Weight Cycle Post Intervention

Weight Gain Clinical Trial

Official title:

Weight Cycle Impacted by Health Lifestyle Post Pharmacotherapy Intervention

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05556577
• Other study ID #: 2020-084
• Status: Withdrawn
• Start date: September 15, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: November 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Weight Gain

Intervention

Drug:
• investigational medicine product (IMP)
Investigational medicine product (IMP) received at SURMOUNT-CN trial

Other:
• placebo
Placebo received at SURMOUNT-CN trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in body weight		at week 65 and week 78 from study baseline