Healthy Eating for My Infant (HEMI)

Not Applicable

Completed

Conditions: Pediatric Obesity

Interventions: Behavioral: Healthy Eating for My Infant

Registration Number: NCT04977947

Lead Sponsor: University of Cincinnati

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Eating for My Infant Intervention	Healthy Eating for My Infant	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.

Primary Outcome Measures

Name	Time	Method
Group Differences in Infant BMI	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 Outcome Measures

Name	Time	Method
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).	Diet will be assessed via three random dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the United States Department of Agriculture (USDA) automated multiple-pass method (AMPM), a standardized interview approach. Differences between the control and intervention group on diet quality (Healthy Eating Index; HEI) at post-treatment were calculated. Scores range from 0- 100 with higher scores representing greater diet quality. Footnote: Originally proposed study outcomes included examination of pre-post changes in diet by treatment group (e.g., food groups) but this analysis was not possible because at baseline infants were 2 months of age and not yet consuming any solid foods.
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).	Diet will be assessed via three random dietary recall interviews conducted with mothers by phone within 2 weeks of the baseline and post-treatment study visit dates. Trained interviewers, blinded to participant study condition, will employ the United States Department of Agriculture (USDA) automated multiple-pass method (AMPM), a standardized interview approach. Differences between the control and intervention group on diet diversity (Minimum Diet Diversity) at post-treatment were calculated. Adequate MDD is defined as consuming a food from 4 or more of seven food groups in any amount during the prior 24 hours (possible score range 0- 7). Footnote: Originally proposed study outcomes included examination of pre-post changes in diet by treatment group (e.g., food groups) but this analysis was not possible because at baseline infants were 2 months of age and not yet consuming any solid foods.
Treatment Acceptability	The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).	Family perception of program acceptability was reported using an established questionnaire assessing components of the theoretical framework of acceptability (TFA; Timm et al., 2022) with minor wording adaptations to better fit the HEMI program. The total measure included 3 subscale scores: Affective attitude and effectiveness, coherence and understanding, and perceived burden (Timm et al., 2022). A single overall acceptability question was also included. Scores were scaled to 100 with a score of 100 representing highest acceptability and 20 representing the lowest acceptability.

Trial Locations

Locations (2): University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States