Weight Loss With Meal-Replacement Therapy in Teens

University of Minnesota (UMN)

Status: Completed

Conditions: Obesity, Severe; Pediatric Obesity

Treatments: Dietary Supplement: Meal-replacement Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03137433

PEDS-2017-25609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Meal-Replacements

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Meal-replacement Therapy

Meal-Replacements Plus

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Meal-replacement Therapy