Trial · NCT00456521
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-primary: Body Weight- Mean Percent Change | Baseline, 56 weeks | |
| Primary | Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease | Baseline, 56 weeks | |
| Secondary | Body Weight- Proportion of Subjects With ≥10% Decrease | Baseline, 56 weeks | |
| Secondary | Change in Waist Circumference | Baseline, 56 weeks | |
| Secondary | Change in Fasting Triglycerides Levels, Using Log-transformed Data | Baseline, 56 weeks | |
| Secondary | Change in Fasting Insulin Levels, Using Log-transformed Data | Baseline, 56 weeks | |
| Secondary | Change in Fasting HDL Cholesterol Levels | Baseline, 56 weeks | |
| Secondary | Change in IWQOL-Lite Total Scores | Baseline, 56 weeks | IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment |
| Secondary | Change in HOMA-IR Levels, Using Log-transformed Data | Baseline, 56 weeks | HOMA-IR= Homeostasis Model Assessment-Insulin Resistance |
| Secondary | Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Baseline, 56 weeks | |
| Secondary | Change in Fasting Blood Glucose Levels | Baseline, 56 weeks | |
| Secondary | Change in Fasting LDL Cholesterol | Baseline, 56 weeks | |
| Secondary | Change in Systolic Blood Pressure | Baseline, 56 weeks | |
| Secondary | Change in Diastolic Blood Pressure | Baseline, 56 weeks | |
| Secondary | Change in IDS-SR Total Scores | Baseline, 56 weeks | IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression. |
| Secondary | Change in Food Craving Inventory Sweets Subscale Scores | Baseline, 56 weeks | The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). |
| Secondary | Change in Food Craving Inventory Carbohydrates Subscale Scores | Baseline, 56 weeks | The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). |
| Secondary | Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire | Baseline, 56 weeks | Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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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