Healthy Eating for My Infant (HEMI)
Primary Purpose
Pediatric Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Eating for My Infant
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Obesity prevention, Behavioral intervention, Health disparities, Trauma informed, Child nutrition, Responsive feeding, Infant
Eligibility Criteria
Inclusion Criteria:
- Families enrolled in the Every Child Succeeds (ECS) program
- Infant age is < 2 months at study recruitment
- Infant born at > 37 weeks gestation
- Maternal age is > 18 years
- Mother is a singleton
- Mother is fluent in English or Spanish
Exclusion Criteria:
- Infant has a major medical condition that requires specialized feeding
Sites / Locations
- University of CincinnatiRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Healthy Eating for My Infant Intervention
Control
Arm Description
Participants and their parents will participate in a 6 session intervention targeting healthy introduction of complementary foods, and responsive feeding and mealtime behaviors. Intervention sessions will occur when the infant is 3, 4, 5, 6, 7, and 8 months of age.
Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Outcomes
Primary Outcome Measures
Group Differences in Infant BMI
Families receiving the program will be compared to infants in control families who receive standard ECS content only to determine which group has a lower proportion of infants with BMI greater than or equal to the 85th percentile.
Secondary Outcome Measures
Group Differences in Infant Diet
Families receiving the program will be compared to infants in control families who receive standard ECS content only to determine which group has greater infant diet diversity and quality. Diet will be assessed via three random dietary recall interviews conducted with mothers by phone within 2 weeks of the baseline and post-treatment study visit dates. Trained interviewers, blinded to participant study condition, will employ the United States Department of Agriculture (USDA) automated multiple-pass method (AMPM), a standardized interview approach. Nutrition Data Systems for Research (NDSR) software and foods database will be used to assess total daily energy and macronutrient intake as well as food group servings consumed. Diet diversity will be calculated as the change in number of food groups provided between baseline and post-treatment visits. Diet quality will be assessed by percentage of kilocalories from fat and the number of servings of fruits and vegetables endorsed.
Maternal Feedback on the Intervention - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.
Caregivers in the treatment condition will complete a survey measuring whether parents found the intervention appropriate for their infant, whether sessions occurred at the right time, whether information was presented clearly, whether they knew how to implement the recommendations, whether the intervention was helpful, whether they were satisfied with the intervention, and whether they would recommend the intervention to a friend/family member/coworker. Each satisfaction attribute will be assessed on a 1-5 Likert scale with higher scores indicating more positive views of the program. Parents will also provide qualitative information on what additional information should be included in the intervention, what information was not helpful, what should be changed about the intervention, and what should stay the same about the intervention.
Full Information
NCT ID
NCT04977947
First Posted
May 20, 2021
Last Updated
December 28, 2022
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04977947
Brief Title
Healthy Eating for My Infant (HEMI)
Official Title
Reducing Health Disparities Through an Adaptive Healthy Eating Program for Underserved Infants in a Home Visiting Program
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
September 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infants from underserved and minority backgrounds are at increased risk for obesity and poor feeding and nutrition outcomes, but obesity prevention programs tailored specifically to the needs of these infants are lacking. The current study takes a community-engaged approach to development and delivery of an adaptively tailored obesity prevention program delivered via home visiting to target infant eating and feeding (Healthy Eating for My Infant; HEMI).
Detailed Description
Poor dietary habits and obesity-risk begin early in infancy. Infants from underserved and minority backgrounds experience disparate rates of poor nutritional outcomes and subsequent health disparities related to obesity. Each infant and their family experiences a unique set of risk factors and barriers to healthy eating. However, obesity prevention programs that are culturally and contextually relevant for underserved families and adapted based on the needs of individual families are lacking. The current study will develop an obesity prevention program, Healthy Eating for My Infant (HEMI), using a community-engaged approach involving community members in development and delivery of the program. HEMI targets healthy infant feeding through six monthly sessions with infants 3-8 months old. The program will be delivered as a supplement to an already existing evidence-based home visiting program, Every Child Succeeds (ECS), serving families with primarily low income and ethnic/racial minority backgrounds.
