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OpenTrials
Completed

NCT Number: NCT02519179

Influence of Bottle-Type of Infant Feeding Behavior

The objective this research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.

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Key information

Conditions

Bottle Feeding Behavior Feeding Behavior

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University

San Luis Obispo, California, 93401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mothers must be 18 years or older
  • Infants must be between 0-6 months of age
  • Infants must be prior to the introduction of solid foods

Exclusion criteria

  • Preterm birth
  • Medical conditions that interfere with feeding

Treatment and study plan

Opaque, weighted bottle

Behavioral

This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.

Clear, conventional bottle

Behavioral

This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle.

Primary outcomes

  1. Infant intake

    Time frame: 3-hour period

    Infant intake within a feeding (mL) assessed by weighing the bottle before and after a feeding.

  2. Maternal responsiveness

    Time frame: 3-hour period

    Maternal responsiveness to infant cues during a feeding assessed by Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale.

Secondary outcomes

  1. Maternal acceptance/perception of intervention

    Time frame: 3-hour period

    Maternal perception/acceptance of the bottles during a feeding assessed through a mixed methods interview.

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Registry information

Acronym: OBS-II

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 10, 2015
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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