Clinical trial NCT04977947: Healthy Eating for My Infant (HEMI)
Official title: Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Obesity prevention
Behavioral intervention
Health disparities
Trauma informed
Child nutrition
Responsive feeding
Infant
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants will be assigned to either the treatment or control condition (standard care).
Primary purpose: PREVENTION

Brief summary: Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking. The current study takes a community-engaged approach to development and delivery of an adaptively tailored obesity prevention program delivered via home visiting to target infant eating and feeding (Healthy Eating for My Infant; HEMI).

Detailed description: Poor dietary habits and obesity-risk begin early in infancy. Infants from underserved and minority backgrounds experience disparate rates of poor nutritional outcomes and subsequent health disparities related to obesity. Each infant and their family experiences a unique set of risk factors and barriers to healthy eating. However, obesity prevention programs that are culturally and contextually relevant for underserved families and adapted based on the needs of individual families are lacking. The current study will develop an obesity prevention program, Healthy Eating for My Infant (HEMI), using a community-engaged approach involving community members in development and delivery of the program. HEMI targets healthy infant feeding through six monthly sessions with infants 3-8 months old. The program will be delivered as a supplement to an already existing evidence-based home visiting program, Every Child Succeeds (ECS), serving families with primarily low income and ethnic/racial minority backgrounds.

Development of an adaptive and effective obesity prevention program meeting the needs of underserved infants is critical for addressing health disparities in infant eating and obesity.

Eligibility criteria: Inclusion Criteria:

* Infant enrolled in the Every Child Succeeds (ECS) program
* Infant age is \< 2 months at study recruitment
* Infant born at \> 37 weeks gestation
* Infant is a singleton
* Maternal age is \> 18 years (in order to consent for child to participate)
* Mother is fluent in English or Spanish

Exclusion Criteria:

* Infant has a major medical condition that requires specialized feeding

Primary outcomes:
measure: Group Differences in Infant BMI
timeFrame: The measure of group differences in infant BMI will be completed at post-treatment (when the child is 9 months of age).
Secondary outcomes:
measure: Group Differences in Infant Diet Quality
timeFrame: The measure of infant diet will be completed within 2 weeks of the baseline visit (when the child is 2 months of age) and again within 2 weeks of the post-treatment visit (when the child is 9 months of age).
measure: Group Differences in Infant Diet Diversity
timeFrame: The measure of infant diet will be completed within 2 weeks of the baseline visit (when the child is 2 months of age) and again within 2 weeks of the post-treatment visit (when the child is 9 months of age).
measure: Treatment Acceptability
timeFrame: The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Cathleen Stough, PhD
role: PRINCIPAL_INVESTIGATOR
References: