None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1 Adults aged 20 50 years. The age group was selected to exclude age-related degenerative cognitive changes. 2 Participants with obesity (the protocol appears to contain a typographical error stating BMI more than 25 kg per msq, given the study population and title, this should likely refer to obesity and may need verification from the investigators). 3. Minimum high school education and above. 4. Willing to provide informed consent and comply with regular follow-up. Exclusion Criteria 1. Pregnancy or lactation at the time of study, or planning pregnancy within the next year. 2. Acute infections and advanced end-organ damage. 3. Severe end-organ damage or chronic diseases such as renal failure, hepatic failure, or malignancy. 4. Any serious medical or psychiatric condition interfering with the intervention. 5. Smoking or recent smoking cessation that could affect weight gain. 6. Metabolic disorders or other health conditions affecting weight. 7. Use of weight-loss medications or enrollment in formal weight-loss programs. 8. Obese patients diagnosed with eating disorders. 9. History of head injury or seizures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Pregnancy or lactation at the time of study, or planning pregnancy within the next year. 2. Acute infections and advanced end-organ damage. 3. Severe end-organ damage or chronic diseases such as renal failure, hepatic failure, or malignancy. 4. Any serious medical or psychiatric condition interfering with the intervention. 5. Smoking or recent smoking cessation that could affect weight gain. 6. Metabolic disorders or other health conditions affecting weight. 7. Use of weight-loss medications or enrollment in formal weight-loss programs. 8. Obese patients diagnosed with eating disorders. 9. History of head injury or seizures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of clinically significant weight loss i.e. more than 5 percent reduction from baseline body weight at 6 months following interventionTimepoint: Achievement of clinically significant weight loss i.e. more than 5 percent reduction from baseline body weight at 6 months following intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Improvement in cognitive functioning as assessed by MMSE and NIMHANS Neuropsychological Battery scores (attention, memory, executive functions) at 6 months. (2)Improvement in eating behavior as assessed by the Three Factor Eating Questionnaire at 6 months. (3)Changes in anthropometric measures, body composition, and metabolic parameters at 6 months Timepoint: at 6 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences