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Meal-replacement Therapy for Childhood Obesity

N/A
Waitlist Available
Led By Aaron Kelly, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial will test whether meal-replacement therapy can help teens with severe obesity lose weight and improve their health.

Eligible Conditions
  • Childhood Obesity
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Mass Index (From Baseline to 1-year)
Secondary outcome measures
Carotid-radial Pulse Wave Velocity (m/s)
Diastolic Blood Pressure
HDL
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Meal-Replacements PlusExperimental Treatment1 Intervention
Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data). This group will be provided additional information to go along with meal-replacements.
Group II: Meal-ReplacementsExperimental Treatment1 Intervention
Participants will be asked to strictly follow the individually-prescribed eating regimen, which will include shakes (breakfast and lunch) and pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables per day. Daily caloric allotment will be tailored for each individual (number of shakes and frozen meals) by calculating the average daily caloric deficit necessary to achieve negative energy balance (using the metabolic rate/energy expenditure data).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meal-replacement Therapy
2018
N/A
~130

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,619 Total Patients Enrolled
Aaron Kelly, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
263 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept patients of mature age?

"This research initiative seeks adolescent participants between the ages of 13 and 17 years old."

Answered by AI

Are there any vacancies left in this medical experiment for participants?

"This clinical trial is not presently open for recruitment, with the latest update to its information having been made on October 15th 2022. Nonetheless, there are 1164 different trials that are actively recruiting participants at this time."

Answered by AI

Who meets the eligibility requirements to participate in this trial?

"Up to 126 minors suffering from pediatric obesity can join this trial. Eligibility is contingent on having a BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2, with an age of 13-17 years old."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Weight Loss With Meal-Replacement Therapy in Teens
2018. "Weight Loss With Meal-Replacement Therapy in Teens". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03137433.
~17 spots leftby Apr 2025
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