Recruiting

Behavioral Interventions

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06654323

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Intensive Behavioral Lifestyle Modification

Study Details

Brief summary:

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

Conditions

Childhood Obesity

Study ID

NCT06654323

Start date

Feb 20, 2025

Status verified date

Aug, 2025

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 26-hour intensive behavioral lifestyle intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session).

active comparator: 22-hour intensive behavioral lifestyle intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 12 sessions (60 minutes per session).

active comparator: 19-hour intensive behavioral lifestyle intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professiona for 9 sessions (60 minutes per session).

active comparator: 16-hour intensive behavioral lifestyle intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 8 sessions (45 minutes per session).

active comparator: 13-hour intensive behavioral lifestyle intervention

Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 6 sessions (30 minutes per session).

Interventions

Intensive Behavioral Lifestyle Modification

Participants in all arms will receive 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 difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session), 12 sessions (60 minutes per session), 9 sessions (60 minutes per session), 8 sessions (45 minutes per session), or 6 sessions (30 minutes per session).

Primary outcome measure

  • Percent of the 95th BMI Percentile [ Time Frame: 5 times over 12 months ]

Central Contacts and Locations

Central contacts

Filoteia Popescu

615-322-7080filoteia.popescu@vumc.org

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Natalie Malek

225-763-2899Natalie.Malek@pbrc.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Filoteia Popescu

615-875-9083filoteia.popescu@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Sep 8, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-09-08.