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The Dose Trial: Behavioral Interventions for Childhood Obesity

This study, called The Dose Trial, is looking for 900 children aged 5-17 with obesity from Tennessee and Louisiana. It aims to find the best amount of time for a special program called Intensive Behavioral Lifestyle Modification (IBT) to help children manage their weight. All children will receive visits with their primary care provider, online learning modules, and counseling. You and your child would be randomly assigned to one of five groups, receiving either 13, 16, 19, 22, or 26 hours of IBT over six months. The main goal is to see how much your child's BMI (Body Mass Index, a measure of body fat) changes after one year. To join, your child must have a BMI at or above the 95th percentile, and you, as their parent/caregiver, must be at least 18, comfortable with English or Spanish, and able to attend sessions for 12 months.

Study design
This is an interventional study where 900 children will be randomly assigned to one of five groups, each receiving a different amount of Intensive Behavioral Lifestyle Modification (IBT).
What's involved
You and your child would attend scheduled sessions over 12 months, including visits with your child's primary care provider, online learning modules, and community resource counseling sessions.
Compensation
Not stated in the trial record.
Follow-up
Your child's BMI will be measured at the start of the study and again after one year.

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NCT06654323

The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity

Recruiting
NAAges 5–17InterventionalTreatment
Vanderbilt University Medical Center
~900 participants
Updated 2025-09-08 on ClinicalTrials.gov
What's tested:Intensive Behavioral Lifestyle Modification

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of the 95th BMI Percentile
Measured over 5 times over 12 months

Conditions

Childhood Obesity

Explore related trials

Childhood Obesity

Where it's being run

2 sites across 2 states
Louisiana1
Tennessee1

Study leadership

  • William Heerman, MD MPH · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
  • Amanda Staiano, PhD · PRINCIPAL_INVESTIGATOR · Pennington Biomedical Research Center

Who to contact

Filoteia Popescu
[email protected]
615-322-7080
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent of the 95th BMI Percentile5 times over 12 months

    The primary outcome is child body mass index (BMI) expressed as a percentage of the 95th percentile (%BMIp95) of the CDC growth curves.