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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
Last Updated

July 10, 2026

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

November 2, 2022

Last Update Submit

July 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

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

    6 months

Secondary Outcomes (3)

  • Change in blood lipids

    6 months

  • Change in glycemic control

    6 months

  • Change in blood pressure

    6 months

Study Arms (2)

Lifestyle Education Group

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

Behavioral: Lifestyle Education Program

Non-Education Group

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

Interventions

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

Lifestyle Education Group

Eligibility Criteria

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

Subjects who completed a pharmacotherapy trial with clinically meaningful weight loss (≥5%) and consented to this study.

You may qualify if:

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

Location

MeSH Terms

Conditions

Body-Weight Trajectory

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

July 7, 2023

Study Completion

July 7, 2023

Last Updated

July 10, 2026

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations