protocolSection identificationModule nctId: NCT06273163, orgStudyIdInfo id: STU-2023-1168, briefTitle: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: UT Southwestern Nutrition Obesity Research Center, descriptionModule briefSummary: Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (\~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized repeated measures between-subjects design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Complete masking is not feasible given the nature of the interventions - the program coordinator and participants will know if the participant receives home delivered medically tailored meals, a smart device application subscription, or usual care. The care provider will not be told the participants group assignment, but the participant may reveal it themselves in discussions with the provider., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Medically tailored meals, interventions name: Noom®, interventions name: Usual care, outcomesModule primaryOutcomes measure: Intervention Adherence, primaryOutcomes measure: Intervention Satisfaction, secondaryOutcomes measure: Percent weight loss maintained, secondaryOutcomes measure: Diet quality, otherOutcomes measure: Incremental cost effective ratio (ICER), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Southwestern Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Carolyn Haskins, MS, role: CONTACT, email: niche@utsouthwestern.edu, contacts name: Jessica ‪ Turcios, BS, role: CONTACT, email: niche@utsouthwestern.edu, contacts name: Kelseanna Hollis-Hansen, PhD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False