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Meal Replacement and Lifestyle Modification for Obesity (ADMIRE Trial)

N/A

Recruiting

Led By Justin Ryder, 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

Tanner stage 2, 3, or 4

11 to less than 16 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 17 weeks

Awards & highlights

ADMIRE Trial Summary

This trial will investigate why people who lose weight often regain it and whether hormones play a role. Participants will drink shakes & eat calorie-controlled frozen meals for 10 weeks, & have 13 visits over 35 weeks. Fruits & vegetables provided by participants.

Who is the study for?

This trial is for young individuals aged 11 to less than 16 with severe obesity, measured by a BMI >30 kg/m^2 or above the 95th percentile. They should be in the middle stages of puberty (Tanner stage 2-4). Those who are pregnant, have had bariatric surgery, use certain weight-loss drugs, have specific health conditions like polycystic ovary syndrome or thyroid issues, cancer within the last decade, hormonal treatments, genetic obesity forms or diagnosed eating disorders can't participate.Check my eligibility

What is being tested?

The study tests if meal replacements and lifestyle changes affect why youth regain weight after dieting. Participants will replace two meals with shakes and eat a calorie-controlled dinner for a period followed by observation. The goal is to understand hormone roles in weight regain post-dieting.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort from dietary changes and possible nutritional imbalances due to altered eating patterns during the meal replacement phase.

ADMIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My body is in the middle stages of puberty.

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I am between 11 and 15 years old.

ADMIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 17 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~17 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 17 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

Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)

Change in gastric inhibitory polypeptide

Change in ghrelin

ADMIRE Trial Design

1Treatment groups

Experimental Treatment

Group I: Meal Replacement and Lifestyle TherapyExperimental Treatment1 Intervention

Participants in this study will have an 8-week meal replacement therapy period in which they are asked to reduce their BMI by 5% by following a prescribed eating regimen consisting of meal replacement shakes and/or frozen meals for breakfast and lunch. For dinner they will consume a pre-packaged frozen entree to be consumed with two servings of fruit and three servings of vegetables per day. Participants will also have lifestyle/behavioral modification counseling every 2 weeks throughout the entire study.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,715 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,188,870 Total Patients Enrolled

Justin Ryder, PhDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

2 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Meal replacement and lifestyle modification (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05125822 — N/A

Childhood Obesity Research Study Groups: Meal Replacement and Lifestyle Therapy

Childhood Obesity Clinical Trial 2023: Meal replacement and lifestyle modification Highlights & Side Effects. Trial Name: NCT05125822 — N/A

Meal replacement and lifestyle modification (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05125822 — N/A

Frequently Asked Questions

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

Is the age restriction on this trial limited to those over 30 years of age?

"This clinical trial requires that participants are between 11 and 15 years old. There are 240 studies available for people below the age of majority, while 627 studies are open to those aged over 65."

Answered by AI

How many participants are signing up for this trial?

"Correct. Clinicaltrials.gov records show that this trial, which was initially listed on August 26th 2023, is still actively recruiting. An estimated 260 participants must be found to satisfy the requirements of the study from a single medical site."

Answered by AI

Are there any enrollment opportunities available for this trial?

"This research endeavour is presently recruiting participants, as denoted on the clinicaltrials.gov portal which was updated most recently on August 30th of this year - it had first been published 26 days prior."

Answered by AI

What criteria must individuals meet to be eligible for this trial?

"This trial is enrolling 260 young people between 11 and 15 years old who are currently struggling with childhood obesity. Participants must meet the following qualifications: age 11 to less than 16, BMI > 30 kg/m^2 or 95th percentile in terms of BMI, Tanner stage 2-4."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

2023. "Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05125822.