Clinical trial NCT06028113: A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
Official title: A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Obesity, Childhood
Weight Gain
Weight Gain Trajectory
Keywords: obesity prevention
infancy
integrated primary care
integrated behavioral health
responsive parenting
responsive feeding
sleep
soothing
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-09-08
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 2 pragmatic pilot and feasibility randomized controlled trial (RCT) of an obesity prevention intervention compared to usual pediatric care with 144 mother-infant dyads randomized n=72 per arm. Consistent with the definition of a pilot and feasibility clinical trial, our aims are to assess trial protocol feasibility based on THRIVE 2.0 and obtain effect sizes to inform the design of a Phase 3 multi-site efficacy trial.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test a responsive parenting obesity prevention program with infants and caregivers of color (e.g., non-White; Hispanic/Latinx) and/or who are economically marginalized (i.e., publicly insured), delivered via Integrated Behavioral Health (IBH) in pediatric primary care. The main questions it aims to answer are:

* 1) Is the obesity prevention intervention delivered via IBH in pediatric primary care feasible and acceptable to families of color and/or families who are economically marginalized?
* 2) Will it prevent rapid weight gain during infancy?

Participants will complete baseline (newborn), post-treatment (9 months), and follow-up assessments (12 months). Participants assigned to treatment will receive 4 prevention sessions as part of their typical well-child visit in pediatric primary care. Researchers hypothesize that infants in the obesity prevention intervention will have stable weight gain compared to infants in the control group (treatment as usual) will experience more rapid weight gain.

Detailed description: Unprecedented rates of obesity are occurring in childhood and disproportionally affect Black or African American youth, Hispanic or Latinx youth, and youth from economically marginalized backgrounds beginning as early as infancy. Obesity in infancy is not outgrown, tracks into adulthood, and places infants and children with obesity at a higher risk for significant medical comorbidities (e.g., cardiometabolic complications) in adulthood. The healthcare cost of obesity is \~$260 billion annually across the lifespan. Recent evidence suggests that infancy may be a critical period for the development of this high weight trajectory, as 10% of infants meet criteria for high weight-for-length; with the incidence being even higher among infants of color (16.3%), infants of Hispanic/Latinx ethnicity (12.1%), and economically marginalized infants (12.2%). Several modifiable predictors of obesity risk have been identified in infancy, including rapid weight gain in the first year, parental use of food to regulate infant distress, early introduction to solid foods, and insufficient infant total cumulative sleep. Given the greater risk for obesity, there is a critical need to identify and improve access to the most effective obesity prevention treatments for this population as a means of reducing the long-term healthcare burden.

This pilot RCT will compare a responsive parenting intervention to treatment as usual in pediatric primary care with 144 infants who are from communities of color (e.g., non-White; Hispanic or Latinx) and/or economically marginalized backgrounds (i.e., publicly insured). Families will receive four prevention sessions with the integrated behavioral health specialist at their routine primary care well-child visits during the first six months of life. The primary outcome measured is conditional weight gain (an indicator of rapid weight gain) at 9 months of age. The responsive parenting approach, delivered by an integrated behavioral health expert, has been culturally adapted for infants and caregivers who are economically marginalized and/or from communities of color through focus groups. The delivery of this intervention via integrated behavioral health in a pediatric primary care setting has the potential to have a significant public health impact in terms of preventing pediatric obesity later in life; and thus, improving health outcomes and reducing health disparities.

Eligibility criteria: Inclusion Criteria:

* born 2500 grams or greater
* delivery occurring between 37 and 42 weeks gestation
* English speaking
* infant receiving care provided at our pediatric primary care setting
* from a racial / ethnic minority group (i.e., non-white, or Hispanic or Latinx) and/or economically marginalized background (i.e., household income at or below 138% of federal poverty level; qualifying for Medicaid)

Exclusion Criteria:

* care in the Neonatal Intensive Care Unit (\>7 days)
* infant congenital anomaly or neonatal condition that affects feeding (e.g., cleft lip/palate, metabolic disease)
* infant exposure to illicit drugs in utero \[with the exception of tetrahydrocannabinol (THC)\]
* diminished or impaired caregiver cognitive functioning
* family intent to move from the area within 1 year

Primary outcomes:
measure: Conditional Weight Gain
timeFrame: At infant age 9-months (post-treatment)
Secondary outcomes:
measure: Conditional Weight Gain
timeFrame: At infant age 12 months (follow-up)
measure: The Baby Eating Behavior Questionnaire
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: The Infant Feeding Style Questionnaire
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: The Food Frequency Questionnaire
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: Baby Day Diary
timeFrame: During active treatment at infant age: 2 months, 4 months, and 6 months
measure: Baby Basic Needs Questionnaire
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: The Baby Care Questionnaire
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: Infant Behavior Questionnaire - Revised - Very Short Form
timeFrame: At Infant Age: 9 months (post-treatment)
measure: Brief Infant Sleep Questionnaire - Revised
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: Maternal Self Efficacy
timeFrame: At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up)
measure: The Philadelphia Urban Adverse Childhood Experiences (ACES)
timeFrame: At infant age 1 month (baseline)
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: At infant age 1 month (baseline)
measure: Movement Behavior Questionnaire
timeFrame: At infant age 1 month (baseline, at infant age 9 months (post-treatment), at infant age 12 months (follow-up)
measure: Meals in our Household Questionnaire
timeFrame: At infant age 12 months (follow-up)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Hopple Street Neighborhood Health Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Tiffany Rybak, PhD
role: PRINCIPAL_INVESTIGATOR
References: