A Novel Obesity Prevention Program for High-Risk Infants in Pediatric Primary Care: The THRIVE Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Conditional Weight Gain
- Status
- Recruiting
- Last Updated
- last year
Overview
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:
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- 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?
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- 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.
Investigators
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
Outcomes
Primary Outcomes
Conditional Weight Gain
Time Frame: At infant age 9-months (post-treatment)
Conditional Weight Gain scores will be calculated using length and weight of the infants. Length and weight will be measured in triplicate by masked research-reliable trained assessors and with standardized anthropometric procedures and averaged at each time point. Infants will be weighed unclothed, in a dry diaper using a Scale-Tronix 4802D Infant scale that is calibrated every day. Infant length will be measured using a Pediatric Stadiometer by O'Leary (PED LB35-07-X). Conditional weight gain is calculated as standardized residuals from the linear regression of anthropometric data (e.g., weight and length) on birthweight, with age and sex entered as covariates. Scores closer to 0 are ideal, with scores higher than 0 indicating more rapid weight gain and scores below 1 indicating slower weight gain. Primary outcomes will include conditional weight gain scores at the 9-month post-treatment time point.
Secondary Outcomes
- The Philadelphia Urban Adverse Childhood Experiences (ACES)(At infant age 1 month (baseline))
- Conditional Weight Gain(At infant age 12 months (follow-up))
- Maternal Self Efficacy(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- The Baby Eating Behavior Questionnaire(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- Edinburgh Postnatal Depression Scale (EPDS)(At infant age 1 month (baseline))
- The Food Frequency Questionnaire(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- Baby Day Diary(During active treatment at infant age: 2 months, 4 months, and 6 months)
- Baby Basic Needs Questionnaire(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- The Baby Care Questionnaire(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- The Infant Feeding Style Questionnaire(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- Infant Behavior Questionnaire - Revised - Very Short Form(At Infant Age: 9 months (post-treatment))
- Brief Infant Sleep Questionnaire - Revised(At infant age 1 month (baseline), 9 months (post-treatment), and 12 months (follow-up))
- Meals in our Household Questionnaire(At infant age 12 months (follow-up))
- Movement Behavior Questionnaire(At infant age 1 month (baseline, at infant age 9 months (post-treatment), at infant age 12 months (follow-up))