Trial · NCT06620562
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight loss | baseline to 24 months | % Excess weight loss |
| Primary | Percentage of participant with an Excess Weight Loss above 50% | Baseline to 24 months | |
| Secondary | Resolution of associated comorbidities | Baseline to 24 months | Type 2 diabetes, hypertension and dislipidemia |
| Secondary | Improvement of Eating behaviors (Food Craving State Questionnaire) | Baseline to 24 months | Evaluates severity of cravings using a validated questionnaire. Minimum : 15; Maximum : 75; Higher scores mean a worse outcome. |
| Secondary | Improvement of Eating behaviors (Food Craving Trait Questionnaire) | Baseline to 24 months | Evaluates severity of cravings using a validated questionnaire. Minimum : 39; Maximum : 234; Higher scores mean a worse outcome. |
| Secondary | Decrease in food explicit and implicit wanting and liking food reward. | Baseline to 24 month | Decrease in food explicit and implicit wanting and liking food reward assessed by Leeds Food Preference Questionnaire using a computerized behavioural task |
| Secondary | Improvement in well-being, mood and Quality of Life (SF-36) | Baseline to 24 months | 36-item short form survey evaluating quality of life on a scale from 0 to 100, higher scores indicate better quality of life |
| Secondary | Improvement in well-being, mood and Quality of Life (QLaval) | Baseline to 24 months | Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life |
| Secondary | Improvement in well-being, mood and Quality of Life (HAD questionnaire) | Baseline to 24 months | HAD questionnaire includes 14 rated items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), obtaining two scores (maximum score of each score = 21). Higher scores indicate a worse outcome |
| Secondary | Gastro-intestinal side-effects | Baseline to 24-month | Gastro-intestinal side-effects assessed by GIQLI questionnaire on a scale from 0 to 144. Higher scores indicate better quality of life |
| Secondary | Improvement of Eating behaviors (Binge Eating Scale) | Baseline to 24 months | To assess the presence of certain binge eating behaviors that may be indicative of an eating disorder. The higher the score, the more binge eating behaviors is observed. The minimum score is 0 while the maximum score is 46. The final result allows to say if the person has an absent (less than 17), moderate (between 18 and 26) or severe (more than 27) binging level. |
| Secondary | Improvement of Eating behaviors (YFAS 2.0) | Baseline to 24 months | The YFAS 2.0 was designed to assess food addiction. It assesses the symptoms of food addiction and the resulting distress and impaired functioning. The higher the level of symptoms, the more severe the food addiction. Impaired functioning and distress are scored from 0 to 2. Symptoms are scored from 0 to 11. If the functioning and distress score is 1 and above, the food addiction may be mild (2-3 symptoms), moderate (4-5 symptoms), or severe (6+ symptoms). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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