Healthy Eating for My Infant (HEMI) Program for Obesity Prevention
This study is testing a program called Healthy Eating for My Infant (HEMI) to help prevent obesity in infants from low-income families. Researchers developed HEMI to address specific challenges these families face, including maternal mental health and food insecurity. The program will be delivered through existing home visiting services. The study aims to see if HEMI is practical and acceptable to families, and if it can improve infant growth, diet, and parenting/feeding habits that affect future obesity risk. To join, your child must be between 2 and 2.5 months old, a single birth, and you must be 18 or older and fluent in English or Spanish. The study is looking to enroll 60 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific program. It plans to enroll 60 participants.
- What's involved
- The intervention will be delivered between your child's age of 3 months and 14 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed immediately after the intervention and again 6 months later.
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Healthy Eating for My Infant: A Community- Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Participant RetentionImmediately 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 CompletionBetween 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 AcceptabilityBetween 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 IndexBetween 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 VarietyImmediately 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 QualityImmediately 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 SecurityBaseline, 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.