Trial Outcomes & Findings for Healthy Eating for My Infant (HEMI) (NCT NCT04977947)

Last Updated: 2025-03-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

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

Results posted on

2025-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Control Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Healthy Eating for My Infant Intervention n=14 Participants 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.	Control n=13 Participants Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Group Differences in Infant BMI participants post BMI > 85th	5 Participants	2 Participants
Group Differences in Infant BMI participants post BMI < 85th	9 Participants	11 Participants

SECONDARY outcome

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).

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.

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.

Outcome measures

Outcome measures
Measure	Healthy Eating for My Infant Intervention n=14 Participants 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.	Control n=14 Participants Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Group Differences in Infant Diet Quality	47.57 score on a scale Standard Deviation 7.20	46.50 score on a scale Standard Deviation 7.70

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Healthy Eating for My Infant Intervention n=14 Participants 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.	Control n=14 Participants Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Group Differences in Infant Diet Diversity	4.24 food groups Standard Deviation 1.13	4.01 food groups Standard Deviation 1.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Eating for My Infant Intervention n=13 Participants 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.	Control Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Treatment Acceptability Overall Acceptability	94.29 units on a scale Standard Deviation 9.38	—
Treatment Acceptability Affective attitude and effectiveness	89.17 units on a scale Standard Deviation 8.72	—
Treatment Acceptability Coherence and understanding	88.10 units on a scale Standard Deviation 10.52	—
Treatment Acceptability Perceived burden	65.00 units on a scale Standard Deviation 18.29	—

Adverse Events

Healthy Eating for My Infant Intervention

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Control

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Healthy Eating for My Infant Intervention n=15 participants at risk 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.	Control n=15 participants at risk Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Respiratory, thoracic and mediastinal disorders RSV	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	13.3% 2/15 • Number of events 2 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Ear and labyrinth disorders Ear Infection	13.3% 2/15 • Number of events 2 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Flu/Virus	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Immune system disorders Swollen Nodes	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Immune system disorders Flu/Virus	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Surgical and medical procedures NJ/NG Tube Surgery	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 2 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Croup	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.

Other adverse events

Other adverse events
Measure	Healthy Eating for My Infant Intervention n=15 participants at risk 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.	Control n=15 participants at risk Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 3/15 • Number of events 4 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	13.3% 2/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Immune system disorders Allergic Reaction	6.7% 1/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	13.3% 2/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Skin and subcutaneous tissue disorders Eczema	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Eye disorders Eye Irritation	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Bronchitis	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Surgical and medical procedures Surgical Procedure	20.0% 3/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Injury, poisoning and procedural complications Injury	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 2 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Ear and labyrinth disorders Hearing Difficulties	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Gastrointestinal disorders Acid Reflux	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	6.7% 1/15 • Number of events 1 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Choking	40.0% 6/15 • Number of events 7 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	13.3% 2/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Ear and labyrinth disorders Ear Infection	20.0% 3/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	20.0% 3/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Immune system disorders Fever	26.7% 4/15 • Number of events 5 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	0.00% 0/15 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Respiratory, thoracic and mediastinal disorders Congestion	20.0% 3/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	13.3% 2/15 • Number of events 2 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.
Immune system disorders Viral Infections	20.0% 3/15 • Number of events 3 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.	26.7% 4/15 • Number of events 6 • Adverse event data was collected during the intervention period and at post-treatment assessment (6 months). Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities. Severe: An event that prevents normal everyday activities. AEs were collected at each intervention session (Session 1, Session 2, Session 4, Session 5) and at post treatment for both intervention and control families.

Additional Information

Cathleen Stough, Ph.D.

University of Cincinnati

Phone: 513-556-5589

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Healthy Eating for My Infant Intervention n=15 Participants 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.	Control n=15 Participants Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.	Total n=30 Participants Total of all reporting groups
Age, Continuous	71.67 days STANDARD_DEVIATION 9.42 • n=15 Participants	73.53 days STANDARD_DEVIATION 8.93 • n=15 Participants	72.60 days STANDARD_DEVIATION 9.07 • n=30 Participants
Sex: Female, Male Female	5 Participants n=15 Participants	6 Participants n=15 Participants	11 Participants n=30 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	9 Participants n=15 Participants	19 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=15 Participants	6 Participants n=15 Participants	12 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=15 Participants	9 Participants n=15 Participants	18 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Race (NIH/OMB) Asian	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Race (NIH/OMB) Black or African American	4 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	2 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	6 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Race (NIH/OMB) White	3 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	5 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	8 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Race (NIH/OMB) More than one race	2 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	2 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	4 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=9 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.	0 Participants n=18 Participants • Ethnicity and race identities overlapped for some participants (e.g., Hispanic and Black). Other participants reported their race and ethnicity as Hispanic.
Region of Enrollment United States	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants
Birthweight	118.33 oz STANDARD_DEVIATION 13.74 • n=15 Participants	111.53 oz STANDARD_DEVIATION 14.86 • n=15 Participants	114.93 oz STANDARD_DEVIATION 14.48 • n=30 Participants
Body Mass Index Percentile (calculated from WHO Growth Charts)	51.69 percentile STANDARD_DEVIATION 28.41 • n=15 Participants	53.85 percentile STANDARD_DEVIATION 28.95 • n=15 Participants	52.77 percentile STANDARD_DEVIATION 28.20 • n=30 Participants