Impact of Health Lifestyle on Body Weight

Recruiting

• Conditions: Body-Weight Trajectory

• Registration Number: NCT05608226
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Pharmacotherapy becomes an important and effective approach to improve body weight. However, it still remains unclear how to manage potential fluctuation after its cessation. Lifestyle change is the foundation and included as a part of clinical routine in real-world, therefore, we plan to conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from treatment. In addition, body weight related results will be described.

Detailed Description

Novel pharmacotherapy is emerging, leading to substantial and sustained improvement in body weight compared with placebo in clinical trials. However, there is no evidence on management of body weight in real world setting after cessation of treatment. Body weight fluctuation is a pivotal difficulty for obese subjects who left off pharmacotherapy. It would be interesting to investigate the impact of real-world health lifestyle and its compliance in this clinical situation and probe into factors affecting compliance. Therefore, we will conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from pharmacotherapy cessation. In addition, body weight related results will be described.

Study Timeline

• Study Start: 2022-09-15
• Status Verified: 2022-11
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-28
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• All patients who completed a pharmacotherapy trial
• Those who consent to this FU study

Exclusion Criteria

• Those who do not consent to this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fluctuation in body weight	6 months	To examine the weight fluctuation by health lifestyle compliance from baseline

Secondary Outcome Measures

Name	Time	Method
Change of blood lipids	6 months	To examine the change of blood lipids by health lifestyle compliance from baseline
Change of blood glucose levels	6 months	To examine the change of blood glucose levels by health lifestyle compliance from baseline
Change of blood pressure	6 months	To examine the change of blood pressure by health lifestyle compliance from baseline

Trial Locations

Locations (1)

Xiaoying Li; 🇨🇳 Shanghai, China