Healthy Eating for My Infant: A Community- Informed Infant Obesity Prevention Program Addressing the Impact of Maternal Mental Health on Eating and Feeding

Primary outcomes

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.