RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-17
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06654323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * BMI≥95th percentile for age and sex based on standardized CDC growth curves.
  2. * parent/caregiver aged ≥ 18 years old
  3. * are comfortable speaking and reading English or Spanish;
  4. * are a patient of a participating clinical practice;
  5. * are able to provide written or verbal consent/assent;
  6. * are able to attend scheduled sessions in the 12-month study;
  7. * are willing to make behavioral and lifestyle changes;
  8. * are able to access the internet to participate in online intervention components;
  9. * complete baseline data collection, including child height and weight; and
  10. * complete at least 90% of baseline survey items no later than 14 days after the baseline visit.
  1. * 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);
  2. * participant child is taking weight management medications at the time of enrollment;
  3. * participant child plans to undergo bariatric surgery or another weight loss operation during the 12-month study; or
  4. * participant caregiver-child dyad has plans to move during the 12-month study and will no longer be a patient of a participating clinic.

Contacts and Locations

Study Contact

Filoteia Popescu
CONTACT
615-322-7080
filoteia.popescu@vumc.org

Principal Investigator

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

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-17
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2025-02-17
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • Behavioral Intervention
  • Rural and Urban Populations
  • Racial and Ethnic Minority Populations
  • Nutrition Counseling
  • Community Resource Counseling

Additional Relevant MeSH Terms

  • Childhood Obesity