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Pre DiabetesNCT04144920

Evaluating the Acute Glycemic Response to Different Strategies of Breaking Up Sedentary Time

A study testing CS: Continuous sitting, HFLD: HIgh frequency, low duration standing breaks and LFHD: Low frequency, high duration standing breaks in people with Pre Diabetes and Postprandial Hyperglycemia, run by Arizona State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Pre Diabetes, Postprandial Hyperglycemia
What is being tested?
CS: Continuous sitting, HFLD: HIgh frequency, low duration standing breaks and LFHD: Low frequency, high duration standing breaks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Aug 2018to 14 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Arizona State University

    Tempe, Arizona, 85281

Other trials in United States

About this study

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.

Read the detailed description

Most studies that explored the health benefits of interrupting sitting time focused on using different modalities (i.e., comparing walking vs standing breaks). However, experimental studies that directly compare patterns of interrupting sitting time through standing only are needed to advance the field. This study aimed to (i) determine if there is a difference in glucose response between continuous sitting (CS) and two intermittent standing regimes (high frequency, low duration breaks (HFLD) and low frequency, high duration breaks (LFHD)) and (ii) to determine if there is a difference in glucose response between the two strategies (HFLD vs. LFHD).

  1. Study Participants and Recruitment The target participants were sedentary office employees with impaired fasting glucose level. Participants were recruited through a study flyer via various recruitment channels (i.e., ASU faculty website, social media, word of mouth). The study flyer contains a link to a Qualtrics survey to pre-screen interested participants. All eligible participants will be scheduled for a 30-minute screening visit to assess fasting glucose level. A total of 12 sedentary and inactive employees (indicated by >6 hrs of workplace sedentary time assessed by the activPAL device during a one-week screening period) will be enrolled to participate in a fully randomized crossover trial.
  2. Study Design 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. In the interrupted sitting conditions (i.e., HFLD and LFHD), total sitting and standing time were designed to be equal in both groups. The only difference between the two conditions was on the pattern to accumulate sitting time. A common threshold for prolonged sitting time in epidemiological studies of sedentary behavior is 30 minutes of continuous sitting. In the HFLD condition, we will use half of this threshold and ask participants to interrupt their sitting time every 15 minutes using a 2.5-minute standing break. In contrast, participants will perform twice this threshold in the LFHD standing breaks where they will complete a 10-minute standing break every hour of sitting.

All possible sequence of condition were determined and organized into blocks (a total of six blocks). Each eligible participant will be randomly assigned to a block to determine the sequence that they would perform the conditions. The randomization process will involve a separate research staff preparing 40 sealed envelope that contains a block number randomly determined using a computer-generated random sequence. These envelopes will be kept in a secure cabinet by another research staff not directly involved in the project. Each participant will be blinded to the condition that they are going to perform during the visit until after their first standardized meal.

Participants will be invited to three 450-minute (7.5-hour) laboratory visits where they will be provided with a private room, a sit-stand workstation, and a desktop computer. During each laboratory visit, participants will perform their usual desk-based work activities. All visits will be scheduled one week apart. Participants will be instructed to fast overnight, and standardized breakfast and lunch meals will also be provided to control for any dietary effects on glucose level. In addition, each participant will be instructed to avoid any moderate-vigorous physical activities for at least two days and smoking cigarettes and consuming alcoholic beverages at least three days prior to each visit. Upon arrival to the lab for their first visit, participants will complete a dietary log of their last meal the previous day. They will then be instructed to replicate this meal the night prior to each visit.

  1. Outcome Measures Continuous Glucose Monitors. A day prior to the first visit, participants will be fitted with a Freestyle Libre Pro (Abbott Laboratories, Chicago, IL) continuous glucose monitor by a trained researcher. The sensor will be attached to the back part of the participant's non-dominant arm and programmed to measure interstitial glucose at 15-minute intervals. The device is designed to be worn continuously for 14 days and is waterproof, lightweight (roughly the size of a quarter) and minimally obtrusive. The sensors will be attached using proper aseptic procedures and in accordance with the manufacturer's instructions. Lastly, each participant will be given instructions on how to care for the device.

