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

NCT06654323 | Recruiting DMC

• 2 other identifiers: 241527BPS-2023C1-31064
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent of the 95th BMI Percentile

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

  5 times over 12 months

Secondary Outcomes (4)

• Child Diet

  12 months

• Child physical activity

  12 months

• Child Media Use

  12 months

• Child Sleep

  12 months

Study Arms (5)

26-hour intensive behavioral lifestyle intervention

EXPERIMENTAL

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).

Behavioral: Intensive Behavioral Lifestyle Modification

22-hour intensive behavioral lifestyle intervention

ACTIVE COMPARATOR

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).

Behavioral: Intensive Behavioral Lifestyle Modification

19-hour intensive behavioral lifestyle intervention

ACTIVE COMPARATOR

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).

Behavioral: Intensive Behavioral Lifestyle Modification

16-hour intensive behavioral lifestyle intervention

ACTIVE COMPARATOR

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).

Behavioral: Intensive Behavioral Lifestyle Modification

13-hour intensive behavioral lifestyle intervention

ACTIVE COMPARATOR

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).

Behavioral: Intensive Behavioral Lifestyle Modification

Interventions

Intensive Behavioral Lifestyle Modification BEHAVIORAL

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).

13-hour intensive behavioral lifestyle intervention; 16-hour intensive behavioral lifestyle intervention; 19-hour intensive behavioral lifestyle intervention; 22-hour intensive behavioral lifestyle intervention; 26-hour intensive behavioral lifestyle intervention

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Pennington Biomedical Research Center: collaborator

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Heerman, MD MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Amanda Staiano, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filoteia Popescu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 23, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)