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Mindfulness may curb diabetes risk in depressed teens

NCT ID NCT04992299

Disease control Sponsor: Colorado State University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tested whether a 6-week mindfulness program could help teens at risk for type 2 diabetes by reducing depression and insulin resistance. 120 teens aged 12-17 with overweight, a family history of diabetes, and elevated depression symptoms took part. They were randomly assigned to mindfulness, cognitive behavioral therapy, or health education, and followed for one year. The goal was to see if the programs could be delivered consistently across multiple sites and were acceptable to teens.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

May 2022

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adolescent: Age 12-17 years * At-risk for T2D: Overweight/obesity: BMI ≥85 percentile for age and sex Family history of T2D: ≥1 relative with T2D, prediabetes, or gestational diabetes in first- or second- degree relative, referring to a biological parent, sibling, aunt, uncle, or grandparent * Elevated depression symptoms: Center for Epidemiological Studies - Depression Scale (CES-D) total score \>20 * Good general health: Medical history/physical examination * Parent/guardian: Parent/guardian of qualifying participant Exclusion Criteria: * Major medical problem: including T2D, assessed at baseline/screening as fasting glucose ≥126 mg/dL or 2-hour glucose ≥200 mg/dL, or any other significant medical condition reported during the medical history/physical examination * Major psychiatric problem: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric diagnosis, including anorexia nervosa, bipolar disorder, bulimia nervosa, conduct disorder, major depressive disorder (MDD), obsessive compulsive disorder, panic disorder, posttraumatic stress disorder, psychosis, and substance/tobacco/alcohol use disorder * Regular medication use affecting mood, insulin, and/or weight: anti-anxiety medications, anti-depressants, anti-psychotics, insulin sensitizers, mood stabilizers, stimulants, and weight loss drugs * Active suicidal ideation or behavior * Regular psychotherapy or structured weight loss treatment * Pregnancy: as reported by adolescent participants (females)

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder Insulin Resistance Obesity obesity disorder prediabetes syndrome type 2 diabetes mellitus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent development Depression Insulin resistance Obesity Type 2 diabetes

Contacts and locations

Locations

  • Children's National Health System

    Washington D.C., District of Columbia, 20010, United States

  • Colorado State University

    Fort Collins, Colorado, 80523, United States

  • Uniformed Services University

    Bethesda, Maryland, 20814, United States

  • University of Colorado Denver/Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.