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Impact of Health Lifestyle on Body Weight

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05608226
Collaborator
(none)
190
Enrollment
1
Location
12.5
Anticipated Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    190 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Health Lifestyle on Body Weight Post Cessation of Pharmacotherapy in Obese Subjects
    Actual Study Start Date :
    Sep 15, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Fluctuation in body weight [6 months]

      To examine the weight fluctuation by health lifestyle compliance from baseline

    Secondary Outcome Measures

    1. Change of blood lipids [6 months]

      To examine the change of blood lipids by health lifestyle compliance from baseline

    2. Change of blood glucose levels [6 months]

      To examine the change of blood glucose levels by health lifestyle compliance from baseline

    3. Change of blood pressure [6 months]

      To examine the change of blood pressure by health lifestyle compliance from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xiaoying Li Shanghai China

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05608226
    Other Study ID Numbers:
    • ZSE-2210
    First Posted:
    Nov 8, 2022
    Last Update Posted:
    Nov 28, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Body Weight
    Body-Weight Trajectory

    Study Results

    No Results Posted as of Nov 28, 2022