At the end of the last visit, data from each sensor will be acquired using the Libre Pro reader and uploaded to an online patient repository (LibreView). Data will then be processed, and 15-minute epoch data will be downloaded into a local secure drive for further processing. Continuous glucose data corresponding to each visit date and time will be isolated using the paper logs and inspected for completeness and quality of data. Files with less than 80% of valid observation will be excluded from the succeeding analyses. Glucose incremental area under the curve (iAUC) will be calculated using the trapezoidal method along with other metrics for variability (i.e., MAGE: mean amplitude of glycemic excursions).

activPAL Device. Objective measures of sitting, standing and moving time will derived from the activPAL micro accelerometer worn on the midline of the right thigh. Participants will wear the device on two occasions: (i) for 7 consecutive days during the baseline period and (ii) for 14 consecutive days during the study. The validity and reliability of the activPAL in measuring sedentary and physical activity behaviors has been previously reported. Collected data will be processed into events of sitting, standing, or moving (i.e., stepping) using the activPAL software version 7.2.32 (PAL Technologies Ltd, Scotland, UK).

Standard Meals. Standardized meals (breakfast and lunch) will be provided in each lab visit to control for any dietary influence. Each meal are designed to provide 33% of the participant's total daily caloric needs following a typical American diet (50-60% carbohydrates, 25-35% fat, and 10-20% protein). Basal metabolic rate will be calculated for each particiapnt using Schofield's equation using a 1.5 activity factor. After calculating the required caloric content of each meal, a meal with the closest caloric value will be chosen from a list of pre-determined meal plan. A typical breakfast will be composed of a croissant, ham, cheddar cheese, cereals with milk, fruit cup, and orange juice while lunch items consisted of a ciabatta ham and cheese sandwich and orange juice. The same meal will be provided during all follow-up visits.

Being tested
CS: Continuous sitting, HFLD: HIgh frequency, low duration standing breaks, LFHD: Low frequency, high duration standing breaks
Keywords
Interrupting sitting, Continuous glucose monitroing, Pattern of sitting breaks
Medical subject headings
Glucose Intolerance, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CS: Continuous sittingBehavioural

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

  • HFLD: HIgh frequency, low duration standing breaksBehavioural

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

  • LFHD: Low frequency, high duration standing breaksBehavioural

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

Study groups in NCT04144920
Study groupRoleWhat they receive
Block 1OtherParticipants in this arm performed the conditions in this order: CS, HFLD, LFHD
Receives: Behavioral: CS: Continuous sitting; Behavioral: HFLD: HIgh frequency, low duration standing breaks; Behavioral: LFHD: Low frequency, high duration standing breaks
Block 2OtherParticipants in this arm performed the conditions in this order: CS, LFHD, HFLD
Receives: Behavioral: CS: Continuous sitting; Behavioral: HFLD: HIgh frequency, low duration standing breaks; Behavioral: LFHD: Low frequency, high duration standing breaks
Block 3OtherParticipants in this arm performed the conditions in this order: HFLD, CS, LFHD
Receives: Behavioral: CS: Continuous sitting; Behavioral: HFLD: HIgh frequency, low duration standing breaks; Behavioral: LFHD: Low frequency, high duration standing breaks
Block 4OtherParticipants in this arm performed the conditions in this order: HFLD, LFHD, CS
Receives: Behavioral: CS: Continuous sitting; Behavioral: HFLD: HIgh frequency, low duration standing breaks; Behavioral: LFHD: Low frequency, high duration standing breaks
Block 5OtherParticipants in this arm performed the conditions in this order: LFHD, CS, HFLD
Receives: Behavioral: CS: Continuous sitting; Behavioral: HFLD: HIgh frequency, low duration standing breaks; Behavioral: LFHD: Low frequency, high duration standing breaks
Block 6OtherParticipants in this arm performed the conditions in this order: LFHD, HFLD, CS
Receives: Behavioral: CS: Continuous sitting; Behavioral: HFLD: HIgh frequency, low duration standing breaks; Behavioral: LFHD: Low frequency, high duration standing breaks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprandial glucose incremental area under the curve (iAUC)

    iAUC will be calculated using the trapezoidal method.

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

  2. Mean postprandial glucose

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

  3. Glucose variability (mean amplitude glycemic excursions)

    Measured: total lab time (7 hrs)

Secondary outcomes (1)
  1. Physical and Emotional feeling states

    Self-report (via EMA) measures of fatigue, stress, busyness, hunger, and affective states

    Measured: total lab time (7 hrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2019
  2. Study start1 Aug 2018
  3. Primary completion14 Jun 2019
  4. Study completion14 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04144920
Sponsor's protocol ID
STUDY00008450
Status last verified
Oct 2019
First submitted
28 Oct 2019
Last updated
30 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing CS: Continuous sitting, HFLD: HIgh frequency, low duration standing breaks and LFHD: Low frequency, high duration standing breaks in people with Pre Diabetes and Postprandial Hyperglycemia, run by Arizona State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial glucose incremental area under the curve (iAUC) (time frame: post breakfast (3.5 hrs), post lunch (3.5 hrs), and total lab time (7 hrs)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.

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