Weight Loss With Meal-Replacement Therapy in Teens

NCT ID: NCT03137433

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2023-04-30

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.

Conditions

Obesity, Severe; Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Meal-replacement Therapy

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

Meal-replacement Therapy

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Meal-replacement Therapy

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Gross AC, Freese RL, Bensignor MO, Bomberg EM, Dengel DR, Fox CK, Rudser KD, Ryder JR, Bramante CT, Raatz S, Lim F, Hur C, Kelly AS. Financial Incentives and Treatment Outcomes in Adolescents With Severe Obesity: A Randomized Clinical Trial. JAMA Pediatr. 2024 Aug 1;178(8):753-762. doi: 10.1001/jamapediatrics.2024.1701.

Reference Type: DERIVED

PMID: 38884967 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PEDS-2017-25609

Identifier Type: -

Identifier Source: org_study_id