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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| digital behavioral intervention | Experimental | A 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Behavioral | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of weight loss | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| From enrollment to the end of treatment at 8 weeks |
| live birth rate | 2 years |
| Pregnancy rate | up to 1 year |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |