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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT07284108
Status
Enrolling By Invitation

Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
2 Months - 21 Months
Healthy Volunteers
Accepted

Interventions

  • Healthy Eating for My Infant (HEMI) — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control
    Participants randomized into this arm will not receive the study intervention. They will continue to receive standard home visiting services through Every Child Succeeds.
  • Experimental: Intervention
    Participants randomized into this arm will receive the Healthy Eating for My Infant Intervention (HEMI).

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45220-

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By research site
University of Cincinnati· Cincinnati, OH

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