Body-Weight TrajectoryNCT05608226
Impact of Health Lifestyle on Body Weight
An observational study of Body-Weight Trajectory, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body-Weight Trajectory
- What is being tested?
- Lifestyle Education Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 7 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who completed a pharmacotherapy trial with clinically meaningful weight loss (≥5%) and consented to this study.
Who may be able to join
- All patients who completed a pharmacotherapy trial with clinically meaningful weight loss (≥5%)
- Those who consent to this study
Who cannot join
- Those who do not consent to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Health Lifestyle on Body Weight Post Cessation of Pharmacotherapy in Obese Subjects
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.
Read the 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 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.
- Conditions
- Body-Weight Trajectory
- Being tested
- Lifestyle Education Program
- Medical subject headings
- Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Education ProgramBehavioural
A remotely delivered structured lifestyle education program adapted from conventional lifestyle interventions
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Education Group | Participants chose to receive a structured remotely delivered lifestyle education program during the 26-week weight loss maintenance period. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
To examine the change in body weight from baseline to 6 months following lifestyle education.
Measured: 6 months
Secondary outcomes (3)
Change in blood lipids
To examine the change in blood lipids from baseline to 6 months following lifestyle education.
Measured: 6 months
Change in glycemic control
To examine the change in glycemic control from baseline to 6 months following lifestyle education.
Measured: 6 months
Change in blood pressure
To examine the change in blood pressure from baseline to 6 months following lifestyle education
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Sep 2022
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body-Weight TrajectoryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608226
- Sponsor's protocol ID
- ZSE-2210
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Lifestyle on Body Weight Post Cessation of Pharmacotherapy in Obese Subjects
- ClinicalTrials.gov ID
- NCT05608226
- Acronym / sponsor ID
- ZSE-2210
- Conditions
- Body-Weight Trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Education Group | – | Behavioral: Lifestyle Education ProgramParticipants chose to receive a structured remotely delivered lifestyle education program during the 26-week weight loss maintenance period. |
| Non-Education Group | – | –Participants chose not to receive the structured lifestyle education program during the 26-week weight loss maintenance period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who completed a pharmacotherapy trial with clinically meaningful weight loss (≥5%) and consented to this study.
Key inclusion criteria (2 listed)
- All patients who completed a pharmacotherapy trial with clinically meaningful weight loss (≥5%)
- Those who consent to this study
Key exclusion criteria (1 listed)
- Those who do not consent to this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Education ProgramA remotely delivered structured lifestyle education program adapted from conventional lifestyle interventions | Behavioural | Lifestyle Education Group |
Primary outcome
Change in body weight
Time frame: 6 months
To examine the change in body weight from baseline to 6 months following lifestyle education.
3 secondary outcomes
Change in blood lipids
Time frame: 6 months
Change in glycemic control
Time frame: 6 months
Change in blood pressure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body-Weight Trajectory, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.