Obesity Clinical Trial
Official title:
Healthy Babies Through Infant Centered Feeding
Poor feeding practices during infancy contribute to obesity risk because they interfere with infant feeding self-regulation and appropriate growth patterns as infants transition from human milk and/or formula-based diets to solid foods. The goal of the project is to provide an educational intervention that fosters appropriate maternal responsiveness, feeding styles, and feeding practices via infant-centered feeding.
The long-term goal of this integrated project is to contribute to curbing the rising rates
of childhood obesity through an effective, multi-component, relationship skill-building and
educational intervention that fosters infant-centered feeding to promote appropriate
maternal responsiveness, feeding styles, and feeding practices as infants transition to
solid foods.
Research Objectives: To evaluate effectiveness of Healthy Babies (HB) compared to the
Expanded Food and Nutrition Education Program (EFNEP) at two points in time (when the infant
is 6 and 12 months of age) for mothers of infants on maternal responsiveness, feeding style,
and feeding practices as infants' transition to solid foods, and to compare infant feeding
self-regulation and growth pattern of infants at 6 and 12 months of age between the two
groups, HB and EFNEP.
Hypothesis: Compared to mothers of infants who receive traditional EFNEP lessons, mothers
who receive HB lessons will achieve an improvement (when the infant is 6 months old that is
sustained over time when the infant is 12 months of age) on:
- Maternal responsiveness (measured by appropriately interpreting and responding to
infant cues when transitioning their infants to solid foods on the Parent-Child
Interaction-Feeding Scale [PCI-F]).
- Maternal feeding styles (measured by feeding beliefs and behaviors on the Infant
Feeding Styles Questionnaire).
- Feeding practices (measured by use of appropriate feeding practices when transitioning
their infants to solid foods on the PCI-F).
Research Question: How do infants in the HB (intervention) group compare to the infants in
the traditional EFNEP group when the infant is 6 and 12 months old on:
- Infant feeding self-regulation (measured by clarity of cues and feeding responsiveness
on the PCI-F).
- Infant growth patterns (measured by growth charts).
Extension Objective: To evaluate feasibility, fidelity, and educational effectiveness of the
HB intervention. (Process Evaluation)
Research Question: What is the feasibility of integration within Extension by
paraprofessionals who deliver HB and for mothers of infants' who receive the HB lessons,
related to:
- Paraprofessionals' training, ability to deliver the intervention (fidelity), and
satisfaction with the intervention; and
- Mothers' acceptance (recruitment), completion (retention), and satisfaction with the
intervention.
Research Question: What is the educational effect of the intervention on maternal knowledge,
attitudes, and self-efficacy related to infant feeding?
Research Design. The study will use a randomized clinical trial design in which participants
from Michigan (MI) and Colorado (CO) will be randomly assigned to the HB intervention or
control (EFNEP) group. The HB intervention, delivered by paraprofessionals (educators), is
designed to foster appropriate maternal responsiveness, feeding style, and feeding
practices. Participants will be blinded to their group assignment. Data will be collected at
three time points by a separate data collection team (not educators): baseline (before the
first lesson), follow-up (when infant is six months old), and post follow-up (when infant is
12 months old). These time points have been selected based on the infant's age, such that
when an infant is six months old, this is the usual time frame when introducing solid food
is recommended to be initiated for all infants, and at 12 months, infants should have an
established eating pattern of solid foods. Thus, these points in time were selected rather
than immediately following the lessons for consistency in infant age. The age of the infant
at time of enrollment will be standardized for timing of the intervention, such that the
intervention will begin for all infants between 1 and 4 months of age. Three time points are
included to make statistical comparisons and assess the sustainability of changes. Process
data will be collected throughout the study.
Participant Recruitment. A total of 546 mother-infant were recruited through community
agencies providing services to pregnant women and mothers of infants in Michigan and
Colorado (i.e., EFNEP, Breast Feeding Initiative, and Women, Infants and Children's Special
Supplemental Nutrition Program for Women, Infants, and Children). Given each state's
demographics, Michigan is has a higher proportion of Black minority dyads and Colorado a
higher proportion of Hispanic/Latina dyads. Though race/ethnicity/culture is not a specific
focus of the study, the sample size will allow us to examine race/ethnic/cultural
similarities and differences.
The investigators have recruited of 546 eligible families in MI and CO which will allow for
25% attrition (at each data collection), leaving 278 families at post follow-up (when infant
is 12 months old) available for data analysis.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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