Obesity, SevereNCT03137433
Weight Loss With Meal-Replacement Therapy in Teens
A study testing Meal-replacement Therapy in people with Obesity, Severe and Pediatric Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Severe, Pediatric Obesity
- What is being tested?
- Meal-replacement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
- 13-17 years old
Who cannot join
- Type 1 or 2 diabetes mellitus
- Previous (within 6 months) or current use of meal replacements
- Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
- If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
- Previous bariatric surgery
- If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
Show all 20Show fewer
- If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months
- History of treatment with growth hormone
- Neurodevelopmental disorder severe enough to impair ability to comply with study protocol
- Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse
- Females: currently pregnant or planning to become pregnant
- Tobacco use
- Bulimia nervosa
- Endorsement of vomiting, laxative use, and/or diuretic use for weight control (EDE-Q)
- Binge eating disorder
- Neurological disorder
- Hypothalamic obesity
- Obesity associated with genetic disorder (monogenetic obesity)
- Hyperthyroidism or uncontrolled hypothyroidism
- History of cholelithiasis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity
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.
Read the detailed description
This study will involve 130 adolescents (ages 13-17 years old) participating in meal replacement therapy and will last one year (12 months).
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). Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.
We will measure the changes in resting metabolic rate, traditional clinical risk markers (TG, HDL-c, LDL-c, TC, glucose, insulin), vascular function, weight-related quality of life, and physical activity.
- Conditions
- Obesity, Severe, Pediatric Obesity
- Being tested
- Meal-replacement Therapy
- Keywords
- Weight loss, Cardiometabolic, Meal-replacement therapy
- Medical subject headings
- Obesity, Morbid, Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal-replacement TherapyDietary supplement
We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
| Study group | Role | What they receive |
|---|---|---|
| Meal-Replacements | Experimental | 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). Receives: Dietary Supplement: Meal-replacement Therapy |
| Meal-Replacements Plus | Experimental | 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. Receives: Dietary Supplement: Meal-replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (From Baseline to 1-year)
Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)
Measured: 52 weeks
Secondary outcomes (11)
Total Fat Mass (kg)
Change in fat mass from randomization to week 52
Measured: 52 Weeks
Carotid-radial Pulse Wave Velocity (m/s)
Change in measure of arterial stiffness (from baseline to 1-year)
Measured: 52 weeks
Impact of Weight-related on Quality of Life
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.
Measured: 52 weeks
Systolic Blood Pressure
Change in systolic blood pressure (from baseline to 1-year)
Measured: 52 weeks
Diastolic Blood Pressure
Change in diastolic blood pressure (from baseline to 1-year)
Measured: 52 weeks
Total Cholesterol
Total cholesterol (mg/dL)
Measured: 52 Weeks
HDL
High Density Lipoprotein (mg/dL)
Measured: 52 Weeks
LDL
Low Density Lipoprotein (mg/dL)
Measured: 52 Weeks
Triglyceride/HDL Cholesterol Ratio
Triglyceride/HDL cholesterol ratio (from baseline to 1-year)
Measured: 52 weeks
Total Glucose
Total Glucose (mg/dL)
Measured: 52 Weeks
Insulin
Insulin (mU/dL)
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start2 Jan 2018
- Primary completion30 Sep 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, SevereStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Kelly, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137433
- Sponsor's protocol ID
- PEDS-2017-25609
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2017
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gross AC, Freese RL, Bensignor MO, Bomberg EM, Dengel DR, Fox CK, Rudser KD, Ryder JR, Bramante CT, Raatz S, Lim F, Hur C, Kelly AS. Financial Incentives and Treatment Outcomes in Adolescents With Severe Obesity: A Randomized Clinical Trial. JAMA Pediatr. 2024 Aug 1;178(8):753-762. doi: 10.1001/jamapediatrics.2024.1701.
PubMed 38884967
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity
- ClinicalTrials.gov ID
- NCT03137433
- Acronym / sponsor ID
- PEDS-2017-25609
- Conditions
- Obesity, Severe, Pediatric Obesity
- Keywords
- Weight loss, Cardiometabolic, Meal-replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will involve 130 adolescents (ages 13-17 years old) participating in meal replacement therapy and will last one year (12 months).
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). Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.
We will measure the changes in resting metabolic rate, traditional clinical risk markers (TG, HDL-c, LDL-c, TC, glucose, insulin), vascular function, weight-related quality of life, and physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal-Replacements | Experimental | Dietary Supplement: Meal-replacement TherapyParticipants 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). |
| Meal-Replacements Plus | Experimental | Dietary Supplement: Meal-replacement TherapyParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2
- 13-17 years old
Key exclusion criteria (20 listed)
- Type 1 or 2 diabetes mellitus
- Previous (within 6 months) or current use of meal replacements
- Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)
- If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months
- Previous bariatric surgery
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 TherapyWe seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. | Dietary supplement | Meal-Replacements, Meal-Replacements Plus |
Primary outcome
Body Mass Index (From Baseline to 1-year)
Time frame: 52 weeks
Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)
11 secondary outcomes
Total Fat Mass (kg)
Time frame: 52 Weeks
Carotid-radial Pulse Wave Velocity (m/s)
Time frame: 52 weeks
Impact of Weight-related on Quality of Life
Time frame: 52 weeks
Systolic Blood Pressure
Time frame: 52 weeks
Diastolic Blood Pressure
Time frame: 52 weeks
Total Cholesterol
Time frame: 52 Weeks
HDL
Time frame: 52 Weeks
LDL
Time frame: 52 Weeks
Triglyceride/HDL Cholesterol Ratio
Time frame: 52 weeks
Total Glucose
Time frame: 52 Weeks
Insulin
Time frame: 52 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38884967Gross AC, Freese RL, Bensignor MO, Bomberg EM, Dengel DR, Fox CK, Rudser KD, Ryder JR, Bramante CT, Raatz S, Lim F, Hur C, Kelly AS. Financial Incentives and Treatment Outcomes in Adolescents With Severe Obesity: A Randomized Clinical Trial. JAMA Pediatr. 2024 Aug 1;178(8):753-762. doi: 10.1001/jamapediatrics.2024.1701.
- Individual participant dataSharing planned: No
Related trials for Obesity, Severe
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
Active, not recruiting
Time-restricted Eating Among Pregnant Females With Severe Obesity
Obesity, Morbid, Time Restricted Eating
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. This study is not recruiting at the moment.
Aaron Kelly, PhD principal investigator
University of Minnesota
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 Therapy in people with Obesity, Severe and Pediatric Obesity, run by University of Minnesota 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 2 inclusion and 20 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: finished, as of the sponsor's last update on 22 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (From Baseline to 1-year) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137433, which also lists 1 linked publication.
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 22 Mar 2024.