Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
Study NCT ID:
NCT06129461
Status:
UNKNOWN
Last Update Posted:
2023-11-13
First Post:
2023-11-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000078064', 'term': 'Gestational Weight Gain'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D002032', 'term': 'Bulimia'}], 'ancestors': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006963', 'term': 'Hyperphagia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-11-04', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prenatal Eating Behaviors Screening Tool', 'timeFrame': 'From study entry in 2nd trimester of pregnancy through delivery', 'description': 'Eating disorder symptoms, including frequency of binge and loss-of-control eating'}, {'measure': 'Gestational weight gain', 'timeFrame': 'From study entry in 2nd trimester of pregnancy through delivery', 'description': 'Deviations from recommended gestational weight gain trajectories (in U.S. lbs)'}, {'measure': 'Food Craving Questionnaire - Trait - Reduced', 'timeFrame': 'From study entry in 2nd trimester of pregnancy through delivery', 'description': 'Frequency and intensity of food craving experiences'}], 'secondaryOutcomes': [{'measure': 'Food Craving Acceptance and Action Questionnaire', 'timeFrame': 'Assessed at baseline and 1-month post-intervention', 'description': 'Acceptance of and willingness to experience food cravings'}, {'measure': 'Obsessive Compulsive Eating Scale', 'timeFrame': 'Assessed at baseline and 1-month post-intervention', 'description': 'Intrusive thoughts and urges related to a craved target'}, {'measure': 'White Bear Suppression Inventory', 'timeFrame': 'Assessed at baseline and 1-month post-intervention', 'description': 'Thought suppression'}, {'measure': 'Detail and Flexibility Questionnaire', 'timeFrame': 'Assessed at baseline and 1-month post-intervention', 'description': 'Cognitive flexibility'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gestational weight gain', 'loss of control eating', 'binge eating', 'food craving', 'mobile health intervention', 'single session intervention', 'Acceptance and Commitment Therapy'], 'conditions': ['Pregnancy Weight Gain', 'Eating Disorders', 'Perinatal Problems', 'Binge Eating', 'Craving']}, 'referencesModule': {'references': [{'pmid': '40148844', 'type': 'DERIVED', 'citation': 'Costello K, Timko CA, Anderson D, Hormes JM. Validation of the intolerance of uncertainty scale-12 in a sample of pregnant people. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):363. doi: 10.1186/s12884-025-07434-1.'}, {'pmid': '38537903', 'type': 'DERIVED', 'citation': 'Hormes JM, Timko CA. A clinical trial protocol of a single-session self-guided acceptance-based online intervention targeting food cravings as predictors of disordered eating in pregnant people. Contemp Clin Trials. 2024 May;140:107515. doi: 10.1016/j.cct.2024.107515. Epub 2024 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater risk of deviation from recommended gestational weight gain trajectories, especially in those engaged in binge and loss of control eating. This study will explore the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings as powerful and modifiable predictors of binge and LOC eating in pregnancy.', 'detailedDescription': 'Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to a range of adverse health outcomes in pregnancy, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater rates of deviation from recommended weight gain trajectories, especially in those engaged in binge and loss of control eating. Food cravings are powerful triggers of binge and loss of control eating in non-pregnant populations with preliminary evidence linking cravings to disordered eating behaviors and greater weight gain in pregnancy as well. This study builds on preliminary evidence to suggest that acceptance-based approaches are effective in reducing the adverse impacts of cravings on behavior by exploring the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants as predictors of maladaptive eating behaviors and deviations from recommended gestational weight gain trajectories.\n\nThe efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants will be examined in a randomized controlled trial. Pregnant individuals in the second trimester (n = 130) who endorse current cravings will be randomly assigned to the intervention or an untreated control group. The intervention group will participate in a single-session, self-guided online workshop imparting skills grounded in Acceptance and Commitment Therapy, including acceptance, defusion, and present-moment awareness. Both groups will complete comprehensive assessments at baseline, one-month follow-up, and at full-term. The results of this initial efficacy trial will inform the integration of acceptance-based self-guided health coaching targeting food cravings into routine prenatal care to prevent adverse outcomes associated with disordered eating behaviors in pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and older\n* Current residence in the United States\n* Fluency in English\n* Currently pregnant in the second trimester\n* Experience of any food cravings\n\nExclusion Criteria:\n\n* None beyond not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06129461', 'briefTitle': 'A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University at Albany'}, 'officialTitle': 'A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People', 'orgStudyIdInfo': {'id': '23E225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'The intervention group will participate in a single-session, self-guided online intervention imparting skills grounded in Acceptance and Commitment Therapy. The one-hour workshop guides participants through evidence-based exercises, brief video clips, and reflection activities designed to clarify values and teach skills to foster acceptance, defusion, and present-moment awareness.', 'interventionNames': ['Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control group will not receive any intervention; they will complete assessments on the same schedule as the intervention group (baseline, 1 month, at full term)'}], 'interventions': [{'name': 'Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention will learn acceptance-based strategies for reducing the adverse impact of food cravings on eating behaviors. Unlike control-based strategies, acceptance-based strategies do not attempt to change the content or frequency of thoughts; rather, they foster willingness to acknowledge and experience uncontrollable thoughts, urges, and emotions as what they are - nothing more, nothing less. Acceptance-based approaches have demonstrated efficacy in reducing the adverse impact of food cravings on eating behaviors in non-pregnant samples.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julia M. Hormes, Ph.D.', 'role': 'CONTACT', 'email': 'jhormes@albany.edu', 'phone': '518-442-4911'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Deidentified and aggregate data may be made available to other researchers upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Albany', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Julia Hormes', 'investigatorAffiliation': 'University at Albany'}}}}