Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT03551535
Status:
WITHDRAWN
Last Update Posted:
2020-09-18
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitored Home Exercise in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study IRB approval expired', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence rate', 'timeFrame': '20 weeks', 'description': 'Total number of performed exercise sessions divided by prescribed exercise sessions (3 per week at minimum)'}], 'secondaryOutcomes': [{'measure': 'Gestational Diabetes', 'timeFrame': '20 weeks', 'description': 'Development of Gestational diabetes as determined by routine 1 hour and then subsequent 3 hour glucose testing results'}, {'measure': 'Maternal Weight Gain', 'timeFrame': '20 weeks', 'description': 'measured in kilograms'}, {'measure': 'Gestational age at delivery', 'timeFrame': 'One year', 'description': "Infant's gestational age at delivery"}, {'measure': 'Rate of Cesarean delivery', 'timeFrame': 'One year', 'description': 'measured as the number of cesarean deliveries per total number of deliveries'}, {'measure': 'Infant weight', 'timeFrame': 'One year', 'description': 'Infant weight in grams measured post delivery'}, {'measure': 'Neonatal Apgar scores', 'timeFrame': '1, 5, and 10 minutes of neonatal life', 'description': 'An assessment of neonatal wellbeing measured at 1, 5, and 10 minutes post-delivery, and is measured on a scale of 0-9, with 9 being the highest, and 0 being the lowest.'}, {'measure': 'Neonatal Intensive Care Unit (NICU) Admission Rate', 'timeFrame': 'One year', 'description': 'Rate of admission of infants post-delivery to the NICU'}, {'measure': 'Neonatal hypoglycemia rates', 'timeFrame': 'One year', 'description': 'Number of infants with hypoglycemia divided by the total number of delivered infants'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearable technology', 'Pregnancy', 'Exercise', 'Mobile Health'], 'conditions': ['Exercise', 'Mobile Health', 'Pregnancy', 'Gestational Diabetes']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'National Center for Chronic Disease Prevention and Health Promotion. National Diabetes Statistics Report, 2017.'}, {'pmid': '16672855', 'type': 'BACKGROUND', 'citation': 'Impact of physical activity during pregnancy and postpartum on chronic disease risk. Med Sci Sports Exerc. 2006 May;38(5):989-1006. doi: 10.1249/01.mss.0000218147.51025.8a.'}, {'pmid': '18845974', 'type': 'BACKGROUND', 'citation': 'Borodulin KM, Evenson KR, Wen F, Herring AH, Benson AM. Physical activity patterns during pregnancy. Med Sci Sports Exerc. 2008 Nov;40(11):1901-8. doi: 10.1249/MSS.0b013e31817f1957.'}, {'pmid': '21694556', 'type': 'BACKGROUND', 'citation': 'Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization. Global recommendations on physical activity for health. WHO (2010). Available at: http://www.who.int/dietphysicalactivity/publications/9789241599979/en. (Accessed: 23rd March 2018)'}, {'pmid': '15165657', 'type': 'BACKGROUND', 'citation': 'Oguma Y, Shinoda-Tagawa T. Physical activity decreases cardiovascular disease risk in women: review and meta-analysis. Am J Prev Med. 2004 Jun;26(5):407-18. doi: 10.1016/j.amepre.2004.02.007.'}, {'pmid': '26595585', 'type': 'BACKGROUND', 'citation': 'ACOG Committee Opinion No. 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstet Gynecol. 2015 Dec;126(6):e135-e142. doi: 10.1097/AOG.0000000000001214.'}, {'pmid': '15033644', 'type': 'BACKGROUND', 'citation': 'Dempsey JC, Sorensen TK, Williams MA, Lee IM, Miller RS, Dashow EE, Luthy DA. Prospective study of gestational diabetes mellitus risk in relation to maternal recreational physical activity before and during pregnancy. Am J Epidemiol. 2004 Apr 1;159(7):663-70. doi: 10.1093/aje/kwh091.'}, {'pmid': '28161306', 'type': 'BACKGROUND', 'citation': 'Wang C, Wei Y, Zhang X, Zhang Y, Xu Q, Sun Y, Su S, Zhang L, Liu C, Feng Y, Shou C, Guelfi KJ, Newnham JP, Yang H. A randomized clinical trial of exercise during pregnancy to prevent gestational diabetes mellitus and improve pregnancy outcome in overweight and obese pregnant women. Am J Obstet Gynecol. 2017 Apr;216(4):340-351. doi: 10.1016/j.ajog.2017.01.037. Epub 2017 Feb 1.'}, {'pmid': '27417680', 'type': 'BACKGROUND', 'citation': 'Song C, Li J, Leng J, Ma RC, Yang X. Lifestyle intervention can reduce the risk of gestational diabetes: a meta-analysis of randomized controlled trials. Obes Rev. 2016 Oct;17(10):960-9. doi: 10.1111/obr.12442. Epub 2016 Jul 15.'