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临床试验/NCT05608226
NCT05608226已完成不适用

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

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Change in body weight

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •Those who do not consent to this study

研究组 & 干预措施

Lifestyle Education Group

Participants chose to receive a structured remotely delivered lifestyle education program during the 26-week weight loss maintenance period.

干预措施: Lifestyle Education Program (Behavioral)

Non-Education Group

Participants chose not to receive the structured lifestyle education program during the 26-week weight loss maintenance period.

结局指标

主要结局

Change in body weight

时间窗: 6 months

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

次要结局

  • Change in blood lipids(6 months)
  • Change in glycemic control(6 months)
  • Change in blood pressure(6 months)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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