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

NCT ID: NCT07284108

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity & Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants randomized into this arm will receive the Healthy Eating for My Infant Intervention (HEMI).

Group Type EXPERIMENTAL

Healthy Eating for My Infant (HEMI)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

21 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Every Child Succeeds

UNKNOWN

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Cathy Stough

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Cathy Stough, PhD

Role: CONTACT

15135565589

Facility Contacts

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Cathy Stough, PhD

Role: primary

513-556-5589

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01DK142998-01

Identifier Type: NIH

Identifier Source: org_study_id

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