}, {'pmid': '19683692', 'type': 'BACKGROUND', 'citation': 'Phelan S. Pregnancy: a "teachable moment" for weight control and obesity prevention. Am J Obstet Gynecol. 2010 Feb;202(2):135.e1-8. doi: 10.1016/j.ajog.2009.06.008. Epub 2009 Aug 15.'}, {'pmid': '15535815', 'type': 'BACKGROUND', 'citation': 'Evenson KR, Savitz DA, Huston SL. Leisure-time physical activity among pregnant women in the US. Paediatr Perinat Epidemiol. 2004 Nov;18(6):400-7. doi: 10.1111/j.1365-3016.2004.00595.x.'}, {'pmid': '21420359', 'type': 'BACKGROUND', 'citation': 'Gaston A, Cramp A. Exercise during pregnancy: a review of patterns and determinants. J Sci Med Sport. 2011 Jul;14(4):299-305. doi: 10.1016/j.jsams.2011.02.006. Epub 2011 Mar 21.'}, {'pmid': '12962263', 'type': 'BACKGROUND', 'citation': 'Ning Y, Williams MA, Dempsey JC, Sorensen TK, Frederick IO, Luthy DA. Correlates of recreational physical activity in early pregnancy. J Matern Fetal Neonatal Med. 2003 Jun;13(6):385-93. doi: 10.1080/jmf.13.6.385.393.'}, {'pmid': '16445309', 'type': 'BACKGROUND', 'citation': "Poudevigne MS, O'Connor PJ. A review of physical activity patterns in pregnant women and their relationship to psychological health. Sports Med. 2006;36(1):19-38. doi: 10.2165/00007256-200636010-00003."}, {'pmid': '22616913', 'type': 'BACKGROUND', 'citation': 'Oostdam N, van Poppel MN, Wouters MG, Eekhoff EM, Bekedam DJ, Kuchenbecker WK, Quartero HW, Heres MH, van Mechelen W. No effect of the FitFor2 exercise programme on blood glucose, insulin sensitivity, and birthweight in pregnant women who were overweight and at risk for gestational diabetes: results of a randomised controlled trial. BJOG. 2012 Aug;119(9):1098-107. doi: 10.1111/j.1471-0528.2012.03366.x. Epub 2012 May 23.'}, {'pmid': '23763541', 'type': 'BACKGROUND', 'citation': "Olander EK, Atkinson L. Obese women's reasons for not attending a weight management service during pregnancy. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1227-30. doi: 10.1111/aogs.12195. Epub 2013 Jul 5."}, {'pmid': '23263891', 'type': 'BACKGROUND', 'citation': "Sui Z, Turnbull DA, Dodd JM. Overweight and obese women's perceptions about making healthy change during pregnancy: a mixed method study. Matern Child Health J. 2013 Dec;17(10):1879-87. doi: 10.1007/s10995-012-1211-8."}, {'pmid': '28544551', 'type': 'BACKGROUND', 'citation': 'Lau Y, Klainin-Yobas P, Htun TP, Wong SN, Tan KL, Ho-Lim ST, Chi C, Tsai C, Ong KW, Shorey S, Tam WSW. Electronic-based lifestyle interventions in overweight or obese perinatal women: a systematic review and meta-analysis. Obes Rev. 2017 Sep;18(9):1071-1087. doi: 10.1111/obr.12557. Epub 2017 May 22.'}]}, 'descriptionModule': {'briefSummary': 'The Study Investigators intend to study the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.', 'detailedDescription': "The obesity epidemic has affected the reproductive age population with a resultant increase in Gestational Diabetes Mellitus (GDM). Two to 10% of pregnant women are now diagnosed with gestational diabetes, imposing significant increased risk of maternal and fetal/neonatal morbidity and mortality.\n\nDiabetes and obesity can both be combated by participating in daily physical activity, and has been shown to be beneficial for women of all ages, including women that are pregnant. The health benefits of exercise in pregnancy have been extensively studied, demonstrating improved pregnancy outcomes \\[both maternal (decreased gestational weight gain, decreased rates of cesarean section, and reduced rates of pregnancy induced complications such as hypertension and pre-eclampsia) and neonatal (reduction in proportion of large for gestational age infants)\\] with no evidence of harm when not contraindicated. Research should now focus on determining the most feasible, constructive, and efficient methods to improve fitness in pregnant women.