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Weight Loss With Meal-Replacement Therapy in Teens

Primary Purpose

Obesity, Severe, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal-replacement Therapy
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Severe focused on measuring Weight loss, Cardiometabolic, Meal-replacement therapy

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts 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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Meal-Replacements

Meal-Replacements Plus

Arm 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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Fatness (%)
Change in BF% (from baseline to 1-year)
Carotid- and radial artery augmentation index
Change in measure of arterial stiffness (from baseline to 1-year)
Carotid-radial pulse wave velocity (m/s)
Change in measure of arterial stiffness (from baseline to 1-year)
Impact of Weight-related on Quality of Life
Change in Weight-related QOL (from baseline to 1-year)
Lipids (HDL-c, LDL-c, TC, TG)
Change in lipids (from baseline to 1-year)
Blood Pressure
Change in blood pressure (from baseline to 1-year)

Full Information

First Posted
April 25, 2017
Last Updated
July 31, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03137433
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Severe, Pediatric Obesity
Keywords
Weight loss, Cardiometabolic, Meal-replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meal-Replacements
Arm Type
Experimental
Arm 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).
Arm Title
Meal-Replacements Plus
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal-replacement Therapy
Intervention Description
We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
Primary Outcome Measure Information:
Title
Weight loss (from baseline to 1-year)
Description
% change in BMI (kg/m2)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Body Fatness (%)
Description
Change in BF% (from baseline to 1-year)
Time Frame
52 Weeks
Title
Carotid- and radial artery augmentation index
Description
Change in measure of arterial stiffness (from baseline to 1-year)
Time Frame
52 weeks
Title
Carotid-radial pulse wave velocity (m/s)
Description
Change in measure of arterial stiffness (from baseline to 1-year)
Time Frame
52 weeks
Title
Impact of Weight-related on Quality of Life
Description
Change in Weight-related QOL (from baseline to 1-year)
Time Frame
52 weeks
Title
Lipids (HDL-c, LDL-c, TC, TG)
Description
Change in lipids (from baseline to 1-year)
Time Frame
52 weeks
Title
Blood Pressure
Description
Change in blood pressure (from baseline to 1-year)
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Weight Loss With Meal-Replacement Therapy in Teens

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