Overweight or Obesity
Conditions
Brief 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.
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.
Sponsors
Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change | From enrollment to the end of treatment at 8 weeks |
| Number of oocytes retrieved | up to 16weeks |
| Number of embryos available for transfer | up to 17 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of weight loss | From enrollment to the end of treatment at 8 weeks | — |
| Pregnancy rate | up to 1 year | — |
| Body fat content and distribution | From enrollment to the end of treatment at 8 weeks | using the InBody instrument, which relies on the principle of bioelectrical impedance analysis (BIA) to rapidly assess body composition without radiation exposure. |
| live birth rate | 2 years | — |
Outcome results
None listed