Healthy Babies Through Infant Centered Feeding

NCT01816516 | Completed DMC

• 1 other identifier: 2009-55215-05220
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Overweight; Obesity; Infant Overnutrition; Feeding Behavior; Feeding Patterns

Keywords

childhood obesity; low-income; maternal responsiveness; infant feeding; infant feeding practices; infant feeding style; primary prevention

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Change in Baseline in Maternal Responsiveness at 12 months

Secondary Outcomes (2)

• Change from Baseline in Feeding Practices assessed at different time points (6 months and 12 months)

  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

Other Outcomes (4)

• Change from Baseline in Feeding Styles assessed at different times (6 months and 12 months)

  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 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 in Baseline in Feeding Style at 12 months

Study Arms (2)

Healthy Babies

EXPERIMENTAL

Participants receive the Healthy Babies curriculum via 6 in home lessons and 3 follow up telephone calls delivered by Extension paraprofessionals.

Behavioral: Healthy Babies

EFNEP

ACTIVE COMPARATOR

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

Interventions

Healthy Babies BEHAVIORAL

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.

Healthy Babies

Expanded Food and Nutrition Education Program BEHAVIORAL

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.

EFNEP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers aged 18 or older with one, two or three children
• Infants of low-risk births aged birth to 4 months who have not been introduced to solid foods
• Low income (those who qualify for EFNEP, income at or below 185% - 200% of the federal poverty level)
• Infants born between 37 and 42 weeks gestational age with birth weight between 5 pounds 8 ounces and 8 pounds 13 ounces

You may not qualify if:

• Male caregivers
• Mothers and/or infants diagnosed with feeding or eating disorders

Sponsors & Collaborators

• Michigan State University: lead
• Department of Health and Human Services: collaborator
• Colorado State University: collaborator

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (2)

• Horodynski MA, Olson B, Baker S, Brophy-Herb H, Auld G, Van Egeren L, Lindau J, Singleterry L. Healthy babies through infant-centered feeding protocol: an intervention targeting early childhood obesity in vulnerable populations. BMC Public Health. 2011 Nov 15;11:868. doi: 10.1186/1471-2458-11-868.

  PMID: 22085421 BACKGROUND

• Horodynski MA, Baker S, Van Egeren L, Olson B, Brophy-Herb H, Auld G. The healthy babies curriculum. J Nutr Educ Behav. 2014 Mar-Apr;46(2):151-2. doi: 10.1016/j.jneb.2013.10.002. Epub 2013 Nov 23. No abstract available.

  PMID: 24280320 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Infant Nutrition Disorders; Feeding Behavior; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Mildred Horodynski, PhD, RN

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 22, 2013
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

US (2)