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Development and Evaluation of a Cognitive Retraining Module for Weight Loss in Obesity: An Open-Label RCT Groups

Development and evaluation of comprehensive cognitive retraining module for patients with obesity to achieve clinically significant weight loss -An Open Label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112869
Enrollment
200
Registered
2026-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Intervention group: Comprehensive Cognitive Retraining Module: Comprehensive Cognitive Retraining Module will consist of six sessions of counseling, once in month with each session cons

Sponsors

Department Of Science and Technology
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Piyush Ranjan

All India Institute of Medical Sciences

drpiyushdost@gmail.com9268714198

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026