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
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;
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.
Parallel
Intensive Behavioral Lifestyle Modification
BehavioralParticipants 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).
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.
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.
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.
Child Media Use
Cumulative Media Use Index, which is a summary score ranging from 0 to 14, where high numbers represent more media use.
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
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Vanderbilt University Medical Center
Lead sponsor
Pennington Biomedical Research Center
Collaborator
