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The goal of this clinical trial is to evaluate the effect of physical activity on glucose control in pregnant patients with pregestational Type 2 diabetes. The main question it seeks to answer is "will physical activity following a meal improve blood sugar control in pregnant women with Type 2 diabetes?" Researchers will compare the glucose control of two groups: one that walks for 20 minutes after each meal, and one that does not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-prandial walk | Active Comparator | Participants in this arm of the study will be instructed to walk for 20 minutes after each meal (breakfast, lunch, and dinner). They will also be given a continuous glucose monitor and a FitBit, to wear throughout their participation in the study. |
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| Standard of Care | No Intervention | Participants in this arm will be given the regular counseling on the importance of exercise during pregnancy, but not instructed to walk after each meal. They will receive a continuous glucose monitor and FitBit to wear throughout their participation in the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | This intervention consists of instructions to walk for 20 minutes after each meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Time in Range | Our primary outcome is the time in range (via CGM data) during the management of Type 2 diabetes in pregnancy between 34 and 36 weeks gestation. | Between 34 and 36 weeks gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postprandial walk | Duration of postprandial walk (in minutes) | From enrollment to delivery, an average of 6 months |
| Sleep duration | Amount of time spent sleeping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwan Ma'ayeh, MD | Contact | 757-446-7900 | MaayehMG@odu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Virginia Medical School, Macon and Joan Brock Virginia Health Sciences at Old Dominion University | Norfolk | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25537714 | Background | American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available. | |
| 19560716 | Background | Colberg SR, Zarrabi L, Bennington L, Nakave A, Thomas Somma C, Swain DP, Sechrist SR. Postprandial walking is better for lowering the glycemic effect of dinner than pre-dinner exercise in type 2 diabetic individuals. J Am Med Dir Assoc. 2009 Jul;10(6):394-7. doi: 10.1016/j.jamda.2009.03.015. Epub 2009 May 21. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2025 | Oct 3, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Experimental Consent Form | Sep 16, 2025 | Nov 18, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Control Consent Form | Sep 16, 2025 | Nov 18, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| From enrollment to delivery, an average of 6 months |
| Baseline heart rate | Heart rate when not exercising | From enrollment to delivery, an average of 6 months |
| Maximal heart rate during walks | Maximal heart rate during postprandial walks | From enrollment to delivery, an average of 6 months |
| Frequency of aerobic exercise per week | Number of times a participant engages in aerobic exercise each week | From enrollment to delivery, an average of 6 months |
| Mean glucose level | Average blood sugar level | From enrollment to delivery, an average of 6 months |
| Blood Glucose Excursions | Changes in blood glucose | From enrollment to delivery, an average of 6 months |
| Fasting blood sugar | Blood sugar following a fast | From enrollment to delivery, an average of 6 months |
| Total daily insulin dose | The total amount of insulin administered to the participant daily | From enrollment to delivery, an average of 6 months |
| Rates of fetal demise | Whether fetal death occurs prior to delivery | From enrollment to delivery, an average of 6 months |
| Rates of fetal growth restriction among participants | When the fetus is considered small for gestational age at any point in pregnancy | From enrollment to delivery, an average of 6 months |
| Rates of preeclampsia among participants | Occurrence of preeclampsia during pregnancy | From enrollment to delivery, an average of 6 months |
| Rates of placental abruption among participants | From enrollment to delivery, an average of 6 months |
| Mode of delivery | Cesarean or vaginal | From enrollment to delivery, an average of 6 months |
| Number of participants with indication for cesarean delivery | From enrollment to delivery, an average of 6 months |
| Presence of shoulder dystocia | Vaginal deliveries | Duration of delivery, up to 72 hours |
| Quantitative blood loss | mL | From onset of labor to hospital discharge, up to 42 days post-delivery |
