Time to Move in Pregnancy Hyperglycemia
The Time to Move Randomized Crossover Trial
The University of Tennessee, Knoxville
36 participants
Dec 6, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria18
- 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
- -hr: 180 mg/dL
- -hr: 155 mg/dL
- -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
- -hr: 180 mg/dL
- -hr: 153 mg/dL
- Identification of GDM by 1-hr 50-g GCT
- -hr 50-g GLT (non-fasting), with plasma glucose at 1-hr ≥ 180 mg/dL at ≥ 24 weeks
Exclusion Criteria5
- 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).
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Interventions
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(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06125704