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Teens with obesity: could a 12-week exercise and diet program improve your health?

NCT ID NCT06848478

Disease control Sponsor: Arkansas Children's Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study looks at how exercise and eating more fruits and vegetables affect the heart and metabolic health of 120 teens aged 13–17 with obesity. Participants will be split into four groups: standard care, exercise only, diet only, or both exercise and diet. Over 12 weeks, researchers will measure changes in blood fats, blood sugar, blood pressure, body fat, and fitness to see which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
exercise and dietary enrichment with fruits and vegetables
What this could lead to
If it works, this could show that combining exercise with a fruit- and vegetable-rich diet improves heart and metabolic health in teens with obesity.
What could go wrong
This is a small, early-stage behavioral study (120 teens) with no blinding, so results may be influenced by participant motivation or other factors. It tests lifestyle changes, not a drug, so benefits may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

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

13 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Male or female aged 13 to 17 years. * Newly enrolled in a weight management program. * Excessive weight: Class I obesity I (≥95% percentile to \< 120% of the 95th percentile), class II Obesity (≥120 to \<140% of the 95th percentile, or BMI ≥35 to \< 40 g/m2). * Less than 60 min/day of moderate to vigorous physical activity. * Fruit intake ≤ 1.5 cup equivalent per day. * Vegetable intake ≤ 1.5 cup equivalent per day. * Medical release. Exclusion Criteria: * Type 2 diabetes mellitus. * Asthma that requires daily use of inhalers to keep symptoms under control. * Asthma that requires the use of rescue inhalers (e.g., albuterol) \>2 days per week * Exercise-induced asthma. * Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS). * Epilepsy. * Cancer. * Chronic kidney disease. * Hormonal disease (e.g., hypothyroidism and growth hormone deficiency). * Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis). * Bleeding disorders (e.g., hemophilia). * Chronic infections (e.g., HIV, hepatitis B, hepatitis C). * Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest. * Pregnancy. * Dislike of \> 1 study product assessed at the initial visit. * Parent/child refusal to have blood drawn. * Refusal to authorize study investigators to access data from the clinical records.

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Conditions

The condition(s) this trial relates to.

Motor Activity Obesity obesity disorder

As listed by the trial registrant

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

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Children's Hospital Research Institute

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Arkansas Children's Nutrition Center

    RECRUITING

    Little Rock, Arkansas, 72202, United States

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