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Completed

NCT Number: NCT03137433

Weight Loss With Meal-Replacement Therapy in Teens

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.

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Key information

Conditions

Obesity, Severe Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Weight Loss

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal-replacement Therapy

Dietary Supplement

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

Primary outcomes

  1. Body Mass Index (From Baseline to 1-year)

    Time frame: 52 weeks

    Percent change in body mass index (BMI) from baseline to 1-year (kg/m2)

Secondary outcomes

  1. Total Fat Mass (kg)

    Time frame: 52 Weeks

    Change in fat mass from randomization to week 52

  2. Carotid-radial Pulse Wave Velocity (m/s)

    Time frame: 52 weeks

    Change in measure of arterial stiffness (from baseline to 1-year)

  3. Impact of Weight-related on Quality of Life

    Time frame: 52 weeks

    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.

  4. Systolic Blood Pressure

    Time frame: 52 weeks

    Change in systolic blood pressure (from baseline to 1-year)

  5. Diastolic Blood Pressure

    Time frame: 52 weeks

    Change in diastolic blood pressure (from baseline to 1-year)

  6. Total Cholesterol

    Time frame: 52 Weeks

    Total cholesterol (mg/dL)

  7. HDL

    Time frame: 52 Weeks

    High Density Lipoprotein (mg/dL)

  8. LDL

    Time frame: 52 Weeks

    Low Density Lipoprotein (mg/dL)

  9. Triglyceride/HDL Cholesterol Ratio

    Time frame: 52 weeks

    Triglyceride/HDL cholesterol ratio (from baseline to 1-year)

  10. Total Glucose

    Time frame: 52 Weeks

    Total Glucose (mg/dL)

  11. Insulin

    Time frame: 52 Weeks

    Insulin (mU/dL)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
May 2, 2017
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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