Healthy Eating for My Infant (HEMI)

NCT04977947 | Completed Results

• 1 other identifier: 2020-0698
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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).

Conditions

Pediatric Obesity

Keywords

Obesity prevention; Behavioral intervention; Health disparities; Trauma informed; Child nutrition; Responsive feeding; Infant

Outcome Measures

Primary Outcomes (1)

• Group Differences in Infant BMI

  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.

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

Secondary Outcomes (3)

• 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 Arms (2)

Healthy Eating for My Infant Intervention

EXPERIMENTAL

Participants and their parents will participate in a 6 session intervention targeting healthy introduction of complementary foods, and responsive feeding and mealtime behaviors. Intervention sessions will occur when the infant is 3, 4, 5, 6, 7, and 8 months of age.

Behavioral: Healthy Eating for My Infant

Control

NO INTERVENTION

Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.

Interventions

Healthy Eating for My Infant BEHAVIORAL

The intervention targets problem solving to overcome barriers, behavioral rehearsal and practice of healthy behaviors, promoting readiness to change, goal setting, self-monitoring, and behavioral tracking. Two standard treatment modules will be provided to each family by a study interventionist focusing on infant nutritional requirements, responsive feeding, and mealtime behaviors. Two additional treatment modules will be selected to address the unique needs articulated by each family (e.g., food insecurity, eating healthy on a limited income, emotional eating, engaging other caregivers, maternal mental health). Modules will consider the influence of maternal trauma history and mental health on feeding and eating behavior. The intervention also includes two peer counselor-led sessions during which families can discuss implementation of recommendations and barriers to change with a member of their community who can problem solve and support change.

Also known as: HEMI

Healthy Eating for My Infant Intervention

Eligibility Criteria

• Age: 2 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infant has a major medical condition that requires specialized feeding

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

This study used a small sample size, limiting power for identifying efficacy. Given the small sample, we were unable to conduct an analysis to identify the benefit of each component. Given families were allowed to select modules, each family received a different combination of modules. Different modules may have had varied impact on study outcomes; our study was unable to explore the impact of individual modules or variations of combinations of modules.

Results Point of Contact

• Title: Cathleen Stough, Ph.D.
• Organization: University of Cincinnati

odarcc@ucmail.uc.edu

513-556-5589

Study Officials

• Cathleen Stough, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Infants will be assigned to either the treatment or control condition (standard care).

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: July 27, 2021
• Study Start: June 6, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-02

Locations

US (2)