Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Understand the procedures and methods of the study, participate in the trial voluntarily, be able to cooperate with the trial, and sign the informed consent in writing; 2. Male, aged 20-40 years, with BMI between 28-35kg/m^2, and diagnosed as obesity by a specialist; no other weight loss treatment has been received in the last 2 months; 3. Screen positive for insomnia symptoms on the Sleep Status Index and meet DSM-5 criteria for insomnia disorders; 4. Self-reported sleep efficiency of less than 85% in the past month; 5. Ability to attend appointments and comply with study procedures during the trial period.
Exclusion criteria
Exclusion criteria: 1. A history of strenuous exercise, tobacco or caffeine use, a history of alcohol consumption [more than 15g of alcohol per day (equivalent to 350mL of beer, 150mL of wine, or 45mL of distilled spirits) more than twice per week], or a history of substance abuse; 2. A history of a medical condition that may interfere with the interpretation of the results that could lead to secondary obesity, such as cortisolism, hypothyroidism, hypothalamic or pituitary disorders, pancreatic related disorders such as pancreatic beta-cell tumors, and so on; 3. Diseases for which sleep restriction therapy may be contraindicated or render inappropriate or ineffective: additional diagnoses of sleep disorders (e.g.restless legs syndrome, obstructive sleep apnea, or episodic somnambulism) or dementia or mild cognitive impairment; epilepsy, schizophrenia, or bipolar disorder; 4. Current suicidal ideation or attempted suicide within the past 2 months; 5. Currently undergoing cancer treatment or planning to undergo major surgery during the treatment phase; 6. Working nights, evenings, early mornings or shifts; 7. Currently receiving psychotherapy for insomnia from a health professional or participating in an online insomnia treatment program; 8. Ineligible for enrollment due to the presence of a major medical condition: previous history of myocardial infarction, coronary heart disease, angina pectoris, heart failure (class II-IV), severe arrhythmia (e.g., atrial fibrillation, need for a pacemaker); 9. History of hepatitis B, hepatitis C, AIDS, syphilis and other infectious diseases; 10. Patients with moderate to severe anemia (hemoglobin less than 90g/L); 11. Those who have participated in blood donation or lost 400mL or more of blood within 3 months prior to the screening, or those who have received blood transfusion within 3 months prior to the screening; 12. Those who have had serious trauma or major surgery within 1 month prior to screening, or those who plan to undergo surgery during the trial; 13. Any condition that, in the opinion of the investigator, may cause the subject to be unable to complete the study or pose a significant risk to the subject, or any other factor that reduces the likelihood of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phsical Examination;Body Composition Analysis;Sleep Analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS scoring scale;Total energy intake per day; | — |
Countries
China
Contacts
The First People's Hospital of Xiangtan City