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| Name | Class |
|---|---|
| University of Tennessee Graduate School of Medicine | OTHER |
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This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will:
Research participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning physical activity first | Other | Randomized to complete 30 minute of moderate intensity walking or stepping in the morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) on days 4 and 5, and 30 minute of moderate intensity walking or stepping in the late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on days 9 and 10. |
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| Afternoon/evening physical activity first | Other | Randomized to complete 30 minute of moderate intensity walking or stepping in the late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on days 4 and 5, and 30 minute of moderate intensity walking or stepping in the morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) on days 9 and 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate intensity walking or stepping | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sleep | Self-reported length of each sleep period (in hours: minutes) | Throughout the 11-day study period |
| Sleep efficiency | Self-reported percentage of time spent asleep while in bed (0-100%), for each sleep period |
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Eligibility Criteria
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Samantha Ehrlich, PhD | The University of Tennessee, Knoxville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41607684 | Derived | Ehrlich SF, Hallenbeck BR, Lewis J, Yousefi F, Miller JI, Zite NB, Fortner KB, Schoutko WW, Crouter SE, Raynor H, Maples JM. Rationale and protocol for the Time to Move Randomized Crossover Trial: morning versus evening time physical activity and CGM-assessed glucose levels in individuals with pregnancy hyperglycemia. Front Clin Diabetes Healthc. 2026 Jan 13;6:1709683. doi: 10.3389/fcdhc.2025.1709683. eCollection 2025. | |
| 41321483 |
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Yes: all IPD that underlie published results and related data dictionaries available.
Data will become available starting 6 months after publication and be available for 3 years.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Dr. Samantha Ehrlich at sehrlic1@utk.edu
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D006943 | Hyperglycemia |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Throughout the 11-day study period |
| 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 |
| 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) |
| Derived |
| Ehrlich SF, Hallenbeck BR, Zite NB, Fortner KB, Paudel A, Raynor HA, Crouter SE, Maples JM. A Randomized Controlled Pilot Trial of a Behavioral Physical Activity Intervention for Pregnancy Hyperglycemia. J Pregnancy. 2025 Nov 20;2025:7485092. doi: 10.1155/jp/7485092. eCollection 2025. |