Childhood ObesityNCT06654323
The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity
A study testing Intensive Behavioral Lifestyle Modification in people with Childhood Obesity, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Intensive Behavioral Lifestyle Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2025to 1 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Natalie Malek, 225-763-2899, Natalie.Malek@pbrc.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Filoteia Popescu, 615-875-9083, filoteia.popescu@vumc.org
About this study
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
Read the detailed description
The Dose study aims to evaluate the optimal number of contact hours (i.e., dose) of intensive behavioral lifestyle interventions for childhood obesity. Current recommendations by the American Academy of Pediatrics (AAP) and the United States Preventive Services Task Force (USPSTF) suggest that intensive behavioral lifestyle interventions should have at least 26 hours of contact time. This is a difficult standard to achieve, as it requires significant resources from healthcare systems and time from families. This study\'s purpose is to test whether 26 hours is needed to achieve clinically meaningful reductions in child weight among children with obesity.
The investigators will conduct a randomized clinical trial (RCT) where children are randomized to one of five treatment intensities: 26 hours, 22 hours, 19 hours, 16 hours, or 13 hours. The study will use a non-inferiority design: can equal effectiveness be achieved comparing the 26-hour standard to reduced intensities?
900 children with obesity ages 5-17 years old will be randomized, with a focus on rural and minority communities in Tennessee (TN) and Louisiana (LA). The study will engage approximately 15 clinics in TN and 15 in LA.
The intervention will be integrated into local pediatric primary care practices. 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 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).
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. Our primary hypothesis is that 13-hours will be non-inferior to 26-hours. The analysis also includes multiple, pre-specified sub-group analyses, as there may be important subgroups who require more than 13 hours (e.g., children with a very high starting BMI). Secondary outcomes include changes in child quality of life and health behaviors. The analysis will assess reach, feasibility, and accessibility of this approach for both participants and pediatric healthcare providers, guided by the RE-AIM framework.
- Conditions
- Childhood Obesity
- Being tested
- Intensive Behavioral Lifestyle Modification
- Keywords
- Behavioral Intervention, Rural and Urban Populations, Racial and Ethnic Minority Populations, Nutrition Counseling, Community Resource Counseling
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Behavioral Lifestyle ModificationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Behavioral: Intensive Behavioral Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 times over 12 months
Secondary outcomes (4)
Child Diet
Diet Recall, using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. A variety of dietary measures will be abstracted from this dietary recall including the total number of calories consumed daily and the Healthy Eating Index (HEI) which has a range of 0-100, where higher numbers represent a healthier diet.
Measured: 12 months
Child physical activity
Physical Activity Questionnaire for Children or Adolescents, which provides a summary physical activity score derived from nine items, each scored on a 5-point scale. High scores represent more physical activity.
Measured: 12 months
Child Media Use
Cumulative Media Use Index, which is a summary score ranging from 0 to 14, where high numbers represent more media use.
Measured: 12 months
Child Sleep
Short Form Children's Sleep Habits Questionnaire, scored with a range of 23 to 39 where a higher score is indicative of more disturbed sleep
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start20 Feb 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Principal investigator, Bill Heerman, Vanderbilt University Medical Center
- Investigators
- William Heerman, MD MPH, Principal investigator, Vanderbilt University Medical CenterAmanda Staiano, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654323
- Sponsor's protocol ID
- 241527
- Other IDs
- BPS-2023C1-31064
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No