\n\nPregnancy provides an ideal opportunity to focus on physical health and fitness; however, physical activity recommendations are rarely met and physical activity consistently decreases in pregnancy. With the development of mobile, technology-based interventions, at-home fitness regimens are now more accessible, thus reducing logistical constraints and burdens posed by traditional physical activity interventions. Moreover, the sustainability of at-home fitness regimens may be more successful long-term/post-intervention due to ease of engagement and more personalized motivational tools. Finally, wearable technology provides real-time feedback of progress and compliance to the intervention team, allowing improved monitoring of goals and compliance. In this way, contemporaneous, mobile health technology can maximize patient care by providing a novel, efficient, low burden, and scalable method to pursue pregnancy fitness, the economic implications of which could be significant.\n\nThe objective of this study is to determine the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.\n\nThere will be two arms of the study: an intervention group that will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription, and a comparison group who will receive standard obstetric care, which will include counseling about diet and exercise utilizing American Congress of Obstetricians and Gynecologists (ACOG) guidelines and literature, as well as a FitBit heart rate + activity monitor to track activity levels via step count. The project team will not interact with the comparison group regarding the patient's activity levels during the study duration.\n\nA sample size of 25 women for each arm of the study (50 women total) will be recruited. Basic demographic data will be obtained for all enrolled subjects, including age, parity, pre-pregnancy BMI, family history of diabetes, history of GDM (and number of previously affected pregnancies), preterm birth history, and baseline activity level (type of job, exercise, hours of standing). All participants will be asked to fill out a physical activity in pregnancy readiness survey as well as a baseline, previously validated international physical activity questionnaire, which will be utilized for comparison to activity level data collected during the study period. All enrolled patients will receive a FitBit heart rate + activity monitor, which will provide overall activity data in the form of steps per day through the duration of the trial. Those randomized to the intervention group will also utilize the FitBit during exercise sessions to provide data on duration, heart rate, and intensity, all of which will confirm that exercise is being accomplished as prescribed. This immediate exercise compliance feedback will enable automated motivational factors to engage the patient and optimize their continued exercise participation. Data regarding mode of delivery as well as infant details will be collected by chart review by the research team. Long term follow up may be obtained via email surveys, thus patient emails will be obtained at the time of enrollment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant female participants only', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or greater\n* Singleton gestation\n* History of gestational diabetes\n* OR\n* BMI ≥30\n* OR\n* Significant family history of diabetes (two or more first degree relatives with DM)\n\nExclusion Criteria:\n\n* Non-English or non-Spanish speaking patients\n* Women unwilling to provide consent\n* Patients with current diagnosis of diabetes\n* Multiple gestation\n* Medical or pregnancy complications and/or comorbidities that preclude exercise in pregnancy\n* Unwillingness to commit to the prescribed exercise program'}, 'identificationModule': {'nctId': 'NCT03551535', 'briefTitle': 'Monitored Home Exercise in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Randomized Controlled Trial of the Feasibility and Adherence of a Prescribed, Monitored Home Exercise Program in High Risk Pregnant Women', 'orgStudyIdInfo': {'id': 'IRB00173362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity Intervention', 'description': 'Patients will be allocated to a physical activity intervention to be performed 3-5 days per week', 'interventionNames': ['Behavioral: Monitored, At-Home Exercise Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will receive standard counseling regarding activity recommendations in pregnancy'}], 'interventions': [{'name': 'Monitored, At-Home Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Patients will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription', 'armGroupLabels': ['Physical Activity Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jeanne Sheffield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}