NCT04144920

Brief Summary

This study aims to determine the most effective strategy of reducing sedentary behavior to improve health. Specifically, we aim to answer the following questions: (a) To determine if there is a significant difference in acute post-prandial glucose response between continuous sitting and two intermittent standing regimes (high frequency, low duration breaks (HFLD) and low frequency, high duration breaks (LFHD)). We hypothesize that intermittent standing (combined HFLD breaks and LFHD breaks regimes) will result in lower overall acute post-prandial glucose compared to continuous sitting. (b) To determine if there is a significant difference in acute post-prandial glucose response between two strategies to reduce sitting with standing (HFLD standing breaks vs. LFHD standing breaks). We hypothesize that the HFLD breaks condition will elicit lower acute post-prandial glucose level compared to the LFHD breaks condition. All eligible participants will be consented and subjected to all three study conditions: (i) Uninterrupted sitting, (ii) HFLD breaks, and (iii) LFHD breaks. The order at which participants were subjected to these conditions will be randomly determined and each condition were performed a week apart. Standardized meals (breakfast and lunch) will be provided during each lab visit and participants will be then be asked to perform their usual work activity using a sit-stand workstation in the lab. Depending on their assigned condition, the participants will be prompted to stand or sit for a given period of time. A continuous glucose monitor will be used to measure glucose response to the intervention while an activPAL device will be used to make sure that participants are compliant with the study protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

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

Study Start

First participant enrolled

August 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 28, 2019

Last Update Submit

October 28, 2019

Conditions

Keywords

Interrupting sittingContinuous glucose monitroingPattern of sitting breaks

Outcome Measures

Primary Outcomes (3)

  • Postprandial glucose incremental area under the curve (iAUC)

    iAUC will be calculated using the trapezoidal method.

    post breakfast (3.5 hrs), post lunch (3.5 hrs), and total lab time (7 hrs)

  • Mean postprandial glucose

    post breakfast (3.5 hrs), post lunch (3.5 hrs), and total lab time (7 hrs)

  • Glucose variability (mean amplitude glycemic excursions)

    total lab time (7 hrs)

Secondary Outcomes (1)

  • Physical and Emotional feeling states

    total lab time (7 hrs)

Study Arms (6)

Block 1

OTHER

Participants in this arm performed the conditions in this order: CS, HFLD, LFHD

Behavioral: CS: Continuous sittingBehavioral: HFLD: HIgh frequency, low duration standing breaksBehavioral: LFHD: Low frequency, high duration standing breaks

Block 2

OTHER

Participants in this arm performed the conditions in this order: CS, LFHD, HFLD

Behavioral: CS: Continuous sittingBehavioral: HFLD: HIgh frequency, low duration standing breaksBehavioral: LFHD: Low frequency, high duration standing breaks

Block 3

OTHER

Participants in this arm performed the conditions in this order: HFLD, CS, LFHD

Behavioral: CS: Continuous sittingBehavioral: HFLD: HIgh frequency, low duration standing breaksBehavioral: LFHD: Low frequency, high duration standing breaks

Block 4

OTHER

Participants in this arm performed the conditions in this order: HFLD, LFHD, CS

Behavioral: CS: Continuous sittingBehavioral: HFLD: HIgh frequency, low duration standing breaksBehavioral: LFHD: Low frequency, high duration standing breaks

Block 5

OTHER

Participants in this arm performed the conditions in this order: LFHD, CS, HFLD

Behavioral: CS: Continuous sittingBehavioral: HFLD: HIgh frequency, low duration standing breaksBehavioral: LFHD: Low frequency, high duration standing breaks

Block 6

OTHER

Participants in this arm performed the conditions in this order: LFHD, HFLD, CS

Behavioral: CS: Continuous sittingBehavioral: HFLD: HIgh frequency, low duration standing breaksBehavioral: LFHD: Low frequency, high duration standing breaks

Interventions

Participants were asked to sit continuously throughout the duration of the lab visit.

Block 1Block 2Block 3Block 4Block 5Block 6

Participants were asked to interrupt their sitting time every 15 minutes using 2.5-minute standing breaks.

Block 1Block 2Block 3Block 4Block 5Block 6

Participants were asked to interrupt their sitting time every 60 minutes using 10-minute standing breaks.

Block 1Block 2Block 3Block 4Block 5Block 6

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (i) ages 35-65 years, (ii) sedentary work habits, (iii) presence of impaired fasting glucose (fasting glucose level of 100-125 mg/dL), (iv) willing to engage in three 7.5 hour lab visit, (v) willing to wear the activPAL and continuous glucose monitor, (vii) current sit-stand workstation owner, and (viii) BMI 25-45 kg/m2

You may not qualify if:

  • (i) chronic mobility limitations, such as moderate-to-severe arthritis, (ii) psychiatric disorders, (iii) cardiometabolic abnormality, (iv) food allergy/restriction, (v) BMI\>45 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Tempe, Arizona, 85281, United States

Location

MeSH Terms

Conditions

Glucose IntoleranceHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded on what protocol they will be performing until after their first standardized meal.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The study design is a crossover randomized trial with three conditions: (i) uninterrupted sitting, (ii) high-frequency and low duration (HFLD) standing breaks, and (iii) low-frequency and high duration (LFHD) standing breaks. We utilized a balanced and uniform with 6 randomization blocks (ABC, ACB, BAC,BCA, CAB, CBA) design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

August 1, 2018

Primary Completion

June 14, 2019

Study Completion

June 14, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations