Obesity & OverweightNCT07284108
Healthy Eating for My Infant: A Community- Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding
A study testing Healthy Eating for My Infant (HEMI) in people with Obesity & Overweight, run by University of Cincinnati at 1 site in United States.
Trial summary
Infants from low-income families are at increased risk for obesity, but obesity prevention programs tailored specifically to the needs of these infants are lacking. Our team developed Healthy Eating for My Infant (HEMI) to address the specific obesity risk factors, barriers to health behaviors, and needs articulated… Read more about this study
- Who is it for?
- Ages 2 to 21 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Healthy Eating for My Infant (HEMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age 2 months 0 days to 2 months 30 days at baseline.
- Child is a singleton.
- Mom's must be fluent in English or Spanish.
- Mom must be 18 years or older.
Who cannot join
- Child has major congenital abnormalities or medical conditions requiring specialized feeding.
- Family is currently enrolled in home grocery delivery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Acceptability, and Preliminary Phase II Efficacy Testing of a Community-Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding.
Infants from low-income families are at increased risk for obesity, but obesity prevention programs tailored specifically to the needs of these infants are lacking. Our team developed Healthy Eating for My Infant (HEMI) to address the specific obesity risk factors, barriers to health behaviors, and needs articulated by community members and low-income families (e.g., maternal mental health, realistic feeding options within the context of food insecurity). The current study will examine the feasibility and acceptability of HEMI delivered via home visiting, as well as preliminary efficacy for improving infant growth trajectories, diet, and parenting/feeding factors related to future obesity risk among infants from low-income families.
- Conditions
- Obesity & Overweight
- Being tested
- Healthy Eating for My Infant (HEMI)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating for My Infant (HEMI)Behavioural
Our team developed an obesity prevention program, Healthy Eating for My Infant (HEMI), to address the unique factors influencing obesity risk and health behaviors among low-income families and their infants and to be delivered in conjunction with an existing evidence-based home visiting program. HEMI targets healthy feeding with children 3-14 months old through twice monthly behavioral and educational sessions alongside sessions with a peer counselor with similar lived experience to mothers in the program. HEMI incorporates education and evidence-based behavioral techniques (e.g., problem solving, goal setting, behavioral rehearsal) to address topics such as infant nutrition, introduction of solid foods, responsive feeding, realistic healthy eating options, healthy eating on a budget, and recipes). All sessions are delivered in the families' homes. The intervention also includes free grocery delivery and supplemental funds for purchasing foods through grocery delivery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized into this arm will not receive the study intervention. They will continue to receive standard home visiting services through Every Child Succeeds. |
| Intervention | Experimental | Participants randomized into this arm will receive the Healthy Eating for My Infant Intervention (HEMI). Receives: Behavioral: Healthy Eating for My Infant (HEMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention
Participant retention is defined as the percentage of participants that complete each study visit. The percentage of participants completing the post-treatment measurement visit and the 6-month follow-up visit will be calculated, and separate percentages will be calculated for each arm of the study (i.e., control, intervention). This will be measured by tracking yes or no for whether each study visit is completed for each participant.
Measured: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit)
Treatment Session Completion
The percentage of treatment sessions completed within the designated completion windows will be monitored.
Measured: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program).
Treatment Acceptability
Families, peer counselors, and health behavior coaches delivering the program will evaluate program acceptability, utilizing the theoretical framework of acceptability. Families will complete an established questionnaire assessing components of the TFA: affective attitude and effectiveness, coherence and understanding, and perceived burden. The established questionnaire will also be modified to be completed by peer counselors and health behavior coaches to report their perception of acceptability of the program for families. Qualitative interviews will also be conducted with families, peer counselors, and health behavior coaches to identify any modifications to the HEMI program to improve acceptability.
Measured: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program), Immediately after the intervention (post-treatment study visit)
Body Mass Index
Anthropometrics will be measured in triplicate using a calibrated mobile digital SECA baby scale and portable infant length board. Infants will be weighed in a clean diaper without clothes to the nearest 1 gram. The length board has a stable headboard and a moveable foot piece and will be placed on a flat, hard surface. All length measurements will be performed by two team members, with one holding the infant's head straight and flush against the headboard, while the other places one hand across the knees to fully straighten and extend the legs so that heels are at a 90-degree angle against the foot piece and reads the measurement. If holding both legs is not possible, the measurement can be taken with only the right leg extended.
Measured: Between child ages 3-14 months (when the intervention condition is receiving the program), Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Diet Variety
Child diet will be assessed via three 24-hour dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the USDA automated multiple-pass method, a standardized interview approach demonstrated to improve accuracy of dietary intake data. Data from dietary recalls will be used to calculate diet variety using the minimum dietary diversity (MDD) approach.
Measured: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Diet Quality
Child diet will be assessed via three 24-hour dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the USDA automated multiple-pass method, a standardized interview approach demonstrated to improve accuracy of dietary intake data. The Nutrition Data Systems for Research (NDSR; Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess total daily energy and macronutrient intake as well as food group servings consumed. Data from dietary recalls will be used to calculate diet quality using the Healthy Eating Index (HEI-Toddlers-2020) for children under age 2 years.
Measured: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Food Security
Food security will be reported using the U.S. Household Food Security Survey Module: Short Form.
Measured: Baseline, immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start29 Jan 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Every Child Succeeds
- Responsible party
- Principal investigator, Cathy Stough, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284108
- Sponsor's protocol ID
- 1R01DK142998-01
- Status last verified
- Jun 2026
- First submitted
- 26 Nov 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In this proposed project, the raw participant-level data will be shared, along with derived metrics and transformations from initial raw data, with the exception of dietary intake data which will be available after processing by NDSR for nutrient and food servings information. Data will be made available in .csv format or other open file formats and will not require the use of specialized tools to be accessed or manipulated. In accordance with FAIR Principles for data, we will use open file formats (e.g., JPEG, MP4, CSV, TXT, PDF, HTML, etc.) and persistent unique identifiers (PIDs).
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Phase II Efficacy Testing of a Community-Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding.
- ClinicalTrials.gov ID
- NCT07284108
- Acronym / sponsor ID
- 1R01DK142998-01
- Conditions
- Obesity & Overweight
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Every Child Succeeds
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infants from low-income families are at increased risk for obesity, but obesity prevention programs tailored specifically to the needs of these infants are lacking. Our team developed Healthy Eating for My Infant (HEMI) to address the specific obesity risk factors, barriers to health behaviors, and needs articulated by community members and low-income families (e.g., maternal mental health, realistic feeding options within the context of food insecurity). The current study will examine the feasibility and acceptability of HEMI delivered via home visiting, as well as preliminary efficacy for improving infant growth trajectories, diet, and parenting/feeding factors related to future obesity risk among infants from low-income families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized into this arm will not receive the study intervention. They will continue to receive standard home visiting services through Every Child Succeeds. |
| Intervention | Experimental | Behavioral: Healthy Eating for My Infant (HEMI)Participants randomized into this arm will receive the Healthy Eating for My Infant Intervention (HEMI). |
Who may qualify
- Ages
- 2 to 21 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child age 2 months 0 days to 2 months 30 days at baseline.
- Child is a singleton.
- Mom's must be fluent in English or Spanish.
- Mom must be 18 years or older.
Key exclusion criteria (2 listed)
- Child has major congenital abnormalities or medical conditions requiring specialized feeding.
- Family is currently enrolled in home grocery delivery.
