protocolSection identificationModule nctId: NCT06292936, orgStudyIdInfo id: 30692, briefTitle: RemI for Post-Bariatric Surgery Weight Regain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Temple University, class: OTHER, collaborators name: Rush University, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).The main research aims are:1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior., conditionsModule conditions: Obesity, conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance-Based Behavioral Intervention, outcomesModule primaryOutcomes measure: Weight, secondaryOutcomes measure: Caloric Intake, secondaryOutcomes measure: Eating Behavior - Cognitive Constraint, secondaryOutcomes measure: Eating Behavior - Disinhibition, secondaryOutcomes measure: Eating Behavior - Hunger, secondaryOutcomes measure: Physical Activity, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with hypertension, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with diabetes, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia, secondaryOutcomes measure: Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia, otherOutcomes measure: Mechanisms of Action (Exploratory) - Acceptance of food-related internal experiences, otherOutcomes measure: Mechanisms of Action (Exploratory) - Mindfulness, otherOutcomes measure: Mechanisms of Action (Exploratory) - Defusion, otherOutcomes measure: Mechanisms of Action (Exploratory) - Values clarity, otherOutcomes measure: Mechanisms of Action (Exploratory) - Depressive symptoms, otherOutcomes measure: Mechanisms of Action (Exploratory) - Anxiety, otherOutcomes measure: Mechanisms of Action (Exploratory) - Internal states, otherOutcomes measure: Mechanisms of Action (Exploratory) - Maladaptive eating behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Lauren Bradley, PhD, role: CONTACT, phone: 312-942-2714, email: lauren_e_bradley@rush.edu, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Temple University, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: David B Sarwer, PhD, role: CONTACT, phone: 215-707-8632, email: dsarwer@temple.edu, contacts name: Sarah R Fischbach, MPH, role: CONTACT, phone: 215-707-8633, email: sarah.fischbach@temple.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False