SMART Use of Medication for the Treatment of Adolescent Severe Obesity
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Percent Change in Body Mass Index (BMI)
Study Overview
Brief Summary
This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.
Detailed Description
This project is studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. All participants start with a lifestyle modification program and some participants may also receive study medication.Participants must be 12-17 years of age and carry extra weight. The program will last for 48 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
At baseline, each participant will be randomized 1:1 to either the 12-week (Arm 1) or 24-week (Arm 2) response assessment to LSMT. This randomization will be blinded to the participant, investigator, and outcomes assessor for the duration of the study; i.e. up until 48 weeks.
The second randomization includes only those participants who are non-responders to phentermine+LSMT. Each non-responder to phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Participants, investigators, and outcomes assessors will be blinded to phentermine/placebo. The topiramate will be open label.
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of signed and dated informed assent form;
- •Provision of signed and dated informed parental consent form from at least 1 legal parent/guardian;
- •Stated willingness to comply with all study procedures and availability for the duration of the study;
- •BMI >/= 1.2 times the 95th percentile or BMI >/= 35 Kg/m2, whichever is lower;
- •Tanner stage >/= 2;
- •Male or female, aged 12-17 at time of consenting;
- •For females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (IUD), or implant) during study participation;
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion Criteria
- •Contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension;
- •Diabetes (type 1 or 2);
- •Presence of cardiac pacemaker;
- •Current or recent (<6 months prior to enrollment) use of weight loss medication(s);
- •Current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months;
- •Current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (ADHD) stimulants;
- •Seizure disorder (other than infantile febrile seizure);
- •Previous bariatric surgery;
- •Recent initiation of change in dose (< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s);
- •Tobacco use
- •History of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency;
- •Unstable depression or anxiety that has required hospitalization in the past year;
- •Any history of suicide attempt;
- •Suicidal ideation or self-harm within 12 months prior to enrollment;
- •Bicarbonate < 18 mmol/L;
- •Creatinine > 1.2 mg/dL;
- •History of cholelithiasis;
- •History of nephrolithiasis;
- •Untreated thyroid disorder;
- •Hyperthyroidism;
- •Breastfeeding
Arms & Interventions
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.
Intervention: Lifestyle Modification Therapy (LSMT) (Behavioral)
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.
Intervention: Placebo (Drug)
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.
Intervention: Lifestyle Modification Therapy (LSMT) (Behavioral)
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.
Intervention: Placebo (Drug)
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.
Intervention: Topiramate Pill (Drug)
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.
Intervention: Phentermine Pill (Drug)
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.
Intervention: Topiramate Pill (Drug)
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.
Intervention: Phentermine Pill (Drug)
Outcomes
Primary Outcomes
Percent Change in Body Mass Index (BMI)
Time Frame: Baseline to Week 48
The outcome values represent percent change in BMI from baseline to week 48.
Secondary Outcomes
No secondary outcomes reported