Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125704
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-10-30
Brief Title:
Time to Move in Pregnancy Hyperglycemia
Sponsor:
The University of Tennessee Knoxville
Organization:
The University of Tennessee Knoxville
Study Overview
Official Title:
The Time to Move Randomized Crossover Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TtM
Brief Summary:
This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes GDM or gestational glucose intolerance GGI will
1 Determine the effects of physical activity PA timing specifically 30 minutes of moderate intensity walking or stepping in the morning between 5am-9am within 30-40 minutes of starting breakfast versus late afternoonevening between 4pm-8pm within 30-40 minutes of dinner on glucose across the 24-hour cycle
2 Explore the potential effects of the timing of PA on sleep and mood state
1 Determine the effects of physical activity PA timing specifically 30 minutes of moderate intensity walking or stepping in the morning between 5am-9am within 30-40 minutes of starting breakfast versus late afternoonevening between 4pm-8pm within 30-40 minutes of dinner on glucose across the 24-hour cycle
2 Explore the potential effects of the timing of PA on sleep and mood state
Detailed Description:
Research participants will
1 Exercise according to a schedule provided by the study for an 11-day period They will complete either no exercise or 30 minutes of walkingstepping eg stepping in place or around the house when walking outside is not an option or not an attractive option on specifically assigned days at specifically assigned times of day
2 Wear a masked Dexcom G6 continuous glucose monitor CGM for the 11-day study period
3 Wear a masked physical activity PA monitor watch ActiGraph CentrePoint Insight Watch on the non-dominant wrist for the 11-day study period all day and all night
4 Take pictures of all of food and drinks consumed at the start and end showing food and drink not eaten of all eating occasions Participants will use their phones to upload photos to a study website for the entire 11-day study period Participants will also complete 24-hour dietary recall phone calls for 3 of the 11 study days ie for 1 morning PA day 1 late afternoonevening PA day and 1 no PA day with the days randomly selected
5 Complete electronic REDCap surveys including daily surveys that assess when ie the exact times they started eating breakfast lunch and dinner that day when eg the exact times they went to bed and fell asleep for the night and woke up and got out of bed the next morning and questions on the quality of their sleep adverse events and issues with the study equipment eg CGM and mood state following PA on days assigned 30 minutes of walkingstepping
1 Exercise according to a schedule provided by the study for an 11-day period They will complete either no exercise or 30 minutes of walkingstepping eg stepping in place or around the house when walking outside is not an option or not an attractive option on specifically assigned days at specifically assigned times of day
2 Wear a masked Dexcom G6 continuous glucose monitor CGM for the 11-day study period
3 Wear a masked physical activity PA monitor watch ActiGraph CentrePoint Insight Watch on the non-dominant wrist for the 11-day study period all day and all night
4 Take pictures of all of food and drinks consumed at the start and end showing food and drink not eaten of all eating occasions Participants will use their phones to upload photos to a study website for the entire 11-day study period Participants will also complete 24-hour dietary recall phone calls for 3 of the 11 study days ie for 1 morning PA day 1 late afternoonevening PA day and 1 no PA day with the days randomly selected
5 Complete electronic REDCap surveys including daily surveys that assess when ie the exact times they started eating breakfast lunch and dinner that day when eg the exact times they went to bed and fell asleep for the night and woke up and got out of bed the next morning and questions on the quality of their sleep adverse events and issues with the study equipment eg CGM and mood state following PA on days assigned 30 minutes of walkingstepping
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None