Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT03086161
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2017-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mood and Excess Weight Gain in Adolescent Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079062', 'term': 'Interpersonal Psychotherapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Care providers delivering usual prenatal care are unaware of condition assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of recruitment', 'timeFrame': '5-year period', 'description': 'Rate of recruitment'}, {'measure': 'Acceptability', 'timeFrame': '6-9 months', 'description': 'Program session attendance measured as percentage of total sessions (6) attended'}, {'measure': 'Acceptability of program', 'timeFrame': '6-9 months', 'description': 'Program acceptability ratings'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': '12 months (9 months of pregnancy plus 3 months postpartum)', 'description': 'Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale'}, {'measure': 'Perceived stress', 'timeFrame': '12 months (9 months of pregnancy plus 3 months postpartum)', 'description': 'Perceived stress measured on the Perceived Stress Scale'}, {'measure': 'Excess gestational weight gain', 'timeFrame': '9 months', 'description': 'Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery'}, {'measure': 'Maternal postpartum insulin sensitivity', 'timeFrame': '12 months (9 months of pregnancy plus 3 months postpartum)', 'description': 'Maternal postpartum insulin sensitivity'}, {'measure': 'Maternal postpartum adiposity', 'timeFrame': '12 months (9 months of pregnancy plus 3 months postpartum)', 'description': 'Maternal postpartum body fat percentage'}, {'measure': 'Infant adiposity', 'timeFrame': 'Infants: 3 months', 'description': 'Infant body fat percentage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Adolescent Development', 'Pregnancy Related', 'Insulin Sensitivity', 'Interpersonal Relations', 'Stress']}, 'referencesModule': {'references': [{'pmid': '32206334', 'type': 'DERIVED', 'citation': 'Shomaker LB, Gulley LD, Clark ELM, Hilkin AM, Pivarunas B, Tanofsky-Kraff M, Nadeau KJ, Barbour LA, Scott SM, Sheeder JL. Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents. Pilot Feasibility Stud. 2020 Mar 20;6:39. doi: 10.1186/s40814-020-00578-1. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': "50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.", 'detailedDescription': "Obesity and its negative health consequences such as type 2 diabetes and heart disease are major public health concerns. Pregnancy is an ideal opportunity to intervene with young women both to reduce their own likelihood of long-term obesity and to potentially lessen their offspring's obesity risk. Interventions to reduce excessive weight gain during adolescent pregnancy may be particularly important. 50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. Depression and stress-which are common in adolescent pregnancy-also may play a role. Pregnant adolescent females, as well as non-pregnant females, who have more frequent feelings of depression or stress are more likely to gain weight too rapidly or to gain too much weight as they grow. In the current project, the investigators seek to develop a program to prevent excess weight gain that will be feasible to administer in the Colorado Adolescent Maternity Program (CAMP) at Children's Hospital Colorado, University of Colorado Denver, Anschutz Medical Campus, and, that will be acceptable to pregnant teens at-risk for gaining too much weight. After a screening assessment, adolescent females (13-19y) will be randomly assigned to participate in either a 6-session interpersonal psychotherapy (IPT) program + usual care or to CAMP usual care only. The IPT program will involve 6 1-hour meetings with a trained facilitator and focus on improving relationships, mood, stress, and eating in response to negative feelings. The investigators will assess participants midway through the program, immediately after the program, and again at a 3-month postpartum follow-up. The investigators will evaluate to what extent adolescent females attend the program, complete at-home practice assignments, and show changes in mood, stress, relationships, eating, and mindfulness before and after IPT participation compared to usual care only. The investigators also will estimate how program participation relates to weight gain during pregnancy and 3-month postpartum maternal weight retention, adiposity, and insulin sensitivity. The investigators also will study the adiposity of adolescents' 3-month-old infants."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 13-19 years of age and the 3-6 month old infants of these adolescent mothers\n* Female\n* Pregnant, 12-18 weeks gestation\n* Patient in the Colorado Adolescent Maternity Program (CAMP) clinic\n\nExclusion Criteria:\n\n* Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)\n* Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder\n* Medication affecting mood or body weight\n* Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)\n* Pre-pregnancy BMI \\<5th percentile for age and sex'}, 'identificationModule': {'nctId': 'NCT03086161', 'briefTitle': 'Mood and Excess Weight Gain in Adolescent Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Colorado State University'}, 'officialTitle': 'Mood and Excess Weight Gain in Adolescent Pregnancy', 'orgStudyIdInfo': {'id': '14-1505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-as-usual', 'description': 'Treatment-as-usual alone provided in the context of a multi-disciplinary teen pregnancy clinic providing wrap-around medical, nutrition, and social work care.', 'interventionNames': ['Behavioral: Treatment-as-usual']}, {'type': 'EXPERIMENTAL', 'label': 'Interpersonal Psychotherapy', 'description': 'Treatment-as-usual plus a six-session interpersonal psychotherapy program delivered as individual sessions by a trained facilitator every 2-3 weeks throughout pregnancy.', 'interventionNames': ['Behavioral: Interpersonal Psychotherapy', 'Behavioral: Treatment-as-usual']}], 'interventions': [{'name': 'Interpersonal Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Six individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy', 'armGroupLabels': ['Interpersonal Psychotherapy']}, {'name': 'Treatment-as-usual', 'type': 'BEHAVIORAL', 'description': 'Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work', 'armGroupLabels': ['Interpersonal Psychotherapy', 'Treatment-as-usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Lauren B Shomaker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': "Children's Hospital Colorado", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}