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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

Must not have

Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder

Type 1 or 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 17 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.

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I have diabetes.

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I am currently taking supplemental hormones.

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My physical development is at the earliest or latest stage according to Tanner stages.

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I have had weight loss surgery in the past.

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I have a genetic form of obesity or obesity caused by brain signals.

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I am currently receiving growth hormone treatment.

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I have had cancer within the last 10 years.

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I have been diagnosed with polycystic ovary syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Change in gastric inhibitory polypeptide

Change in ghrelin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met