N/A
N=126
Weight Loss With Meal-Replacement Therapy in Teens
Obesity, Severe · Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03137433 ↗Enrolled (actual)
126
Serious AEs
3.2%
Results posted
Mar 2024
Primary outcome: Primary: Body Mass Index (From Baseline to 1-year) — -0.9; -6.6 Percent change in BMI
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Meal-replacement Therapy (Dietary_supplement)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (From Baseline to 1-year) |
-0.9; -6.6 | — |
| SECONDARY Total Fat Mass (kg) |
-1.3; -6.1 | — |
| SECONDARY Carotid-radial Pulse Wave Velocity (m/s) |
-0.1; 0.1 | — |
| SECONDARY Impact of Weight-related on Quality of Life |
3.2; 5.2 | — |
| SECONDARY Systolic Blood Pressure |
-3.1; -2.1 | — |
| SECONDARY Diastolic Blood Pressure |
-0.3; 0.1 | — |
| SECONDARY Total Cholesterol |
153.9; 158.6 | — |
| SECONDARY HDL |
43.6; 44.0 | — |
| SECONDARY LDL |
89.1; 89.3 | — |
| SECONDARY Triglyceride/HDL Cholesterol Ratio |
-0.2; -0.5 | — |
| SECONDARY Total Glucose |
87.3; 87.4 | — |
| SECONDARY Insulin |
28.3; 34.2 | — |
Summary
This study seeks to examine whether meal-replacement therapy is able to enhance weight loss among teens with severe obesity. In addition, we are also interested in examining the degree of weight loss needed to improve important cardiometabolic risk factors among adolescents.
Eligibility Criteria
Inclusion Criteria
- BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
- 13-17 years old
Exclusion Criteria
- Type 1 or 2 diabetes mellitus
- Previous (within 6 months) or current use of meal replacements
- Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
- If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
- Previous bariatric surgery
- If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
- If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months
- History of treatment with growth hormone
- Neurodevelopmental disorder severe enough to impair ability to comply with study protocol
- Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse
- Females: currently pregnant or planning to become pregnant
- Tobacco use
- Bulimia nervosa
- Endorsement of vomiting, laxative use, and/or diuretic use for weight control (EDE-Q)
- Binge eating disorder
- Neurological disorder
- Hypothalamic obesity
- Obesity associated with genetic disorder (monogenetic obesity)
- Hyperthyroidism or uncontrolled hypothyroidism
- History of cholelithiasis
Data sourced from ClinicalTrials.gov (NCT03137433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.