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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Time periods mentioned: 6 months, 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months."
  • "Participants in all arms will receive the same number of visits with their child's primary care provider (4 visits, 1 hour total), on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), and community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total)."
  • "The primary outcome is child body mass index (BMI) expressed as a percentage of the 95th percentile (%BMIp95) of the CDC growth curves, over 12 months, measured approximately 5 times."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how different amounts of intensive behavioral treatment (IBT) help children with obesity. IBT helps families make changes to daily habits. The study is for children ages 5–17 in Tennessee and Louisiana and their caregivers.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The child's BMI, a measure based on height and weight, is at or above the 95th percentile for their age and sex on CDC growth charts.
  • The parent or caregiver is at least 18 years old.
  • The family is comfortable speaking and reading English or Spanish.
  • The child gets care at a clinic taking part in the study.
  • The child and caregiver can give written or spoken agreement to join.
  • The family can attend sessions during the 12-month study and is willing to change daily habits and lifestyle.
  • The family can use the internet for online study activities.
  • The family completes starting measurements, including the child's height and weight, and at least 90% of starting survey questions within 14 days of the first visit.

Who can't join

  • The child's doctor or study leader thinks the study is not medically suitable, such as because of problems with development, eating, movement, thinking, or mental health.
  • The child is taking weight management medicine when joining.
  • The child plans to have weight loss surgery during the 12-month study.
  • The family plans to move during the 12-month study and will no longer get care at a participating clinic.

Simplified for readability. The official criteria below are what the study team uses.

Official 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/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.

Study sites (2)

LA

TN