Pediatric ObesityNCT04977947
Healthy Eating for My Infant (HEMI)
A study testing Healthy Eating for My Infant in people with Pediatric Obesity, run by University of Cincinnati at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Healthy Eating for My Infant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Infant has a major medical condition that requires specialized feeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45221
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program
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).
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Healthy Eating for My Infant
- Keywords
- Obesity prevention, Behavioral intervention, Health disparities, Trauma informed, Child nutrition, Responsive feeding, Infant
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating for My InfantBehavioural
Also called HEMI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start6 Jun 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be assigned to either the treatment or control condition (standard care).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Stough, University of Cincinnati
- Investigators
- Cathleen Stough, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977947
- Sponsor's protocol ID
- 2020-0698
- Status last verified
- Feb 2025
- First submitted
- 20 May 2021
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program
- ClinicalTrials.gov ID
- NCT04977947
- Acronym / sponsor ID
- 2020-0698
- Conditions
- Pediatric Obesity
- Keywords
- Obesity prevention, Behavioral intervention, Health disparities, Trauma informed, Child nutrition, Responsive feeding, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Infants will be assigned to either the treatment or control condition (standard care).
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating for My Infant Intervention | Experimental | Behavioral: Healthy Eating for My InfantParticipants 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. |
| Control | No intervention | –Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention. |
Who may qualify
- Ages
- 2 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Infant has a major medical condition that requires specialized feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Eating for My InfantAlso: HEMIThe 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. | Behavioural | Healthy Eating for My Infant Intervention |
Primary outcome
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.
3 secondary outcomes
Group Differences in Infant Diet Quality
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).
Group Differences in Infant Diet Diversity
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).
Treatment Acceptability
Time frame: The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathleen Stough, PhD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating for My Infant in people with Pediatric Obesity, run by University of Cincinnati at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.