An interventional study of Healthy Babies and Expanded Food and Nutrition Education Program in Overweight, Obesity and Infant Overnutrition, sponsored by Michigan State University. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by Michigan State University · Not applicable, Interventional, and Prevention
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:
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:
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:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 546 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive the Healthy Babies curriculum via 6 in home lessons and 3 follow up telephone calls delivered by Extension paraprofessionals.
Behavioral: Healthy Babies
Participants receive the Expanded Food and Nutrition Education Program (EFNEP) curriculum via 6 in home lessons delivered by Extension paraprofessionals.
Behavioral: Expanded Food and Nutrition Education Program
Each lesson is designed to promote the development of healthy infant eating, and incorporates research-based information, opportunities for mothers to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques. During lessons, mothers engage in activities in support of lesson goals. Intervention strategies focusing on feeding practices will include modification of the feeding environment (e.g., television off during feeding). The telephone contacts, 10 minutes in length, made at 6, 8, and 10 months, reinforce key concepts in the lessons after conclusion of the intervention to maintain effects.
Core EFNEP concepts are United States Department of Agriculture (USDA) My Pyramid, fruits, vegetables, meats, whole grains, food safety, and food resource management. Educators for the EFNEP group will use the EFNEP lessons which address basic knowledge customized for families with infants. Mothers in the EFNEP group will receive a series of six lessons from the nutrition education program offered in each state; they provide a series of lessons focused on nutrition education for families and do not include extensive content on feeding infants.
Change from Baseline in Maternal Responsiveness at different time points (e.g., 6 months, 12 months)
Change in maternal responsiveness is measured through an Observational measure (mother-infant feeding interaction): Maternal Responsiveness via Parent-Child Interaction-Feeding Scale (PCI-F) (Formerly Nursing Child Assessment of Feeding Scale)
Time frame: Change from Baseline in Maternal Responsiveness at 6 months
Change in Baseline in Maternal Responsiveness at different time points (6 months and 12 months)
Change in Baseline in maternal responsiveness at 12 months is measured via an observational tool: Parent-Child Interaction -Feeding Scale.
Time frame: Change in Baseline in Maternal Responsiveness at 12 months
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Change in Feeding Practices is assessed via The Infant Feeding Scale (IFS)
Time frame: Change in Baseline in Feeding Practices at 6 months
Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)
Change in Baseline in Feeding Practices at 12 months is assessed using the Infant Feeding Scale
Time frame: Change in Baseline in feeding practices at 12 months
Change from Baseline in Feeding Styles assessed at different times (6 months and 12 months)
Change from Baseline in Feeding Style at 6 months is assessed via the Infant Feeding Styles Questionnaire (IFSQ)
Time frame: Change in Baseline in Feeding Style at 6 months
Change from Baseline in Infant Anthropometrics (infant weight and recumbent length) assessed at different time points (6 months and 12 months)
Change from Baseline in Infant weight and recumbent length at 6 months measured using standardized Centers for Disease Control measurement protocol for in-home infant weight and recumbent length.
Time frame: Change in Baseline in infant weight and length in 6 months
Change from Baseline in Feeding Style assessed at different time points (6 months and 12 months)
Change from Baseline in Feeding Style at 12 months is assessed using the Infant Feeding Style Questionnaire.
Time frame: Change in Baseline in Feeding Style at 12 months
Change from Baseline in infant anthropometrics (infant weight and recumbent length) assessed at different time points (6 months and 12 months)
Change from Baseline in infant weight and recumbent length at 12 months is assessed using the standardized Centers for Disease Control in-home measurement protocol for infant weight and recumbent length.
Time frame: Change in Baseline in infant weight and recumbent length at 12 months
The record gives a start of Feb 2010, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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