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Enrolling by invitation NCT07284108

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

No phase Interventional Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Healthy Eating for My Infant (HEMI).
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 2 months — 21 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Behavioral 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 t

Primary outcome measures

  • 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)]
  • Treatment Session Completion [Time frame: Between child age 3 months-14 months (the time period during which the intervention condition is receiving the program).]
  • 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)]
  • 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).]
  • 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).]
  • 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).]
  • 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).]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Child has major congenital abnormalities or medical conditions requiring specialized feeding.
  • Family is currently enrolled in home grocery delivery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Cincinnati — Cincinnati

Identifiers

NCT: NCT07284108 · 1R01DK142998-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