Impact of Health Lifestyle on Body Weight

NCT05608226 — Completed, 128 participants, Shanghai Zhongshan Hospital

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Impact of Health Lifestyle on Body Weight Post Cessation of Pharmacotherapy in Obese Subjects

Registry	NCT05608226
Status	Completed
Study type	Observational
Enrollment	128 (Actual)
Sponsor	Shanghai Zhongshan Hospital (Other)
Conditions	Body-Weight Trajectory
Interventions	Lifestyle Education Program (Behavioral)
Dates	start 2022-09-15, primary completion 2023-07-07, completion 2023-07-07, first posted 2022-11-08, last updated 2026-07-10
Locations	1 site in China

-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 study to assess the impact of health lifestyle education and related lifestyle adherence 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 lifestyle education and related lifestyle adherence on body weight related parameters in 6 months from treatment. In addition, body weight related results will be described.

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+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 lifestyle education and related lifestyle adherence in this clinical situation and explore factors associated with weight loss maintenance. Therefore, we will conduct a prospective study to assess the impact of lifestyle education and related lifestyle adherence 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 lifestyle education and related lifestyle adherence on body weight related parameters in 6 months from pharmacotherapy cessation. In addition, body weight related results will be described.

+Arms and interventions

Arm	Type	Interventions	Description
Lifestyle Education Group		Behavioral: Lifestyle Education Program	Participants chose to receive a structured remotely delivered lifestyle education program during the 26-week weight loss maintenance period.
Non-Education Group			Participants chose not to receive the structured lifestyle education program during the 26-week weight loss maintenance period.

Lifestyle Education Program (Behavioral): A remotely delivered structured lifestyle education program adapted from conventional lifestyle interventions

+Outcome measures

Primary outcomes

Change in body weight [6 months]: To examine the change in body weight from baseline to 6 months following lifestyle education.

Secondary outcomes

Change in blood lipids [6 months]: To examine the change in blood lipids from baseline to 6 months following lifestyle education.
Change in glycemic control [6 months]: To examine the change in glycemic control from baseline to 6 months following lifestyle education.
Change in blood pressure [6 months]: To examine the change in blood pressure from baseline to 6 months following lifestyle education

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* All patients who completed a pharmacotherapy trial with clinically meaningful weight loss (≥5%)
* Those who consent to this study

Exclusion Criteria:

* Those who do not consent to this study

+Locations (1)

Facility	City	Country	Status
Xiaoying Li	Shanghai	China