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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal-replacement Therapy | Dietary Supplement | We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (From Baseline to 1-year) | Percent change in body mass index (BMI) from baseline to 1-year (kg/m2) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fat Mass (kg) | Change in fat mass from randomization to week 52 | 52 Weeks |
| Carotid-radial Pulse Wave Velocity (m/s) | Change in measure of arterial stiffness (from baseline to 1-year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Kelly, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38884967 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Meal-Replacements | 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). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
| FG001 | Meal-Replacements Plus | 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; this group of individuals received financial incentives as part of their weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of participants randomized to each arm at the Baseline visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Meal-Replacements | 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). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age at study entry |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass Index (From Baseline to 1-year) | Percent change in body mass index (BMI) from baseline to 1-year (kg/m2) | Posted | Mean | Standard Deviation | Percent change in BMI | 52 weeks |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meal-Replacements | 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). Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization for asthma. Asthma was noted as a pre-existing condition at enrollment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self report of taking laxatives | Psychiatric disorders | Non-systematic Assessment | Taken from the Eating Disorder Examination-Questionnaire (EDEQ) question 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Kelly, PhD | University of Minnesota | 612-626-3492 | kelly105@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2022 | Sep 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2021 | Sep 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D063766 | Pediatric Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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. | 52 weeks |
| Systolic Blood Pressure | Change in systolic blood pressure (from baseline to 1-year) | 52 weeks |
| Diastolic Blood Pressure | Change in diastolic blood pressure (from baseline to 1-year) | 52 weeks |
| Total Cholesterol | Total cholesterol (mg/dL) | 52 Weeks |
| HDL | High Density Lipoprotein (mg/dL) | 52 Weeks |
| LDL | Low Density Lipoprotein (mg/dL) | 52 Weeks |
| Triglyceride/HDL Cholesterol Ratio | Triglyceride/HDL cholesterol ratio (from baseline to 1-year) | 52 weeks |
| Total Glucose | Total Glucose (mg/dL) | 52 Weeks |
| Insulin | Insulin (mU/dL) | 52 Weeks |
| Physician Decision |
|
| Moved out of study area |
|
| Too far out of window due to COVID |
|
| BG001 | Meal-Replacements Plus | 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 was provided additional information to go along with meal-replacements which was that they would be paid for their weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Meal-Replacements Plus |
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, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. |
|
|
| Secondary | Total Fat Mass (kg) | Change in fat mass from randomization to week 52 | Posted | Mean | Standard Deviation | Kg | 52 Weeks |
|
|
|
| Secondary | Carotid-radial Pulse Wave Velocity (m/s) | Change in measure of arterial stiffness (from baseline to 1-year) | Posted | Mean | Standard Deviation | m/s | 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 52 weeks |
|
|
|
| Secondary | Systolic Blood Pressure | Change in systolic blood pressure (from baseline to 1-year) | Posted | Mean | Standard Deviation | mm Hg | 52 weeks |
|
|
|
| Secondary | Diastolic Blood Pressure | Change in diastolic blood pressure (from baseline to 1-year) | Posted | Mean | Standard Deviation | mm Hg | 52 weeks |
|
|
|
| Secondary | Total Cholesterol | Total cholesterol (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 52 Weeks |
|
|
|
| Secondary | HDL | High Density Lipoprotein (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 52 Weeks |
|
|
|
| Secondary | LDL | Low Density Lipoprotein (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 52 Weeks |
|
|
|
| Secondary | Triglyceride/HDL Cholesterol Ratio | Triglyceride/HDL cholesterol ratio (from baseline to 1-year) | Posted | Mean | Standard Deviation | TG/HDL cholesterol ratio | 52 weeks |
|
|
|
| Secondary | Total Glucose | Total Glucose (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 52 Weeks |
|
|
|
| Secondary | Insulin | Insulin (mU/dL) | Posted | Mean | Standard Deviation | mU/dL | 52 Weeks |
|
|
|
| 0 |
| 63 |
| 3 |
| 63 |
| 9 |
| 63 |
| EG001 | Meal-Replacements Plus | 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, which was a financial incentive for weight loss. Meal-replacement Therapy: We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity. | 0 | 63 | 1 | 63 | 6 | 63 |
|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Overdose | Psychiatric disorders | Non-systematic Assessment |
|
| Acquired pneumonia and E-cigarette associated lung injury (EVALI) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
|
| Self induced vomiting | Psychiatric disorders | Non-systematic Assessment | Self report of making oneself sick based on the Eating Disorder Examination-Questionnaire, question 16. |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |