CClinicalTrials.gg
Not yet recruitingNCT07045272Updated Jul 1, 2025

Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients

An interventional study of Experimental in Overweight or Obesity, sponsored by Anhui Medical University. Not yet recruiting. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Anhui Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
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Study 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 aims to answer are:

1) 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.

02

Conditions studied

  • Overweight or Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's planned enrollment of 90 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Anhui Medical University is the lead sponsor of 102 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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;
  2. patients aged 20-40 years seeking assisted reproductive technology (ART) treatment;
  3. Body mass index (BMI) >=24 kg/m²;
  4. Willingness to undergo randomization;
  5. Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies);
  6. Commitment to participate in and complete the intervention protocol.

Exclusion criteria

Exclusion Criteria:

  1. History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder);
  2. Current or prior participation in other clinical trials within the past 3 months;
  3. Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias);
  4. Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    digital behavioral intervention

    A comprehensive intervention program that combines digital technologies,Including interventions for diet, exercise, mood, sleep, etc.

    Behavioral: Experimental

  • No intervention
    Regular Education Group

    Physicians provided only their standard verbal counseling during clinic visits, without any additional interventions.

Interventions

  • BehavioralExperimental

    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.

06

What researchers measure

Primary outcomes

  1. Weight change

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Number of oocytes retrieved

    Time frame: up to 16weeks

  3. Number of embryos available for transfer

    Time frame: up to 17 weeks

Secondary outcomes

  1. Percentage of weight loss

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. live birth rate

    Time frame: 2 years

  4. Pregnancy rate

    Time frame: up to 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07045272
Lead sponsor
Anhui Medical University
Responsible party
Wang Danni (Associate Professor, Anhui Medical University) — Principal investigator
First posted
Jul 1, 2025
Start date
Jul 10, 2025 (estimated)
Primary completion
Aug 20, 2026 (estimated)
Completion
Aug 20, 2027 (estimated)
Last update
Jul 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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