NCT05608226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

November 2, 2022

Last Update Submit

November 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fluctuation in body weight

    To examine the weight fluctuation by health lifestyle compliance from baseline

    6 months

Secondary Outcomes (3)

  • Change of blood lipids

    6 months

  • Change of blood glucose levels

    6 months

  • Change of blood pressure

    6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who completed a pharmacotherapy trial will be recruited and who consent to this follow-up study.

You may qualify if:

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

You may not qualify if:

  • Those who do not consent to this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaoying Li

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Body-Weight Trajectory

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

September 15, 2022

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations