Responsive Feeding Study

Bottle Feeding Clinical Trial

— RFS  

Official title:

Responsive Feeding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284152
• Other study ID #: 809649
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: November 3, 2014
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2014
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In the present study, we tested a novel approach to understanding infant bottle-feeding interactions: experimentally manipulating bottle-feeding conditions to better understand maternal and infant influences on overfeeding, as well as individual differences in risk for overfeeding. Specifically, we observed mother-infant dyads during a typical, "mother-led" feeding, during which mothers were given no instruction regarding how or how much to feed their infants (hereafter referred to as a "typical feeding" [TF]), as well as during an "infant-led" (IL) feeding, wherein we minimized the mothers' influence on the feeding and ensured the feed was in response to the infants' hunger and fullness cues. Using this within-subject, objective, and experimental approach, the present study aimed to: 1) directly measure the extent to which overfeeding occurs during bottle-feeding and 2) describe the characteristics of infants and mothers that overfeed during bottle-feeding.

Description:

Each mother-infant dyad came to our laboratory on two different days, separated by an average of 2.1 ± 0.4 days. The two testing sessions occurred at the same time of day to control for infants' circadian rhythmicity. Mothers were instructed to bring two of their infants' typical bottles filled with their infants' typical formula to each testing session. Mothers were videotaped while feeding their infants on both days. The first day of testing was always the Typical Feeding (TF) condition because the only instruction given to the mother was: "Please feed your infant as you normally would at home." The second day of testing was always the Infant-Led (IL) condition, wherein we used a protocol developed and established in our laboratory to control for a number of factors to allow for evaluation of infants' hedonic and behavioral responses independent of the parent and experimenter. The feeding protocol during the IL condition entailed the following steps, which were facilitated by the experimenter: (1) feeding sessions began when the experimenter observed the infant displaying signs of hunger (e.g., mouthing, rooting, fussing) and the mother verified that the infant was hungry; (2) the mother was instructed not to talk to her infant and to remain as neutral as possible; (3) the mother was also instructed to feed her infant at his/her customary pace; (4) the experimenter ended the feeding when the infant displayed signs of fullness (e.g., turning head and/or body away from the bottle, biting or chewing on the nipple, spiting the nipple out) on at least three consecutive occasions. If the infant finished the bottle before signaling fullness, the experimenter gave the mother the other bottle to ensure that infant intake was not limited by formula availability. During both study days, consumption during the feeding session was assessed by weighing the bottles before and after each feeding using a top loading balance (model PM 15; Mettler, Greifensee, Switzerland).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Formula-feeding

• Prior to the introduction of solid foods

• Infants 0 to 6 months of age

• Mothers 18 to 40 years of age

Exclusion Criteria:

• Exclusively breast-feeding

• Preterm

• Medical conditions that interfered with feeding

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bottle Feeding

Intervention

Behavioral:
• infant-led feeding
mothers' feeding practices and infant intakes were compared between a typical feeding condition and an infant-led feeding condition, where the experimenter ensured the feeding was in response to infant hunger and fullness cues.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania
United States	Monell Chemical Senses Center	Philadelphia	Pennsylvania
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Monell Chemical Senses Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ventura AK, Inamdar LB, Mennella JA. Consistency in infants' behavioural signalling of satiation during bottle-feeding. Pediatr Obes. 2015 Jun;10(3):180-7. doi: 10.1111/ijpo.250. Epub 2014 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Intake	Infant intake was assessed by weighing the bottle before and after the feeding	3-hour period	No