Weight Loss With Meal-Replacement Therapy in Teens
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 1/14/2018 |
| Start Date: | January 2, 2018 |
| End Date: | April 1, 2022 |
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.
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 142 adolescents (ages 13-17 years old) participating in meal
replacement therapy and will last one year (12 months), with a final follow-up visit 6 months
after meal replacement therapy ends.
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). Resting metabolic rate will be measured
and caloric allotment recalculated at each study visit (every 2 months throughout the study).
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.
replacement therapy and will last one year (12 months), with a final follow-up visit 6 months
after meal replacement therapy ends.
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). Resting metabolic rate will be measured
and caloric allotment recalculated at each study visit (every 2 months throughout the study).
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.
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
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