Childhood ObesityADMIRENCT05125822
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
A study testing Meal replacement and lifestyle modification in people with Childhood Obesity, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Meal replacement and lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2023to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 11 to less than 16 years old
- BMI > 30 kg/m^2 or 95th BMI percentile
- Tanner stage 2, 3, or 4
Who cannot join
- Tanner stage 1 and 5
- Prior bariatric surgery
- Current or recent (< 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Monogenic and hypothalamic obesity
- Polycystic ovary syndrome (diagnosed by a physician)
- Pregnancy or planned pregnancy
Show all 12Show fewer
- Current use of supplemental hormones
- Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder
- Type 1 or 2 diabetes
- Treatment with growth hormones
- Thyroid disease/problem
- Has had cancer in the last 10 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Justin R Ryder, 3148826838, jryder@luriechildrens.org
Justin Ryder, PhD
About this study
In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables.
Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.
Read the detailed description
Individuals who are found to be eligible to participate will have two study interventions: An 8-week meal replacement therapy period in which they are asked to reduce their BMI by >5%. Participants will be asked to strictly follow the individually-prescribed eating regimen which will include meal replacement shakes and/or frozen meals to be used for breakfast and lunch. For dinner, the study will provide pre-packaged frozen entrée meals to be consumed with two servings of fruit and three servings of vegetables per day. Meal replacement compliance will be assessed by requiring participants to maintain a dietary log throughout the study. The percentage of days for which the protocol was followed (no additional calories consumed) will serve as the primary metric of compliance.
Participants will also receive a standardized lifestyle/behavioral modification counseling every 2 weeks throughout the entire study, which will be delivered at each in-person study visit and via virtual platform of phone when there is no in-person study visit scheduled. The lifestyle curriculum will incorporate evidence-based behavior change principles including dietary modification, energy expenditure modification, behavior modification and family involvement and support. To ensure fidelity and adherence to the delivery protocol, a manual will be developed for each session that trained staff will follow when administering the curriculum.
- Conditions
- Childhood Obesity
- Being tested
- Meal replacement and lifestyle modification
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal replacement and lifestyle modificationOther
Meal replacement and lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| Meal Replacement and Lifestyle Therapy | Experimental | 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. Receives: Other: Meal replacement and lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)
We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.
Measured: 17 weeks.
Change in ghrelin
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.
Measured: 17 weeks.
Change in gastric inhibitory polypeptide
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start26 Aug 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group study that will consist of two interventions: an 8-week meal replacement therapy period in which participants are asked to reduce their body mass index (BMI) by \>/= 5% by following a prescribed eating regimen and standardized lifestyle/behavior modification counseling which will occur every 2 weeks throughout the study.
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Ryder, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Justin Ryder, PhD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125822
- Sponsor's protocol ID
- PEDS-2021-30024
- Other IDs
- STUDY00014425
- Acronym
- ADMIRE
- Status last verified
- May 2026
- First submitted
- 8 Nov 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
- ClinicalTrials.gov ID
- NCT05125822
- Acronym / sponsor ID
- ADMIRE / PEDS-2021-30024
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables.
Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.
Detailed description
Individuals who are found to be eligible to participate will have two study interventions: An 8-week meal replacement therapy period in which they are asked to reduce their BMI by >5%. Participants will be asked to strictly follow the individually-prescribed eating regimen which will include meal replacement shakes and/or frozen meals to be used for breakfast and lunch. For dinner, the study will provide pre-packaged frozen entrée meals to be consumed with two servings of fruit and three servings of vegetables per day. Meal replacement compliance will be assessed by requiring participants to maintain a dietary log throughout the study. The percentage of days for which the protocol was followed (no additional calories consumed) will serve as the primary metric of compliance.
Participants will also receive a standardized lifestyle/behavioral modification counseling every 2 weeks throughout the entire study, which will be delivered at each in-person study visit and via virtual platform of phone when there is no in-person study visit scheduled. The lifestyle curriculum will incorporate evidence-based behavior change principles including dietary modification, energy expenditure modification, behavior modification and family involvement and support. To ensure fidelity and adherence to the delivery protocol, a manual will be developed for each session that trained staff will follow when administering the curriculum.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group study that will consist of two interventions: an 8-week meal replacement therapy period in which participants are asked to reduce their body mass index (BMI) by >/= 5% by following a prescribed eating regimen and standardized lifestyle/behavior modification counseling which will occur every 2 weeks throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Meal Replacement and Lifestyle Therapy | Experimental | Other: Meal replacement and lifestyle modificationParticipants 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. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 11 to less than 16 years old
- BMI > 30 kg/m^2 or 95th BMI percentile
- Tanner stage 2, 3, or 4
Key exclusion criteria (12 listed)
- Tanner stage 1 and 5
- Prior bariatric surgery
- Current or recent (< 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Monogenic and hypothalamic obesity
- Polycystic ovary syndrome (diagnosed by a physician)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal replacement and lifestyle modificationMeal replacement and lifestyle modification | Other | Meal Replacement and Lifestyle Therapy |
Primary outcome
Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)
Time frame: 17 weeks.
We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.
Change in ghrelin
Time frame: 17 weeks.
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.
Change in gastric inhibitory polypeptide
Time frame: 17 weeks
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Ryder, PhD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal replacement and lifestyle modification in people with Childhood Obesity, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Ryder, PhD (3148826838, jryder@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fat mass regain after initial weight loss with meal replacement therapy (MRT) (time frame: 17 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.