Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-01 @ 5:33 PM
Study NCT ID:
NCT03564392
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2018-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Bariatric Weight Regain Behavioral Intervention
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2018-04-26', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Loss of Control Eating Scale (LOCES)', 'timeFrame': '10 weeks', 'description': 'LOCES measures loss of control eating.'}, {'measure': 'Repetitive Eating Assessment-Questionnaire (Rep(eat))', 'timeFrame': '10 weeks', 'description': 'Rep(eat) measures grazing behaviors.'}, {'measure': 'Emotional Eating Scale (EES)', 'timeFrame': '10 weeks', 'description': 'EES will be used to measure emotional eating'}, {'measure': 'The Eating Inventory', 'timeFrame': '10 weeks', 'description': 'The Eating Inventory will be used to measure disinhibition.'}, {'measure': 'Paffenbarger Physical Activity Recall', 'timeFrame': '10 weeks', 'description': 'Paffenbarger will be used to measure physical activity engagement'}, {'measure': 'Philadelphia Mindfulness Scale (PHLMS)', 'timeFrame': '10 weeks', 'description': 'PHLMS will be used to measure mindfulness'}, {'measure': 'Drexel Defusion Scale (DDS)', 'timeFrame': '10 weeks', 'description': 'DDS will be used to measure delusion (a psychological construct of cognitive distancing)'}, {'measure': 'Food-Related Acceptance and Action Questionnaire (FAAQ)', 'timeFrame': '10 weeks', 'description': 'FAAQ will be used to measure food-related acceptance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "This project aims to evaluate a newly developed Internet-delivered (via e-learning modules) acceptance-based behavioral intervention (ABTi) for individuals who are experiencing weight regain after bariatric surgery. Specifically, the investigators aim to assess ABTi's efficacy on stopping and/or reversing weight by comparing it to a wait-list control (WLC) condition. The investigators also aim to evaluate its effect on targeted weight control behaviors and acceptance-based skills. Finally, the investigators will examine the relationship between weight outcomes and changes in process variables through exploratory analyses. Treatment outcomes (i.e., weight, maladaptive behaviors, physical activity, acceptance-based skills) will be measured at assessments pre-, mid-, and post-treatment, as well as at 3 months after treatment has ended.\n\nPrimary Aims.\n\n1. To test the hypothesis that participants randomly assigned to ABTi will display greater weight loss from pre- to post-treatment than those assigned to WLC.\n2. To test the hypothesis those receiving ABTi, compared to WLC, will display decreased maladaptive eating behaviors (i.e., loss of control episodes, grazing, emotional eating, disinhibition), increased physical activity, and greater improvements in acceptance-based skills (i.e., mindfulness, defusion, food-related acceptance).\n\nExploratory Aim.\n\n(1) To assess if changes in acceptance-based skills, maladaptive eating behaviors, and physical activity are associated with pre- to post-treatment weight outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has undergone any type of weight loss surgery at least 1.5 years ago\n* Demonstrate ≥ 10% weight regain of maximum weight loss or 5% of their minimum weight post-surgery, with weight regain lasting for at least 3 months prior to enrollment.\n* Ability to give consent and speak, write, and understand English.\n\nExclusion Criteria:\n\n* Currently enrolled in structured weight loss program\n* Currently pregnant/plan to become pregnant within 6 months of enrollment\n* Have a serious medical condition that has the potential of affecting weight or that would prevent engagement in dietary changes and/or an exercise regimen\n* Exhibit psychiatric symptoms that would interfere with the ability to benefit from the intervention, or report acute suicidality\n* Non-ambulatory (i.e., unable to walk at least one city block without a cane or walker at the time of screening\n* Use of medications known to affect body weight, such as chronic systemic steroids or psychiatric medications including lithium, tricyclic antidepressants, and antipsychotic agents'}, 'identificationModule': {'nctId': 'NCT03564392', 'briefTitle': 'Post-Bariatric Weight Regain Behavioral Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'The Investigation of a Remotely Delivered Behavioral Intervention for Postoperative Weight Regain', 'orgStudyIdInfo': {'id': '16062305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Ten weekly modules will be delivered through an e-learning platform (i.e., Coursesites). Each module includes a video presentation of material synchronized with a slideshow illustrating session material with interactive features, and directed assignments to be completed throughout the week. At the end of every two weeks, a brief (i.e., 20 min) telephone call with a member of the study team will be scheduled to discuss and clarify the content of the session, discuss how the participant utilized skills demonstrated in the session, problem-solve difficulties in utilizing the skills, and review homework. Participants will be required to weigh themselves weekly (data will be transferred wirelessly to the laboratory) and feedback regarding weight losses will be provided during the phone call. The interventionist will provide individualized feedback on food records via email.', 'interventionNames': ['Behavioral: Acceptance Based Behavioral Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control', 'description': 'The Wait-List Control (WLC) condition does not receive any intervention during the study period. They receive the intervention after completing the study.'}], 'interventions': [{'name': 'Acceptance Based Behavioral Intervention', 'type': 'BEHAVIORAL', 'description': "This intervention focuses on acceptance-based strategies with an emphasis on willingness to experience less pleasurable internal experiences (e.g., pleasure from eating calorically-dense foods) and aversive internal experiences (e.g., hunger, food cravings). Strategies to increase this willingness will be taught, including defusion (i.e., getting psychological distance from internal experiences to allow oneself to act independently of them). Mindful decision-making, as it relates to eating and exercise, will also be emphasized. Clarification and commitment to core values is another key component, as living life in accordance with one's values (e.g., health) makes willingness to make difficult choices worthwhile. Standard behavioral techniques for weight loss (i.e., self-monitoring, stimulus control, psychoeducation) will also be included.", 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lauren Bradley', 'investigatorAffiliation': 'Rush University Medical Center'}}}}