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 Infant (HEMI)Our team developed an obesity prevention program, Healthy Eating for My Infant (HEMI), to address the unique factors influencing obesity risk and health behaviors among low-income families and their infants and to be delivered in conjunction with an existing evidence-based home visiting program. HEMI targets healthy feeding with children 3-14 months old through twice monthly behavioral and educational sessions alongside sessions with a peer counselor with similar lived experience to mothers in the program. HEMI incorporates education and evidence-based behavioral techniques (e.g., problem solving, goal setting, behavioral rehearsal) to address topics such as infant nutrition, introduction of solid foods, responsive feeding, realistic healthy eating options, healthy eating on a budget, and recipes). All sessions are delivered in the families' homes. The intervention also includes free grocery delivery and supplemental funds for purchasing foods through grocery delivery. | Behavioural | Intervention |
Primary outcome
Participant Retention
Time frame: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit)
Participant retention is defined as the percentage of participants that complete each study visit. The percentage of participants completing the post-treatment measurement visit and the 6-month follow-up visit will be calculated, and separate percentages will be calculated for each arm of the study (i.e., control, intervention). This will be measured by tracking yes or no for whether each study visit is completed for each participant.
Treatment Session Completion
Time frame: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program).
The percentage of treatment sessions completed within the designated completion windows will be monitored.
Treatment Acceptability
Time frame: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program), Immediately after the intervention (post-treatment study visit)
Families, peer counselors, and health behavior coaches delivering the program will evaluate program acceptability, utilizing the theoretical framework of acceptability. Families will complete an established questionnaire assessing components of the TFA: affective attitude and effectiveness, coherence and understanding, and perceived burden. The established questionnaire will also be modified to be completed by peer counselors and health behavior coaches to report their perception of acceptability of the program for families. Qualitative interviews will also be conducted with families, peer counselors, and health behavior coaches to identify any modifications to the HEMI program to improve acceptability.
Body Mass Index
Time frame: Between child ages 3-14 months (when the intervention condition is receiving the program), Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Anthropometrics will be measured in triplicate using a calibrated mobile digital SECA baby scale and portable infant length board. Infants will be weighed in a clean diaper without clothes to the nearest 1 gram. The length board has a stable headboard and a moveable foot piece and will be placed on a flat, hard surface. All length measurements will be performed by two team members, with one holding the infant's head straight and flush against the headboard, while the other places one hand across the knees to fully straighten and extend the legs so that heels are at a 90-degree angle against the foot piece and reads the measurement. If holding both legs is not possible, the measurement can be taken with only the right leg extended.
Diet Variety
Time frame: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Child diet will be assessed via three 24-hour dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the USDA automated multiple-pass method, a standardized interview approach demonstrated to improve accuracy of dietary intake data. Data from dietary recalls will be used to calculate diet variety using the minimum dietary diversity (MDD) approach.
Diet Quality
Time frame: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Child diet will be assessed via three 24-hour dietary recall interviews conducted with mothers by phone. Trained interviewers, blinded to participant study condition, will employ the USDA automated multiple-pass method, a standardized interview approach demonstrated to improve accuracy of dietary intake data. The Nutrition Data Systems for Research (NDSR; Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and foods database will be used to assess total daily energy and macronutrient intake as well as food group servings consumed. Data from dietary recalls will be used to calculate diet quality using the Healthy Eating Index (HEI-Toddlers-2020) for children under age 2 years.
Food Security
Time frame: Baseline, immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit).
Food security will be reported using the U.S. Household Food Security Survey Module: Short Form.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. In this proposed project, the raw participant-level data will be shared, along with derived metrics and transformations from initial raw data, with the exception of dietary intake data which will be available after processing by NDSR for nutrient and food servings information. Data will be made available in .csv format or other open file formats and will not require the use of specialized tools to be accessed or manipulated. In accordance with FAIR Principles for data, we will use open file formats (e.g., JPEG, MP4, CSV, TXT, PDF, HTML, etc.) and persistent unique identifiers (PIDs).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (HEMI) in people with Obesity & Overweight, run by University of Cincinnati at 1 site 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Participant Retention (time frame: Immediately after the intervention (post-treatment study visit), 6 months after completion of the post-treatment study visit (6 month follow-up visit)). The study lists 7 primary outcomes in all. 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 11 Jun 2026.