Obesity, Severe, Pediatric Obesity
Conditions
Keywords
Weight loss, Cardiometabolic, Meal-replacement therapy
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTMeal-replacement Therapy
We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2 * 13-17 years old
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (From Baseline to 1-year) | 52 weeks | Percent change in body mass index (BMI) from baseline to 1-year (kg/m2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid-radial Pulse Wave Velocity (m/s) | 52 weeks | Change in measure of arterial stiffness (from baseline to 1-year) |
| Impact of Weight-related on Quality of Life | 52 weeks | 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. |
| Systolic Blood Pressure | 52 weeks | Change in systolic blood pressure (from baseline to 1-year) |
| Diastolic Blood Pressure | 52 weeks | Change in diastolic blood pressure (from baseline to 1-year) |
| Total Cholesterol | 52 Weeks | Total cholesterol (mg/dL) |
| Total Fat Mass (kg) | 52 Weeks | Change in fat mass from randomization to week 52 |
| LDL | 52 Weeks | Low Density Lipoprotein (mg/dL) |
| Triglyceride/HDL Cholesterol Ratio | 52 weeks | Triglyceride/HDL cholesterol ratio (from baseline to 1-year) |
| Total Glucose | 52 Weeks | Total Glucose (mg/dL) |
| Insulin | 52 Weeks | Insulin (mU/dL) |
| HDL | 52 Weeks | High Density Lipoprotein (mg/dL) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| 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. | 63 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Moved out of study area | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Too far out of window due to COVID | 0 | 1 |
| Overall Study | Withdrawal by Subject | 11 | 11 |
Baseline characteristics
| Characteristic | Meal-Replacements | Meal-Replacements Plus | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 63 Participants | 63 Participants | 126 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 55 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 10 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 43 Participants | 40 Participants | 83 Participants |
| Sex: Female, Male Female | 35 Participants | 38 Participants | 73 Participants |
| Sex: Female, Male Male | 28 Participants | 25 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 9 / 63 | 6 / 63 |
| serious Total, serious adverse events | 3 / 63 | 1 / 63 |
Outcome results
Primary
Body Mass Index (From Baseline to 1-year)
Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Body Mass Index (From Baseline to 1-year) | -0.9 Percent change in BMI | Standard Deviation 1.3 |
| Meal-Replacements Plus | Body Mass Index (From Baseline to 1-year) | -6.6 Percent change in BMI | Standard Deviation 1.6 |
Secondary
Carotid-radial Pulse Wave Velocity (m/s)
Change in measure of arterial stiffness (from baseline to 1-year)
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Carotid-radial Pulse Wave Velocity (m/s) | -0.1 m/s | Standard Deviation 0.1 |
| Meal-Replacements Plus | Carotid-radial Pulse Wave Velocity (m/s) | 0.1 m/s | Standard Deviation 0.2 |
Secondary
Diastolic Blood Pressure
Change in diastolic blood pressure (from baseline to 1-year)
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Diastolic Blood Pressure | -0.3 mm Hg | Standard Deviation 1.4 |
| Meal-Replacements Plus | Diastolic Blood Pressure | 0.1 mm Hg | Standard Deviation 1.5 |
Secondary
HDL
High Density Lipoprotein (mg/dL)
Time frame: 52 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | HDL | 43.6 mg/dL | Standard Deviation 9 |
| Meal-Replacements Plus | HDL | 44.0 mg/dL | Standard Deviation 10 |
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.
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Impact of Weight-related on Quality of Life | 3.2 score on a scale | Standard Deviation 2.5 |
| Meal-Replacements Plus | Impact of Weight-related on Quality of Life | 5.2 score on a scale | Standard Deviation 3.1 |
Secondary
Insulin
Insulin (mU/dL)
Time frame: 52 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Insulin | 28.3 mU/dL | Standard Deviation 16 |
| Meal-Replacements Plus | Insulin | 34.2 mU/dL | Standard Deviation 25 |
Secondary
LDL
Low Density Lipoprotein (mg/dL)
Time frame: 52 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | LDL | 89.1 mg/dL | Standard Deviation 29 |
| Meal-Replacements Plus | LDL | 89.3 mg/dL | Standard Deviation 30 |
Secondary
Systolic Blood Pressure
Change in systolic blood pressure (from baseline to 1-year)
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Systolic Blood Pressure | -3.1 mm Hg | Standard Deviation 1.7 |
| Meal-Replacements Plus | Systolic Blood Pressure | -2.1 mm Hg | Standard Deviation 1.7 |
Secondary
Total Cholesterol
Total cholesterol (mg/dL)
Time frame: 52 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Total Cholesterol | 153.9 mg/dL | Standard Deviation 30 |
| Meal-Replacements Plus | Total Cholesterol | 158.6 mg/dL | Standard Deviation 32 |
Secondary
Total Fat Mass (kg)
Change in fat mass from randomization to week 52
Time frame: 52 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Total Fat Mass (kg) | -1.3 Kg | Standard Deviation 1.5 |
| Meal-Replacements Plus | Total Fat Mass (kg) | -6.1 Kg | Standard Deviation 1.5 |
Secondary
Total Glucose
Total Glucose (mg/dL)
Time frame: 52 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Total Glucose | 87.3 mg/dL | Standard Deviation 9 |
| Meal-Replacements Plus | Total Glucose | 87.4 mg/dL | Standard Deviation 6 |
Secondary
Triglyceride/HDL Cholesterol Ratio
Triglyceride/HDL cholesterol ratio (from baseline to 1-year)
Time frame: 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meal-Replacements | Triglyceride/HDL Cholesterol Ratio | -0.2 TG/HDL cholesterol ratio | Standard Deviation 0.3 |
| Meal-Replacements Plus | Triglyceride/HDL Cholesterol Ratio | -0.5 TG/HDL cholesterol ratio | Standard Deviation 0.3 |