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Clinical Trials/NCT04977947
NCT04977947
Completed
N/A

Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program

University of Cincinnati2 sites in 1 country30 target enrollmentJune 6, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
University of Cincinnati
Enrollment
30
Locations
2
Primary Endpoint
Group Differences in Infant BMI
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2022
End Date
November 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cathy Stough

Assistant Professor

University of Cincinnati

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

Outcomes

Primary Outcomes

Group Differences in Infant BMI

Time Frame: The measure of group differences in infant BMI will be completed at post-treatment (when the child is 9 months of age).

Families receiving the program will be compared to infants in control families who receive standard ECS content only to determine which group has a lower proportion of infants with Body Mass Index greater than or equal to the 85th percentile. Anthropometrics were measured in triplicate using a calibrated mobile digital SECA baby scale and portable infant length board. Infants were weighed in a clean diaper without clothes to the nearest 1 gram. All length measurements were performed by two team members. Infant BMI standardized for age and sex was calculated from the WHO 2005 growth standards to obtain BMI percentile. Percentiles under the 5th percentile are considered underweight, percentiles between 5th- 85th percentile are considered healthy weight, percentiles 85th- 95th percentile are considered overweight, and percentiles equal to or greater than the 95th percentile are considered obesity.

Secondary Outcomes

  • Group Differences in Infant Diet Quality(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).)
  • Group Differences in Infant Diet Diversity(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).)
  • Treatment Acceptability(The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).)

Study Sites (2)

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