Healthy Eating Program for Childhood Obesity

CS
Overseen ByCathy Stough, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new program called Healthy Eating for My Infant (HEMI) to help prevent obesity in infants from low-income families. The program aims to improve infant growth, diet, and parenting habits to reduce future obesity risks. Families in the trial will either receive the HEMI program or continue with their usual home visiting services. The trial seeks families with a single infant around two months old, where the mother speaks English or Spanish. As an unphased trial, it offers families the chance to contribute to innovative research that could shape future health programs for infants.

What prior data suggests that the Healthy Eating for My Infant (HEMI) program is safe for infants?

Research shows that the "Healthy Eating for My Infant" (HEMI) program aims to prevent obesity in infants, particularly those from low-income families. Studies have examined how well infants and families accept this program and its potential benefits for nutrition and growth.

The HEMI program focuses on changing eating habits rather than using medications or physical treatments, ensuring safety. No reports of physical side effects have emerged from the program itself. Instead, it guides families toward healthier eating practices, which generally poses no direct risk to infants.

By improving diet and feeding practices, the program is easy for participants to follow. Since it doesn't involve drugs or invasive methods, families can safely try it.12345

Why are researchers excited about this trial?

Researchers are excited about the Healthy Eating for My Infant (HEMI) program because it offers a fresh approach to tackling childhood obesity by focusing on early dietary habits. Unlike current treatments that often address obesity after it has developed, HEMI aims to prevent it by educating parents on healthy feeding practices from infancy. This proactive strategy has the potential to create lasting healthy eating behaviors, reducing obesity risks from the start.

What evidence suggests that the Healthy Eating for My Infant (HEMI) program is effective for preventing childhood obesity?

Research shows that changing a child's diet can lower their body mass index (BMI) more effectively than standard healthcare. In a study on preventing childhood obesity, children experienced a noticeable drop in BMI scores over two years. These changes also led to healthier eating and lifestyle habits for both children and their parents. Participants in the intervention arm of this trial will receive the Healthy Eating for My Infant (HEMI) program, which aims to address obesity risk factors in infants from low-income families. Although specific data on HEMI's effectiveness is limited, similar programs have shown promise in helping young children grow healthily and reducing their risk of obesity.16789

Are You a Good Fit for This Trial?

This trial is for infants from low-income families at risk of obesity. It aims to help these families by considering their unique challenges, like maternal mental health and food insecurity. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Child is a singleton
I am fluent in either English or Spanish.
My child is between 2 to 3 months old.
See 1 more

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Healthy Eating for My Infant Intervention (HEMI) via home visiting

11 months
Home visits during child age 3-14 months

Post-treatment

Assessment of participant retention, treatment session completion, and treatment acceptability

Immediately after intervention
Post-treatment study visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of BMI, diet variety, diet quality, and food security

6 months
6-month follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

  • Healthy Eating for My Infant (HEMI)

Trial Overview

The 'Healthy Eating for My Infant' (HEMI) program is being tested. HEMI is delivered through home visits and focuses on improving infant growth patterns, diet quality, and parenting related to feeding practices to reduce future obesity risks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials
442
Recruited
639,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials
844
Recruited
6,566,000+

Every Child Succeeds

Collaborator

Trials
2
Recruited
310+

Citations

NCT04977947 | Healthy Eating for My Infant (HEMI)

Infants from underserved and minority backgrounds experience disparate rates of poor nutritional outcomes and subsequent health disparities related to obesity.

Study Details | NCT07284108 | Healthy Eating for My Infant ...

The current study will examine the feasibility and acceptability of HEMI delivered via home visiting, as well as preliminary efficacy for ...

Effectiveness of dietary interventions on weight outcomes ...

The results revealed that children who received dietary interventions had greater reduction in BMI when compared with usual healthcare (WMD: –0.12; 95% CI: – ...

Outcomes of a 24-month childhood obesity prevention ...

The primary outcome was change in child body mass index (BMI) z-score at 24 months. Secondary outcomes included number of positive child and parent changes in ...

The Cost-Effectiveness of Interventions for Reducing ...

2 The Cost-Effectiveness of Interventions for Reducing Obesity among Young Children through Healthy Eating,. Physical Activity, and Screen Time. The Evidence.

Reducing Health Disparities Through an Adaptive Healthy ...

HEMI targets healthy eating among infants who are at risk for health disparities and obesity starting at 3 months of age. HEMI will be delivered ...

Interventions for Childhood Obesity in the First 1000 Days

This study systematically reviews existing and ongoing interventions during this period, identifies gaps in current research, and discusses conceptual ...

A collaborative approach to developing sustainable behaviour ...

This study explores the development of the Choosing Healthy Eating for Infant Health (CHErIsH) childhood obesity prevention intervention and ...

Study Details | NCT07284108 | Healthy Eating for My Infant ...

Our team developed Healthy Eating for My Infant (HEMI) to address the specific obesity risk factors, barriers to health behaviors, and needs ...