| Postpartum hemorrhage | Defined as quantitative blood loss >1000 mL | From delivery to hospital discharge, up to 42 days post-delivery |
| Occurrence of Infection | Chorioamnionitis or postpartum endometritis prior to discharge | From delivery to hospital discharge, up to 42 days |
| Neonatal birth weight | Grams | From delivery to hospital discharge, up to 42 days |
| APGAR Scores | Scored from 0-10, with 10 being the best outcome | From delivery to hospital discharge, up to 1 year |
| Incidence of Neonatal Infection | Sepsis, fever, positive cultures, or a suspicious clinical course that warrants antibiotics treatment | From delivery to hospital discharge, up to 1 year |
| Rates of respiratory distress syndrome amongst participant infants | From delivery to hospital discharge, up to 1 year |
| Rates of necrotizing enterocolitis amongst participant infants | From delivery to hospital discharge, up to 1 year |
| Rates Neonatal Intensive Care Unit admission amongst participant infants | From deliver to NICU admission, up to 1 year |
| Days in the NICU | From NICU admission to NICU discharge, up to 1 year |
| Hemoglobin A1c | Blood Hemoglobin A1c level | At time of randomization, up to 32 weeks gestation |
| Hemoglobin A1c | Blood Hemoglobin A1c levels | Between 34 and 36 weeks gestation |
| C-peptide | Blood c-peptide levels | Collected at time of randomization, up to 32 weeks gestation |
| C-peptide | Blood c-peptide levels | Between 34 and 36 weeks gestation |
| Insulin | Blood insulin levels | At time of randomization, up to 32 weeks gestation |
| Insulin | Blood insulin level | Between 34 and 36 weeks gestation |
| Leptin | Blood leptin level | At time of randomization, up to 32 weeks gestation |
| Leptin | Blood leptin level | Between 34 and 36 weeks gestation |
| Adipoleptin | Blood adipoleptin | At time of randomization, up to 32 weeks gestation |
| Adipoleptin | Blood adipoleptin level | Between 34 and 36 weeks gestation |
| Body fat mass | Mass of body fat determined using bioelectrical impedance analysis | At time of randomization, up to 32 weeks gestation |
| Body fat mass | Mass of body fat determined using bioelectrical impedance analysis | Between 34 and 36 weeks gestation |
| Body fat percentage | Body fat percentage determined via bioelectrical impedance analysis | At time of randomization, up to 32 weeks gestation |
| Body fat percentage | Body fat percentage determined via bioelectrical impedance analysis | Between 34 and 36 weeks gestation |
| Fat free mass | Measure of body composition, determined by bioelectrical impedance analysis | Time of randomization, up to 32 weeks |
| Fat free mass | Measure of body composition, determined by bioelectrical impedance analysis | Between 34 and 36 weeks gestation |
| Total body water | Amount of water in the body, determined by bioelectrical impedance analysis | At time of randomization, up to 32 weeks gestation |
| Total body water | Amount of water in the body, determined by bioelectrical impedance analysis | Between 34 and 36 weeks gestation |
| 35985050 | Background | Christie HE, Chang CR, Jardine IR, Francois ME. Three short postmeal walks as an alternate therapy to continuous walking for women with gestational diabetes. Appl Physiol Nutr Metab. 2022 Oct 1;47(10):1031-1037. doi: 10.1139/apnm-2021-0619. Epub 2022 Aug 19. |
| 34216833 | Background | Andersen MB, Fuglsang J, Ostenfeld EB, Poulsen CW, Daugaard M, Ovesen PG. Postprandial interval walking-effect on blood glucose in pregnant women with gestational diabetes. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100440. doi: 10.1016/j.ajogmf.2021.100440. Epub 2021 Jun 30. |
| 2764059 | Background | Jovanovic-Peterson L, Durak EP, Peterson CM. Randomized trial of diet versus diet plus cardiovascular conditioning on glucose levels in gestational diabetes. Am J Obstet Gynecol. 1989 Aug;161(2):415-9. doi: 10.1016/0002-9378(89)90534-6. |
| 11679479 | Background | Garcia-Patterson A, Martin E, Ubeda J, Maria MA, de Leiva A, Corcoy R. Evaluation of light exercise in the treatment of gestational diabetes. Diabetes Care. 2001 Nov;24(11):2006-7. doi: 10.2337/diacare.24.11.2006. No abstract available. |
| 35858653 | Background | Fishel Bartal M, Ashby Cornthwaite JA, Ghafir D, Ward C, Ortiz G, Louis A, Cornthwaite J, Chauhan SSP, Sibai BM. Time in Range and Pregnancy Outcomes in People with Diabetes Using Continuous Glucose Monitoring. Am J Perinatol. 2023 Apr;40(5):461-466. doi: 10.1055/a-1904-9279. Epub 2022 Jul 20. |
| 30461693 | Background | American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960. |
| 37256333 | Background | Gregory ECW, Ely DM. Trends and Characteristics in Prepregnancy Diabetes: United States, 2016-2021. Natl Vital Stat Rep. 2023 May;72(6):1-13. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |