SMART Use of Medication for the Treatment of Adolescent Severe Obesity

University of Minnesota150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Adolescent Obesity

Interventions

Lifestyle Modification Therapy (LSMT)BEHAVIORAL

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.

Phentermine PillDRUG

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Percent Change in Body Mass Index (BMI)

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

Time frame: Baseline to Week 48

Data from ClinicalTrials.gov

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