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Trial · NCT02527200

Registered outcomes106

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 16 WeeksWeek 0, Week 16
Change in BMI SDS from baseline to week 16 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
PrimaryChange in Body Mass Index (BMI) Standard Deviation Score (SDS) From Baseline to 52 WeeksWeek 0, Week 52
Change in BMI SDS from baseline to week 52 is presented. BMI SDS also called Z-scores, was calculated using the following formula: Z=\[(y / M)\^L - 1\] / S\*L; where L, M and S are median (M), Box-cox power (L) and variation coefficient (S) of children/adolescents', y= individual BMI. BMI provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. Possible values range from -3 to +3, a negative score being beneficial.
SecondaryPercentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 16At week 16
Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 16.
SecondaryPercentage of Participants Achieving ≥ 5% Reduction in Baseline BMI at Week 52At week 52
Percentage of participants achieving more than or equal to (≥) 5% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 5% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 5% reduction in their baseline (week 0) BMI at week 52.
SecondaryPercentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 16At week 16
Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 16 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 16 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 16.
SecondaryPercentage of Participants Achieving ≥ 10% Reduction in Baseline BMI at Week 52At week 52
Percentage of participants achieving more than or equal to (≥) 10% reduction in their baseline (week 0) BMI at week 52 is presented. In below table, 'Yes' infers percentage of participants who achieved ≥ 10% reduction in their baseline (week 0) BMI at week 52 and 'No' infers percentage of participants who did not achieve ≥ 10% reduction in their baseline (week 0) BMI at week 52.
SecondaryPercentage of Participants With no Increase in BMI SDS at Week 16At week 16
Percentage of participants with no increase in BMI SDS at week 16 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 16 and 'No' infers percentage of participants with increase in BMI SDS at week 16.
SecondaryPercentage of Participants With no Increase in BMI SDS at Week 52At week 52
Percentage of participants with no increase in BMI SDS at week 52 is presented. In below table, 'Yes' infers percentage of participants with no increase in BMI SDS at week 52 and 'No' infers percentage of participants with increase in BMI SDS at week 52.
SecondaryChange in BMI From Baseline at Week 16Week 0, week 16Change in body mass index (BMI) from baseline to week 16 is presented.
SecondaryChange in BMI From Baseline at Week 52Week 0, week 52Change in body mass index (BMI) from baseline to week 52 is presented.
SecondaryChange in Body Weight (Kilogram (kg)) From Baseline at Week 16Week 0, week 16Change in body weight (kg) from baseline to week 16 is presented.
SecondaryChange in Body Weight (kg) From Baseline at Week 52Week 0, week 52Change in body weight (kg) from baseline to week 52 is presented.
SecondaryChange in Body Weight (Pounds (lb)) From Baseline at Week 16Week 0, week 16Change in body weight (lb) from baseline to week 16 is presented.
SecondaryChange in Body Weight (lb) From Baseline at Week 52Week 0, week 52Change in body weight (lb) from baseline to week 52 is presented.
SecondaryChange in Body Weight (Percentage [%]) From Baseline at Week 16Week 0, week 16Change in body weight (%) from baseline to week 16 is presented.
SecondaryChange in Body Weight (%) From Baseline at Week 52Week 0, week 52Change in body weight (%) from baseline to week 52 is presented.
SecondaryChange in Waist Circumference From Baseline at Week 16Week 0, week 16Change in waist circumference from baseline to week 16 is presented.
SecondaryChange in Waist Circumference From Baseline at Week 52Week 0, week 52Change in waist circumference from baseline to week 52 is presented.
SecondaryChange in Waist-to-hip Circumference Ratio From Baseline at Week 16Week 0, week 16Change in waist-to-hip circumference ratio from baseline to week 16 is presented.
SecondaryChange in Waist-to-hip Circumference Ratio From Baseline at Week 52Week 0, week 52Change in waist-to-hip circumference ratio from baseline to week 52 is presented.

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.

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