Clinical Trial: Effect of Intensive Behavioral Intervention on Weight-Loss Maintenance After Discontinuation of Incretin-Based Anti-Obesity Therapy: A Multicenter Randomized Controlled Trial (Japan)

Tokyo, Aug. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062659) titled 'Effect of Intensive Behavioral Intervention on Weight-Loss Maintenance After Discontinuation of Incretin-Based Anti-Obesity Therapy: A Multicenter Randomized Controlled Trial' on Aug. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Shinkomonji Hospital

Condition: Condition - Obesity Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether intensive behavioral intervention, compared with standard lifestyle counseling, reduces weight regain and improves weight-loss maintenance after discontinuation of incretin-based anti-obesity therapy in patients with obesity. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intensive behavioral intervention group: Participants will receive outpatient follow-up and nutritional counseling every 4 weeks for 12 months after discontinuation of incretin-based anti-obesity therapy. In addition to standard nutritional and lifestyle counseling, the intensive behavioral intervention will include self-weighing, self-monitoring of dietary intake and physical activity, individualized goal setting, assessment and feedback on goal attainment, problem-solving support, and behavioral plan adjustment in response to weight regain. Interventions/Control_2 - Standard intervention group: Participants will receive outpatient follow-up every 4 weeks for 12 months after discontinuation of incretin-based anti-obesity therapy.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Men and women aged 20 to 75 years. 2. Patients with obesity who have received anti-obesity treatment with semaglutide or tirzepatide for at least 52 weeks. 3. Patients who have achieved a body weight reduction of >=5% from initiation to discontinuation of anti-obesity therapy. 4. Patients who are scheduled to discontinue semaglutide or tirzepatide upon completion of the planned treatment period. 5. Patients for whom body weight at initiation and discontinuation of anti-obesity therapy is available. 6. Patients who provide written informed consent to participate in the study. Key exclusion criteria - 1. Pregnant or breastfeeding women, or women planning pregnancy during the study period. 2. Patients who are scheduled to initiate or use medications expected to substantially affect body weight, including other anti-obesity medications, during the study period. 3. Patients planning bariatric surgery or other invasive weight-loss procedures during the study period. 4. Patients with severe cardiac, hepatic, renal, malignant, or other serious diseases that, in the investigator's judgment, would interfere with participation in the study or completion of the 12-month follow-up. 6. Patients with psychiatric disorders or cognitive impairment that may substantially interfere with adherence to or assessment of the study intervention. 7. Patients considered unsuitable for participation in the study by the investigator. Target Size - 300

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 27 Day Date of IRB - 2026 Year 08 Month 06 Day Anticipated trial start date - 2026 Year 08 Month 22 Day Last follow-up date - 2028 Year 02 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071727

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