (INT-SIT)

Interventions

See Breaking up sitting with walking breaks arm description

Breaking up sitting with walking breaks (INT-SIT), then prolonged sitting (SIT)

See Prolonged sitting arm description

Prolonged sitting (SIT), then breaking up sitting with walking breaks (INT-SIT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bedfordshire

Bedford, Bedfordshire, MK41 9EA, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Results Point of Contact

Title
Dr Kamalesh Dey
Organization
University of Bedfordshire

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Sedentary Behaviour and Health

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 1, 2019

Study Start

April 26, 2019

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

April 21, 2026

Results First Posted

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations