Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

(Number enrolled divided by number eligible) x 100

Number who do not complete the study divided by number enrolled

Presence of amphetamine in the urine at any study visit

Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit.

(Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100

(Baseline weight - weight at 12 weeks)/Baseline weight x 100

(Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks)

(Heart rate at baseline - Heart rate at 12 weeks)

Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks

Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks

Total cholesterol at baseline - Total cholesterol at 12 weeks

Triglycerides at baseline - Triglycerides at 12 weeks

LDL at baseline - LDL at 12 weeks

HDL at baseline - HDL at 12 weeks

ALT at baseline - ALT at 12 weeks

HbA1c at baseline - HbA1c at 12 weeks

% Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA

RMR at baseline - RMR at 12 weeks measured by indirect calorimetry

The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day.

The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period.

The adolescent/young adult will report subjective satiety 30 minutes after each meal and snack for 24 hours using a visual analogue slider scale (0= no fullness, 100 = most full) and this score will be averaged over the 24 hour period.

Validated questionnaire: Eating in the Absence of Hunger-Parent (EAH-P) completed by the parent/guardian about their adolescent/young adult. This measure has 14 items.

Each item is on a 5-point Likert scale ranging from 1= "never" to 5= "always". A higher score indicates more eating in the absence of hunger.

Total scores (minimum 14 to maximum 70) are calculated by taking the sum of the 14 items at each time point.

The mean change in total scores by group are presented.

The "Three-Factor Eating Questionnaire" will be completed by the adolescent/young adult. This is a 51-item questionnaire that assesses 3 eating behaviors: Cognitive Dietary Restraint, Disinhibited Eating, and Predisposition to hunger. Cognitive restraint was the domain of highest interest for this study and is reported here. Higher scores in each domain indicate more of each of those behaviors.

The cognitive restraint domain score is calculated by taking the average of the 21 items in that domain. Each of the 21 items has a score of 0 or 1.

MINIMUM mean score for this measure is: 0 and MAXIMUM mean score is 1. MINIMUM total score for this measure is: 0 and MAXIMUM total score is 21 (relevant to the "Full Range" in the data table below)

"Impact of Weight on Quality of Life-Kids" questionnaire will be completed by the adolescents age <=19.

Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.

Higher scores indicate higher quality of life.

"Impact of Weight on Quality of Life-Kids Parent Proxy" questionnaire will be completed by the parent of the adolescent/young adult.

Total and each of the 4 sub scales (Physical Comfort-6 items, Body Esteem-9 items, Social Life-6 items, and Family Relations-6 items) range from a minimum score of 0 to a maximum of 100.

Higher scores indicate higher quality of life.

PedsQL instrument will be completed by the adolescent/young adult. The CHANGE in total scale score is reported here. The total scale score at each time point ranges from a MIN of 0 to a MAX of 100.

Items are rated on a 0-4 scale. Items are reverse scored and linearly transformed to a 0-100 scale, such that 0=100, 1=75, 2=50, 3=25, and 4=0.

Scale Scores are calculated as the sum of the items over the number of items answered.

Higher scores indicated better health-related quality of life.

The adolescent/young adult will complete the 20-item Center for Epidemiologic Studies Depression Scale (CES-D).

Each item is rated on a 0 to 3 scale (positive items are reverse scored). Minimum score is 0 and maximum is 60. Higher scores indicate more depressive symptoms. Total score is calculated by summing each of the 20 individual items scores.

The participating family will be asked to complete a satisfaction questionnaire that will assess reasons for participation, experience during study visits, satisfaction with the effect of the study drug, ease of communication with study staff, and study burden.

The outcome presented here is the average of the parent and adolescent/young adult dyad's response to the statement: "My overall experience was positive" [1=Strongly disagree, 5=Strongly agree]