SMART 使用药物治疗青少年严重肥胖症 (SMART)

其他：LSMT 12

Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 36 weeks); if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study.

药品：托吡酯丸

在芬特明 + LSMT 12 周后未达到至少 5% BMI 降低的参与者将以 1:1 的比例重新随机分配至托吡酯 + 芬特明 + LSMT 或托吡酯 + 安慰剂 + LSMT。托吡酯的剂量将从前 7 天每天早上 50 毫克开始，然后增加到第 48 周每天早上 100 毫克。 在第 48 周结束时，逐渐减量为每天早上 50 毫克，持续 7 天，然后停药。

行为的：Lifestyle Modification Therapy (LSMT)

LSMT will consist of both in-person and by telephone sessions delivered throughout the 48-week intervention phase. Each session will last 30-60 minutes. A trained study coordinator (a registered dietician or someone trained by our registered dietician) will deliver therapy which consists of counseling using education, goal setting and barrier reduction. Participants will be randomized to receive LSMT for 12 or 24 weeks before a re-assessment of their BMI.

药品：Phentermine Pill

Phentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study (through week 48) along with their LSMT.

药品：Placebo

Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants will take a placebo pill every morning.

其他：LSMT 24

Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study. If BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (LSMT+phentermine) and undergo a second weight loss response assessment after 12 weeks. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with LSMT+Phentermine for the the remainder of study. If BMI is not down by 5% at 24 weeks, the participant will be randomized to LSMT+Phentermine+topiramate or LSMT+Topiramate+placebo for the duration of the study.

药品：托吡酯丸

在芬特明 + LSMT 12 周后未达到至少 5% BMI 降低的参与者将以 1:1 的比例重新随机分配至托吡酯 + 芬特明 + LSMT 或托吡酯 + 安慰剂 + LSMT。托吡酯的剂量将从前 7 天每天早上 50 毫克开始，然后增加到第 48 周每天早上 100 毫克。 在第 48 周结束时，逐渐减量为每天早上 50 毫克，持续 7 天，然后停药。

行为的：Lifestyle Modification Therapy (LSMT)

LSMT will consist of both in-person and by telephone sessions delivered throughout the 48-week intervention phase. Each session will last 30-60 minutes. A trained study coordinator (a registered dietician or someone trained by our registered dietician) will deliver therapy which consists of counseling using education, goal setting and barrier reduction. Participants will be randomized to receive LSMT for 12 or 24 weeks before a re-assessment of their BMI.

药品：Phentermine Pill

Phentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study (through week 48) along with their LSMT.

药品：Placebo

Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants will take a placebo pill every morning.

Percent Change in Body Mass Index (BMI)

The outcome values represent percent change in BMI from baseline to week 48.