Development of an adaptive and effective obesity prevention program meeting the needs of underserved infants is critical for addressing health disparities in infant eating and obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Obesity prevention, Behavioral intervention, Health disparities, Trauma informed, Child nutrition, Responsive feeding, Infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Families will be assigned to either the treatment or control condition (standard care).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Eating for My Infant Intervention
Arm Type
Experimental
Arm Description
Participants and their parents will participate in a 6 session intervention targeting healthy introduction of complementary foods, and responsive feeding and mealtime behaviors. Intervention sessions will occur when the infant is 3, 4, 5, 6, 7, and 8 months of age.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Eating for My Infant
Other Intervention Name(s)
HEMI
Intervention Description
The intervention targets problem solving to overcome barriers, behavioral rehearsal and practice of healthy behaviors, promoting readiness to change, goal setting, self-monitoring, and behavioral tracking. Two standard treatment modules will be provided to each family by a study interventionist focusing on infant nutritional requirements, responsive feeding, and mealtime behaviors. Two additional treatment modules will be selected to address the unique needs articulated by each family (e.g., food insecurity, eating healthy on a limited income, emotional eating, engaging other caregivers, maternal mental health). Modules will consider the influence of maternal trauma history and mental health on feeding and eating behavior. The intervention also includes two peer counselor-led sessions during which families can discuss implementation of recommendations and barriers to change with a member of their community who can problem solve and support change.
Primary Outcome Measure Information:
Title
Group Differences in Infant BMI
Description
Families receiving the program will be compared to infants in control families who receive standard ECS content only to determine which group has a lower proportion of infants with BMI greater than or equal to the 85th percentile.
Time Frame
The measure of group differences in infant BMI will be completed at post-treatment (when the child is 9 months of age).
Secondary Outcome Measure Information:
Title
Group Differences in Infant Diet
Description
Families receiving the program will be compared to infants in control families who receive standard ECS content only to determine which group has greater infant diet diversity and quality. Diet will be assessed via three random dietary recall interviews conducted with mothers by phone within 2 weeks of the baseline and post-treatment study visit dates. Trained interviewers, blinded to participant study condition, will employ the United States Department of Agriculture (USDA) automated multiple-pass method (AMPM), a standardized interview approach. Nutrition Data Systems for Research (NDSR) software and foods database will be used to assess total daily energy and macronutrient intake as well as food group servings consumed. Diet diversity will be calculated as the change in number of food groups provided between baseline and post-treatment visits. Diet quality will be assessed by percentage of kilocalories from fat and the number of servings of fruits and vegetables endorsed.
Time Frame
The measure of infant diet will be completed within 2 weeks of the baseline visit (when the child is 2 months of age) and again within 2 weeks of the post-treatment visit (when the child is 9 months of age).
Title
Maternal Feedback on the Intervention - Defined as Appropriateness of the Intervention Content and Session Timing, Clarity of Information, Knowledge of the Recommendations, Helpfulness, and Whether They Would Recommend the Intervention to Others.
Description
Caregivers in the treatment condition will complete a survey measuring whether parents found the intervention appropriate for their infant, whether sessions occurred at the right time, whether information was presented clearly, whether they knew how to implement the recommendations, whether the intervention was helpful, whether they were satisfied with the intervention, and whether they would recommend the intervention to a friend/family member/coworker. Each satisfaction attribute will be assessed on a 1-5 Likert scale with higher scores indicating more positive views of the program. Parents will also provide qualitative information on what additional information should be included in the intervention, what information was not helpful, what should be changed about the intervention, and what should stay the same about the intervention.
Time Frame
The measure of feedback on the intervention will be completed at post-treatment (when the child is 9 months of age).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Families enrolled in the Every Child Succeeds (ECS) program
Infant age is < 2 months at study recruitment
Infant born at > 37 weeks gestation
Maternal age is > 18 years
Mother is a singleton
Mother is fluent in English or Spanish
Exclusion Criteria:
Infant has a major medical condition that requires specialized feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathleen Stough, PhD
Phone
5135565589
Email
odarcc@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathleen Stough, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathleen Stough, PhD
Phone
513-556-5589
Email
odarcc@uc.edu
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Woo, PhD
Phone
513-636-4200
Email
jessica.woo@cchmc.org
12. IPD Sharing Statement
Learn more about this trial
Healthy Eating for My Infant (HEMI)
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