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SMART Use of Medication for the Treatment of Adolescent Severe Obesity (SMART)

Primary Purpose

Adolescent Obesity

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Modification Therapy (LSMT)
Phentermine Pill
Topiramate Pill
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Obesity

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LSMT x 12 weeks

LSMT x 24 weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent change in body mass index (BMI)
Body mass index is a measure of body fat based on height and weight.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2019
Last Updated
October 2, 2023
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04007393
Brief Title
SMART Use of Medication for the Treatment of Adolescent Severe Obesity
Acronym
SMART
Official Title
SMART Use of Medication for the Treatment of Adolescent Severe Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
2-staged sequential multiple assignment randomized trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LSMT x 12 weeks
Arm Type
Other
Arm Description
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at T=12 weeks: if body mass index (BMI) is down 5% at T=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 T=12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at T=24 weeks. At T=24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study (i.e. for another 24 weeks); if BMI is not down by 5% at T=24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study (i.e. for another 24 weeks).
Arm Title
LSMT x 24 weeks
Arm Type
Other
Arm Description
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at T=24 weeks: if body mass index (BMI) is down 5% at T=24 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 24 weeks); if BMI is not down 5% at T=24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at T=36 weeks. At T=36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study (i.e. for another 12 weeks); if BMI is not down by 5% at T=36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study (i.e. for another 12 weeks).
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification Therapy (LSMT)
Intervention Description
LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of 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 delivery this therapy which consists of counseling using education, goal setting and barrier reduction. Topics covered will include calories, tracking, healthy food choices, reducing high fat, added sugar foods, setting goals and portions, changing the quality of your diet, volumetrics, purposeful activity, quick and easy meals, problem solving, food cues and eating patterns, emotional eating, accurate tracking, eating away from home, unhelpful thoughts, structured menus and the role of protein, social cues, managing stress, slips and relapse prevention, long-term physical activity and overcoming obstacles, high-risk situation and keys to success, motivation and looking to the future (long-term plans).
Intervention Type
Drug
Intervention Name(s)
Phentermine Pill
Intervention Description
Phentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT depending on their random assignment. 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.
Intervention Type
Drug
Intervention Name(s)
Topiramate Pill
Intervention Description
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. Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
Primary Outcome Measure Information:
Title
Percent change in body mass index (BMI)
Description
Body mass index is a measure of body fat based on height and weight.
Time Frame
Baseline, 12-, 24-, 36-, and 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Fox, MD, MPH
Phone
(612)626-6616
Email
lusc0001@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Fox, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Fox, MD
Phone
612-626-6616
Email
lusc0001@umn.edu
First Name & Middle Initial & Last Name & Degree
Nina Jacobs
Phone
(612)624-3137
Email
njacobs@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

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