Overweight or ObesityNCT07045272
Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients
A study testing Experimental in people with Overweight or Obesity, run by Anhui Medical University.
Trial summary
This study applied digital technology to a comprehensive lifestyle intervention strategy to design a digital behavioural intervention programme suitable for weight reduction in overweight obese infertile patients in China, and assessed its intervention effect through a randomised controlled trial.The main questions it… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfilling the World Health Organization diagnostic criteria for infertility, defined as failure to achieve or sustain a clinical pregnancy after ≥1 year of regular unprotected sexual intercourse among couples of reproductive age;
- patients aged 20-40 years seeking assisted reproductive technology (ART) treatment;
- Body mass index (BMI) >=24 kg/m²;
- Willingness to undergo randomization;
- Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies);
- Commitment to participate in and complete the intervention protocol.
Who cannot join
- History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder);
- Current or prior participation in other clinical trials within the past 3 months;
- Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias);
- Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.
About this study
Official title: Study on the Construction and Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients Prior to Assisted Reproductive Technology(ART)Treatment
This study applied digital technology to a comprehensive lifestyle intervention strategy to design a digital behavioural intervention programme suitable for weight reduction in overweight obese infertile patients in China, and assessed its intervention effect through a randomised controlled trial.The main questions it aims to answer are:
- Design and implement a digital behavioural weight loss intervention programme; 2) Evaluate the impact of digital behavioural interventions on weight loss outcomes and health outcomes.
Read more
Participants will be randomly assigned to a control group and an intervention group.
The control group will receive only routine health education and the intervention group will receive an 8-week digital behavioural intervention. At the end of the intervention, the follow-up period will be one year for reproductive outcomes.
- Conditions
- Overweight or Obesity
- Being tested
- Experimental
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
The intervention team provides lifestyle guidance to the subjects according to the behavioural intervention programme, and the subjects record information on diet, exercise and weight on the platform on a daily basis. Subjects are required to learn relevant health education knowledge on the platform by themselves, and they can also exchange experience in the group and receive motivational counselling from the instructors.
| Study group | Role | What they receive |
|---|---|---|
| digital behavioral intervention | Experimental | A comprehensive intervention program that combines digital technologies，Including interventions for diet, exercise, mood, sleep, etc. Receives: Behavioral: Experimental |
| Regular Education Group | No intervention | Physicians provided only their standard verbal counseling during clinic visits, without any additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: From enrollment to the end of treatment at 8 weeks
Number of oocytes retrieved
Measured: up to 16weeks
Number of embryos available for transfer
Measured: up to 17 weeks
Secondary outcomes (4)
Percentage of weight loss
Measured: From enrollment to the end of treatment at 8 weeks
Body fat content and distribution
using the InBody instrument, which relies on the principle of bioelectrical impedance analysis (BIA) to rapidly assess body composition without radiation exposure.
Measured: From enrollment to the end of treatment at 8 weeks
live birth rate
Measured: 2 years
Pregnancy rate
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Danni, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045272
- Sponsor's protocol ID
- WDanni
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Construction and Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients Prior to Assisted Reproductive Technology(ART)Treatment
- ClinicalTrials.gov ID
- NCT07045272
- Acronym / sponsor ID
- WDanni
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 1 Jul 2025 (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.
This study applied digital technology to a comprehensive lifestyle intervention strategy to design a digital behavioural intervention programme suitable for weight reduction in overweight obese infertile patients in China, and assessed its intervention effect through a randomised controlled trial.The main questions it aims to answer are:
- Design and implement a digital behavioural weight loss intervention programme; 2) Evaluate the impact of digital behavioural interventions on weight loss outcomes and health outcomes.
Participants will be randomly assigned to a control group and an intervention group.
The control group will receive only routine health education and the intervention group will receive an 8-week digital behavioural intervention. At the end of the intervention, the follow-up period will be one year for reproductive outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital behavioral intervention | Experimental | Behavioral: ExperimentalA comprehensive intervention program that combines digital technologies，Including interventions for diet, exercise, mood, sleep, etc. |
| Regular Education Group | No intervention | –Physicians provided only their standard verbal counseling during clinic visits, without any additional interventions. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Fulfilling the World Health Organization diagnostic criteria for infertility, defined as failure to achieve or sustain a clinical pregnancy after ≥1 year of regular unprotected sexual intercourse among couples of reproductive age;
- patients aged 20-40 years seeking assisted reproductive technology (ART) treatment;
- Body mass index (BMI) >=24 kg/m²;
- Willingness to undergo randomization;
- Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies);
Key exclusion criteria (4 listed)
- History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder);
- Current or prior participation in other clinical trials within the past 3 months;
- Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias);
- Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.
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 |
|---|---|---|
| ExperimentalThe intervention team provides lifestyle guidance to the subjects according to the behavioural intervention programme, and the subjects record information on diet, exercise and weight on the platform on a daily basis. Subjects are required to learn relevant health education knowledge on the platform by themselves, and they can also exchange experience in the group and receive motivational counselling from the instructors. | Behavioural | digital behavioral intervention |
Primary outcome
Weight change
Time frame: From enrollment to the end of treatment at 8 weeks
Number of oocytes retrieved
Time frame: up to 16weeks
Number of embryos available for transfer
Time frame: up to 17 weeks
4 secondary outcomes
Percentage of weight loss
Time frame: From enrollment to the end of treatment at 8 weeks
Body fat content and distribution
Time frame: From enrollment to the end of treatment at 8 weeks
live birth rate
Time frame: 2 years
Pregnancy rate
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Overweight or Obesity, run by Anhui Medical University.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Weight change (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 3 primary outcomes in all. 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 1 Jul 2025.