Time to Move in Pregnancy Hyperglycemia

Physical Activity Clinical Trial

— TtM  

Official title:

The Time to Move Randomized Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125704
• Other study ID #: TtM
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: The University of Tennessee, Knoxville
• Contact: Samantha Ehrlich, PhD
• Phone: ?(865) 315-7880?
• Email: sehrlic1[@]utk.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 afternoon/evening (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.

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 walking/stepping (e.g., 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 (i.e., for 1 morning PA day, 1 late afternoon/evening PA day, and 1 no PA day, with the days randomly selected).

5. Complete electronic REDCap surveys, including daily surveys that assess: when (i.e., the exact times) they started eating breakfast, lunch, and dinner that day; when (e.g., 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 (e.g., CGM); and mood state following PA (on days assigned 30 minutes of walking/stepping).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Eligibility Criteria

• Singleton, viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy

• Age 18-40 years (at recruitment)

• Comfortable communicating with study staff in English and completing study surveys in English (i.e., no translator needed)

• Identified as Gestational Glucose Intolerance (GGI) and a 3-hr 100g OGTT for Gestational Diabetes Mellitus (GDM) performed = 24 weeks (i.e., GGI or GDM), or GDM by the one step procedure or a 1-hr 50-g glucose challenge test (GCT) = 180 mg/dl performed = 24 weeks

Identification of GGI 1-hr 50-g GCT (non-fasting), with plasma glucose at 1-hr = 130 mg/dL

Identification of GDM by the two-step procedure

Identified as GGI, followed by a 3-hr 100g OGTT at = 24 weeks after an overnight fast, with at least two of four plasma glucose values meeting or exceeding:

• Fasting: 95 mg/dL

• 1-hr: 180 mg/dL

• 2-hr: 155 mg/dL

• 3-hr: 140 mg/dl

Identification of GDM by the one-step procedure 75-g OGTT at = 24 weeks after an overnight fast, with at least one plasma glucose value meeting or exceeding:

• Fasting: 92 mg/dL

• 1-hr: 180 mg/dL

• 2-hr: 153 mg/dL

Identification of GDM by 1-hr 50-g GCT

1-hr 50-g GLT (non-fasting), with plasma glucose at 1-hr = 180 mg/dL at = 24 weeks

Exclusion Criteria

• Indication that physical activity is or should be limited in the current pregnancy

• Previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of pregnancy

• Current use of daily medications known to alter insulin resistance and/or metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics)

• Current use of medication for polycystic ovarian syndrome (PCOS) (i.e., history of PCOS okay as long as she is not currently taking medication for PCOS)

• Condition or circumstance that would preclude their ability to follow a strict, time-based study protocol (e.g., psychiatric illness).

Related Conditions & MeSH terms

• Circadian Rhythm
• Exercise
• GDM
• Glucose Intolerance
• Hyperglycemia
• Physical Activity

Intervention

Behavioral:
• Moderate intensity walking or stepping
30 minutes of moderate intensity walking or stepping (i.e., at a pace of approximately 100 steps per minute), varied by time of day it is performed: morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) versus late afternoon/evening (i.e., between 4pm-8pm, within 30-40 minutes of dinner).

Locations

Country	Name	City	State
United States	The University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	University of Tennessee Graduate School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM glucose outcomes	Glucose outcome measures include: 24-hour glucose and coefficient of variation, daytime glucose, nighttime glucose, pre-breakfast area under the glucose curve (AUC; calculated for the 120 minutes prior to the start of breakfast), and all post-meal AUCs (calculated for the 120 minutes after the start of the breakfast, lunch and dinner).	Throughout the 11-day study period
Secondary	Duration of sleep	Self-reported length of each sleep period (in hours: minutes)	Throughout the 11-day study period
Secondary	Sleep efficiency	Self-reported percentage of time spent asleep while in bed (0-100%), for each sleep period	Throughout the 11-day study period
Secondary	Sleep quality	Self-reported quality of sleep (i.e., very poor, poor, fair, good, or very good), for each sleep period	Throughout the 11-day study period
Secondary	Mood	Mood following physical activity, using the short version of the Multi-Dimensional Mood Questionnaire (MDMQ, with 15 items) which measures self-reported mood states (i.e., scores range from 15-90, with higher scores indicating better mood state).	Throughout the 11-day study period (i.e., on days assigned to physical activity)