CompletedNot Applicable

Weight Loss With Meal-Replacement Therapy in Teens

United States126 participantsStarted 2018-01-02

Plain-language 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.

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body Mass Index (From Baseline to 1-year)

Timeframe: 52 weeks

Trial details

NCT IDNCT03137433

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

Results submitted2023-09-13

View on ClinicalTrials.gov More Obesity, Severe trials

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.