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OpenTrials
Completed

NCT Number: NCT05608226

Impact of Health Lifestyle on Body Weight

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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Key information

Conditions

Body-Weight Trajectory Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiaoying Li

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Education Program

Behavioral

A remotely delivered structured lifestyle education program adapted from conventional lifestyle interventions

Primary outcomes

  1. Change in body weight

    Time frame: 6 months

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

Secondary outcomes

  1. Change in blood lipids

    Time frame: 6 months

    To examine the change in blood lipids from baseline to 6 months following lifestyle education.

  2. Change in glycemic control

    Time frame: 6 months

    To examine the change in glycemic control from baseline to 6 months following lifestyle education.

  3. Change in blood pressure

    Time frame: 6 months

    To examine the change in blood pressure from baseline to 6 months following lifestyle education

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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