Weight Cycle Post Intervention

Withdrawn

• Conditions: Weight Gain

• Registration Number: NCT05556577
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The aim of this follow-up (FU) study is to examine trajectory of body weight impacted by self-reported diet patterns and physical activities in 6 months at 3 monthly intervals from treatment cessation among patients who completed a pharmacotherapy trial. In addition, patient self-reported diet patterns and physical activities at respective time points will be described.

Detailed Description

This is a real-world prospective observational study with primary data collection. All participants with a background be recommended to adopt lifestyle intervention as chronic weight management in China clinical practice. This FU study will enroll patients who completed SURMOUNT-CN trials, with planed study duration of 6 months. No investigational medicine is applied in this prospective follow-up study.

Patients are requested to report body weight, waist circumferences, blood pressure, diet, physical activities, and laboratory results if available, at 3 monthly intervals during the 6-month follow-up period. Patients are also asked if they receive any Anti-Obesity medication (AOM) or participate in any interventional clinical trials indicated for weight management during study period. Summary statistics will be respectively applied to examine changes from trial baseline (time at trial randomization, week 0) and study baseline (time at 52 weeks from trial randomization, week 52) to each scheduled follow-up (at week 65 and week 78) by study arms in SURMOUNT-CN trial.

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-28
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

Exclusion Criteria

• Those in the SURMOUNT-CN trial who denied to participant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change in body weight	at week 65 and week 78 from study baseline