Evaluating the Acute Glycemic Response to Different Strategies of Breaking Up Sedentary Time
1 other identifier
interventional
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedFirst Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedOctober 30, 2019
October 1, 2019
11 months
October 28, 2019
October 28, 2019
Conditions
Keywords
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
OTHERParticipants in this arm performed the conditions in this order: CS, HFLD, LFHD
Block 2
OTHERParticipants in this arm performed the conditions in this order: CS, LFHD, HFLD
Block 3
OTHERParticipants in this arm performed the conditions in this order: HFLD, CS, LFHD
Block 4
OTHERParticipants in this arm performed the conditions in this order: HFLD, LFHD, CS
Block 5
OTHERParticipants in this arm performed the conditions in this order: LFHD, CS, HFLD
Block 6
OTHERParticipants in this arm performed the conditions in this order: LFHD, HFLD, CS
Interventions
Participants were asked to sit continuously throughout the duration of the lab visit.
Participants were asked to interrupt their sitting time every 15 minutes using 2.5-minute standing breaks.
Participants were asked to interrupt their sitting time every 60 minutes using 10-minute standing breaks.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- 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