Clinical trial NCT03137433: Weight Loss With Meal-Replacement Therapy in Teens
Official title: Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Severe
Pediatric Obesity
Keywords: Weight loss
Cardiometabolic
Meal-replacement therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 126
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index (From Baseline to 1-year)
timeFrame: 52 weeks
Secondary outcomes:
measure: Total Fat Mass (kg)
timeFrame: 52 Weeks
measure: Carotid-radial Pulse Wave Velocity (m/s)
timeFrame: 52 weeks
measure: Impact of Weight-related on Quality of Life
timeFrame: 52 weeks
measure: Systolic Blood Pressure
timeFrame: 52 weeks
measure: Diastolic Blood Pressure
timeFrame: 52 weeks
measure: Total Cholesterol
timeFrame: 52 Weeks
measure: HDL
timeFrame: 52 Weeks
measure: LDL
timeFrame: 52 Weeks
measure: Triglyceride/HDL Cholesterol Ratio
timeFrame: 52 weeks
measure: Total Glucose
timeFrame: 52 Weeks
measure: Insulin
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Aaron Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: