Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental.
- Who it may be relevant to
- Registry conditions: Overweight or Obesity. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral Experimental
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07045272 · WDanni