Weight Loss With Meal-Replacement Therapy in Teens

Pediatric Obesity Clinical Trial

Official title:

Enhancing Weight Loss With Meal-Replacement Therapy in Teens With Severe Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137433
• Other study ID #: PEDS-2017-25609
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: April 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Obesity, Severe
• Pediatric Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Meal-replacement Therapy
We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index (From Baseline to 1-year)	Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)	52 weeks
Secondary	Total Fat Mass (kg)	Change in fat mass from randomization to week 52	52 Weeks
Secondary	Carotid-radial Pulse Wave Velocity (m/s)	Change in measure of arterial stiffness (from baseline to 1-year)	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.	52 weeks
Secondary	Systolic Blood Pressure	Change in systolic blood pressure (from baseline to 1-year)	52 weeks
Secondary	Diastolic Blood Pressure	Change in diastolic blood pressure (from baseline to 1-year)	52 weeks
Secondary	Total Cholesterol	Total cholesterol (mg/dL)	52 Weeks
Secondary	HDL	High Density Lipoprotein (mg/dL)	52 Weeks
Secondary	LDL	Low Density Lipoprotein (mg/dL)	52 Weeks
Secondary	Triglyceride/HDL Cholesterol Ratio	Triglyceride/HDL cholesterol ratio (from baseline to 1-year)	52 weeks
Secondary	Total Glucose	Total Glucose (mg/dL)	52 Weeks
Secondary	Insulin	Insulin (mU/dL)	52 Weeks