Weight Loss With Meal-Replacement Therapy in Teens

Sponsor

University of Minnesota (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03137433

Collaborator

(none)

126

Enrollment

Location

Arms

63.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Severe Pediatric Obesity	Dietary Supplement: Meal-replacement Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Dietary Supplement: Meal-replacement Therapy We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Experimental: 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 will be provided additional information to go along with meal-replacements.	Dietary Supplement: Meal-replacement Therapy We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.

Arm

Intervention/Treatment

Experimental: Meal-Replacements

Dietary Supplement: Meal-replacement Therapy

We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.

Experimental: 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 will be provided additional information to go along with meal-replacements.

Dietary Supplement: Meal-replacement Therapy

We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.

Outcome Measures

Primary Outcome Measures

Weight loss (from baseline to 1-year) [52 weeks]
% change in BMI (kg/m2)

Secondary Outcome Measures

Body Fatness (%) [52 Weeks]
Change in BF% (from baseline to 1-year)
Carotid- and radial artery augmentation index [52 weeks]
Change in measure of arterial stiffness (from baseline to 1-year)
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]
Change in Weight-related QOL (from baseline to 1-year)
Lipids (HDL-c, LDL-c, TC, TG) [52 weeks]
Change in lipids (from baseline to 1-year)
Blood Pressure [52 weeks]
Change in blood pressure (from baseline to 1-year)

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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