No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for children aged 5-17 with obesity in Tennessee and Louisiana. Participants will receive different amounts of support to help with weight management over a year, including help from healthcare providers.
Are You a Good Fit for This Trial?
You may be able to join if
I have a BMI at or above the 95th percentile for my age and sex.
I have a parent or caregiver who is at least 18 years old.
I can speak and read English or Spanish.
I am a patient at a participating clinic.
I can give consent or assent.
I can attend scheduled sessions for 12 months.
I am willing to make lifestyle changes.
I can access the internet for online activities.
You may not be able to join if
My doctor thinks the study is not suitable for me.
I am taking weight management medications.
I plan to have weight loss surgery during the study.
My caregiver and I plan to move during the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and…
The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and their caregivers receive 16, 19, or 22 hours of IBT.
Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months. At the start of the study and again after one year, the research team is measuring the children's body mass index, or BMI. BMI is a measure of a person's body fat based on their height and weight. The team is also looking at the children's:
* Diet
* Exercise
* Sleep
* Media use
* Quality of life
Trial Locations
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City
State
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Status
Eligibility Criteria
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/…
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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