Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-04-24 @ 5:17 AM
Study NCT ID:
NCT02963428
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2016-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Teaching Appropriate Gestational Weight Gain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational weight gain, adjusting for time in the study', 'timeFrame': 'at delivery'}], 'secondaryOutcomes': [{'measure': 'Patient knowledge and expectations factors', 'timeFrame': 'Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum', 'description': 'Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors.'}, {'measure': 'Attitude on pregnancy weight gain', 'timeFrame': 'Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum', 'description': 'Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain.'}, {'measure': 'Self-efficacy of healthy eating', 'timeFrame': 'Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum', 'description': 'Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating.'}, {'measure': 'Eating, sleeping and physical activity behavior', 'timeFrame': 'Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum', 'description': 'Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors.'}, {'measure': 'Patient-experience and involvement in care', 'timeFrame': 'Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum', 'description': 'Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care.'}, {'measure': 'Delivery of large for gestational age infants', 'timeFrame': 'At Delivery', 'description': 'This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data.'}, {'measure': 'Diagnosis of gestational diabetes mellitus', 'timeFrame': 'Baseline through 4-12 Weeks Postpartum', 'description': 'This measure will be obtained using EHR data and analyzed utilizing clinic data points.'}, {'measure': 'Neonatal intensive care unit (NICU) admissions', 'timeFrame': 'At Delivery'}, {'measure': 'Cost of Treatment', 'timeFrame': 'Baseline through 4-12 Weeks Postpartum', 'description': 'Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost.'}, {'measure': 'Mode of delivery', 'timeFrame': 'At Delivery', 'description': 'Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest.'}, {'measure': 'Rate of gestational weight gain', 'timeFrame': 'Baseline through 4-12 weeks postpartum'}, {'measure': 'Perceived stress measured via Perceived Stress Scale', 'timeFrame': 'Baseline through 4-12 weeks postpartum', 'description': 'Perceived Stress will be measured using the Perceived Stress Scale by Cohen et. al.'}, {'measure': 'Psychological factors measured via Pregnancy Weight Gain Attitude Scale', 'timeFrame': 'Baseline through 4-12 Weeks postpartum', 'description': 'Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.', 'detailedDescription': 'The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.\n\nThe primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)\n* Less than 16 weeks gestation\n* Gestational weight gain (GWG) less than \\< 11 pounds from their pre-pregnancy weight to time of potential study enrollment\n* Singleton gestation\n* Access to a phone\n\nExclusion Criteria:\n\n* BMI less than 30 kg/m2\n* Gestational age greater than or equal to 16 weeks\n* Active diagnosis of cancer on their electronic health record problem list\n* Acquired immunodeficiency syndrome (AIDS)\n* Palliative medicine patients\n* Multiple gestations\n* GWG in excess of 11 pounds prior to study enrollment\n* Patients with Non-Geisinger prenatal care providers\n* Vegan diet\n* Malabsorptive conditions\n* Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization\n* Non-English Speaking'}, 'identificationModule': {'nctId': 'NCT02963428', 'acronym': 'TAGG', 'briefTitle': 'Teaching Appropriate Gestational Weight Gain', 'organization': {'class': 'OTHER', 'fullName': 'Geisinger Clinic'}, 'officialTitle': 'Teaching Appropriate Gestational Weight Gain', 'orgStudyIdInfo': {'id': '2016-0205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SOC)', 'description': 'Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.'}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Care (EC)', 'description': 'In addition to standard of care, the study participants will also receive:\n\ni. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.', 'interventionNames': ['Behavioral: Enhanced Care']}], 'interventions': [{'name': 'Enhanced Care', 'type': 'BEHAVIORAL', 'otherNames': ['EC'], 'description': 'In addition to standard of care, the study participants will also receive:\n\ni. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.', 'armGroupLabels': ['Enhanced Care (EC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health System', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}], 'overallOfficials': [{'name': 'Awathif D Mackeen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Geisinger Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geisinger Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}