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Healthy Eating for My Infant (HEMI)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04977947
Enrollment
30
Registered
2021-07-27
Start date
2022-06-06
Completion date
2023-11-01
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

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

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.

Interventions

BEHAVIORALHealthy Eating for My Infant

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.

Sponsors

University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
2 Months to 9 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Group Differences in Infant BMIThe 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

MeasureTime frameDescription
Group Differences in Infant Diet QualityThe 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 DiversityThe 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 AcceptabilityThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Healthy Eating for My Infant Intervention
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. Healthy Eating for My Infant: 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.
15
Control
Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
15
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up11

Baseline characteristics

CharacteristicHealthy Eating for My Infant InterventionControlTotal
Age, Continuous71.67 days
STANDARD_DEVIATION 9.42
73.53 days
STANDARD_DEVIATION 8.93
72.60 days
STANDARD_DEVIATION 9.07
Birthweight118.33 oz
STANDARD_DEVIATION 13.74
111.53 oz
STANDARD_DEVIATION 14.86
114.93 oz
STANDARD_DEVIATION 14.48
Body Mass Index Percentile (calculated from WHO Growth Charts)51.69 percentile
STANDARD_DEVIATION 28.41
53.85 percentile
STANDARD_DEVIATION 28.95
52.77 percentile
STANDARD_DEVIATION 28.2
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants6 Participants12 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants9 Participants18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants2 Participants6 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
3 Participants5 Participants8 Participants
Region of Enrollment
United States
15 participants15 participants30 participants
Sex: Female, Male
Female
5 Participants6 Participants11 Participants
Sex: Female, Male
Male
10 Participants9 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
14 / 159 / 15
serious
Total, serious adverse events
5 / 154 / 15

Outcome results

Primary

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.

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

Population: Was the participants post BMI \> 85th

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Healthy Eating for My Infant InterventionGroup Differences in Infant BMIparticipants post BMI > 85th5 Participants
Healthy Eating for My Infant InterventionGroup Differences in Infant BMIparticipants post BMI < 85th9 Participants
ControlGroup Differences in Infant BMIparticipants post BMI > 85th2 Participants
ControlGroup Differences in Infant BMIparticipants post BMI < 85th11 Participants
Secondary

Group Differences in Infant Diet Diversity

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.

Time frame: 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).

ArmMeasureValue (MEAN)Dispersion
Healthy Eating for My Infant InterventionGroup Differences in Infant Diet Diversity4.24 food groupsStandard Deviation 1.13
ControlGroup Differences in Infant Diet Diversity4.01 food groupsStandard Deviation 1.13
Secondary

Group Differences in Infant Diet Quality

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.

Time frame: 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).

Population: Data from dietary recalls at post-treatment (age nine months) will be used to calculate diet quality using the new Healthy Eating Index (HEI-Toddlers-2020) for children under two years of age.

ArmMeasureValue (MEAN)Dispersion
Healthy Eating for My Infant InterventionGroup Differences in Infant Diet Quality47.57 score on a scaleStandard Deviation 7.2
ControlGroup Differences in Infant Diet Quality46.50 score on a scaleStandard Deviation 7.7
Secondary

Treatment Acceptability

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.

Time frame: The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Eating for My Infant InterventionTreatment AcceptabilityOverall Acceptability94.29 units on a scaleStandard Deviation 9.38
Healthy Eating for My Infant InterventionTreatment AcceptabilityAffective attitude and effectiveness89.17 units on a scaleStandard Deviation 8.72
Healthy Eating for My Infant InterventionTreatment AcceptabilityCoherence and understanding88.10 units on a scaleStandard Deviation 10.52
Healthy Eating for My Infant InterventionTreatment AcceptabilityPerceived burden65.00 units on a scaleStandard Deviation 18.29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026