Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-06-06
2023-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Healthy Eating for My Infant Intervention
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.
Healthy Eating for My Infant
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.
Control
Participants and their parents will complete baseline and post-treatment study visits to assess study outcomes. They will receive no intervention.
No interventions assigned to this group
Interventions
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Healthy Eating for My Infant
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infant age is \< 2 months at study recruitment
* Infant born at \> 37 weeks gestation
* Infant is a singleton
* Maternal age is \> 18 years (in order to consent for child to participate)
* Mother is fluent in English or Spanish
Exclusion Criteria
2 Months
9 Months
ALL
Yes
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Cathy Stough
Assistant Professor
Principal Investigators
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Cathleen Stough, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2020-0698
Identifier Type: -
Identifier Source: org_study_id
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