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Can more coaching beat childhood obesity? 900 kids put to the test

NCT ID NCT06654323

Disease control Sponsor: Vanderbilt University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing different amounts of behavioral coaching for 900 children aged 5-17 with obesity. Kids and their caregivers are randomly assigned to receive between 13 and 26 hours of lifestyle coaching over six months, including nutrition advice, web-based learning, and community support. Researchers will measure changes in BMI, diet, exercise, sleep, and quality of life after one year to find the best dose of support.

What this could mean

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

Active substance
Intensive Behavioral Lifestyle Modification (IBT) including nutrition counseling, web-based learning, and community resource sessions
What this could lead to
If successful, this could identify the most effective amount of behavioral coaching to help children with obesity achieve a healthier weight and improve their diet and quality of life.
What could go wrong
This is a behavioral intervention study, not a drug trial, so results depend heavily on participant adherence. The study is also limited to two U.S. states, so findings may not apply everywhere.

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 900 people

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

Started

Feb 2025

Expected to finish

Aug 2028

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

5 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: * BMI≥95th percentile for age and sex based on standardized CDC growth curves. * parent/caregiver aged ≥ 18 years old * are comfortable speaking and reading English or Spanish; * are a patient of a participating clinical practice; * are able to provide written or verbal consent/assent; * are able to attend scheduled sessions in the 12-month study; * are willing to make behavioral and lifestyle changes; * are able to access the internet to participate in online intervention components; * complete baseline data collection, including child height and weight; and * complete at least 90% of baseline survey items no later than 14 days after the baseline visit. Exclusion Criteria: * families for whom the primary care provider (PCP) or site principal investigator (PI) thinks the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, disordered eating, mobility impairments, cognitive or mental difficulties); * participant child is taking weight management medications at the time of enrollment; * participant child plans to undergo bariatric surgery or another weight loss operation during the 12-month study; or * participant caregiver-child dyad has plans to move during the 12-month study and will no longer be a patient of a participating clinic.

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Conditions

The condition(s) this trial relates to.

obesity disorder Pediatric Obesity

As listed by the trial registrant

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

Childhood 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

  • Pennington Biomedical Research Center

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37212, United States

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