NCT03137433

Weight Loss With Meal-Replacement Therapy in Teens

Completed NA Results posted Last updated 22 March 2024

What this trial tests

NA trial testing Meal-replacement Therapy in Obesity, Severe in 126 participants. Completed in 30 April 2023.

Timeline

2 January 2018

Primary endpoint
30 September 2022

30 April 2023

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	2 January 2018
Primary completion	30 September 2022
Estimated completion	30 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Meal-replacement Therapy

Conditions studied

• Obesity, Severe — all drugs for Obesity, Severe →
• Pediatric Obesity — all drugs for Pediatric Obesity →

Sponsor

University of Minnesota

Who can join

Adults 13 to 17, any sex, with Obesity, Severe or Pediatric Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Mass Index (From Baseline to 1-year) Primary · 52 weeks

Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)

Group	Value	95% CI
Meal-Replacements	-0.9	± 1.3
Meal-Replacements Plus	-6.6	± 1.6

Total Fat Mass (kg) Secondary · 52 Weeks

Change in fat mass from randomization to week 52

Group	Value	95% CI
Meal-Replacements	-1.3	± 1.5
Meal-Replacements Plus	-6.1	± 1.5

Carotid-radial Pulse Wave Velocity (m/s) Secondary · 52 weeks

Change in measure of arterial stiffness (from baseline to 1-year)

Group	Value	95% CI
Meal-Replacements	-0.1	± 0.1
Meal-Replacements Plus	0.1	± 0.2

Impact of Weight-related on Quality of Life Secondary · 52 weeks

Impact of Weight-related on Quality of Life Total Transformed Score (from physical comfort transformed score, body self esteem transformed score, social life transformed score, and family relations transformed score). Scores range from 0 to 100 with 100 representing the best quality of life.

Group	Value	95% CI
Meal-Replacements	3.2	± 2.5
Meal-Replacements Plus	5.2	± 3.1

Systolic Blood Pressure Secondary · 52 weeks

Change in systolic blood pressure (from baseline to 1-year)

Group	Value	95% CI
Meal-Replacements	-3.1	± 1.7
Meal-Replacements Plus	-2.1	± 1.7

Diastolic Blood Pressure Secondary · 52 weeks

Change in diastolic blood pressure (from baseline to 1-year)

Group	Value	95% CI
Meal-Replacements	-0.3	± 1.4
Meal-Replacements Plus	0.1	± 1.5

Total Cholesterol Secondary · 52 Weeks

Total cholesterol (mg/dL)

Group	Value	95% CI
Meal-Replacements	153.9	± 30
Meal-Replacements Plus	158.6	± 32

HDL Secondary · 52 Weeks

High Density Lipoprotein (mg/dL)

Group	Value	95% CI
Meal-Replacements	43.6	± 9
Meal-Replacements Plus	44.0	± 10

LDL Secondary · 52 Weeks

Low Density Lipoprotein (mg/dL)

Group	Value	95% CI
Meal-Replacements	89.1	± 29
Meal-Replacements Plus	89.3	± 30

Triglyceride/HDL Cholesterol Ratio Secondary · 52 weeks

Triglyceride/HDL cholesterol ratio (from baseline to 1-year)

Group	Value	95% CI
Meal-Replacements	-0.2	± 0.3
Meal-Replacements Plus	-0.5	± 0.3

Total Glucose Secondary · 52 Weeks

Total Glucose (mg/dL)

Group	Value	95% CI
Meal-Replacements	87.3	± 9
Meal-Replacements Plus	87.4	± 6

Insulin Secondary · 52 Weeks

Insulin (mU/dL)

Group	Value	95% CI
Meal-Replacements	28.3	± 16
Meal-Replacements Plus	34.2	± 25

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Meal-Replacements

Serious: 3/63 (5%)

Deaths: 0/63

Meal-Replacements Plus

Serious: 1/63 (2%)

Deaths: 0/63

Serious adverse events (4 terms)

Reaction	System	Meal-Replacements	Meal-Replacements Plus
Exacerbation of Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Suicide attempt	Psychiatric disorders	—	—
Overdose	Psychiatric disorders	—	—
Acquired pneumonia and E-cigarette associated lung injury (EVALI)	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Meal-Replacements	Meal-Replacements Plus
Self induced vomiting	Psychiatric disorders	—	—
Self report of taking laxatives	Psychiatric disorders	—	—

Most-reported serious reactions: Exacerbation of Asthma, Suicide attempt, Overdose, Acquired pneumonia and E-cigarette associated lung injury (EVALI).

Data from ClinicalTrials.gov NCT03137433 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Financial Incentives and Treatment Outcomes in Adolescents With Severe Obesity: A Randomized Clinical Trial.
   Gross AC, Freese RL, Bensignor MO, Bomberg EM, et al · · 2024 · cited 6× · PMID 38884967 · DOI 10.1001/jamapediatrics.2024.1701
2. Prediction of resting energy expenditure for adolescents with severe obesity: A multi-centre analysis.
   Rydin AA, Severn C, Pyle L, Morelli N, et al · · 2024 · cited 1× · PMID 38658523 · DOI 10.1111/ijpo.13123