Opaque Bottle Study

California Polytechnic State University (Cal Poly)

Status

Completed

Conditions

Conventional, Clear Bottles

Opaque Bottles

Treatments

Other: Opaque Bottle

Other: Clear Bottle

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03711370

R21HD096236 (U.S. NIH Grant/Contract)

2018-164-CP

Details and patient eligibility

About

The proposed research aimed to conduct an intervention study assessing the effect of feeding mode (clear versus opaque bottle) on the quality and outcome of infant feeding interactions.

Full description

The overall objective of the proposed pilot/feasibility study was to evaluate a home- and family-based intervention to increase bottle-feeding mothers' responsiveness to infant satiety cues and moderate bottle-feeding infants' rates of weight gain over a 12-week period. Specifically, the investigators propose to provide mothers with opaque, weighted bottles (instead of conventional, clear bottles) with which to feed their infants; based on preliminary studies, it is hypothesized that removal of mothers' abilities to assess the amount the infant consumes during feeding will facilitate abilities to feed in response to infant satiation cues.

For the proposed research, predominantly bottle-feeding mothers with <6-month-old infants were randomized to use opaque bottles (intervention or opaque group) or to use clear bottles (control or clear group). The investigators conducted home-based assessments at the beginning and end of the 12-week study period during which mothers were video-recorded feeding their infants using clear or opaque bottles. Two interim assessments will be conducted (after 2 and 6 weeks) to assess feeding adequacy and fidelity to the intervention. During feeding observations, infant intake were assessed via bottle weight. Video-records were later coded for maternal responsiveness to infant cues using the Nursing Child Assessment Parent-Child Interaction Feeding Scale (NCAFS). It was hypothesized that mothers in the opaque group will feed their infants less and show greater increases in their levels of responsiveness to infant cues compared to mothers in the clear group. Infants' weight and length were measured at the beginning and end of the 12-week study; weight-for-length z-scores (WLZ) were calculated using the World Health Organization (WHO) Growth Standards. It was hypothesized that WLZ change would be significantly lower for infants in the opaque compared to the clear group. The feasibility of the intervention was also explored by collecting and analyzing objective and subjective data related to the extent to which mothers use and like the bottles, and whether characteristics of mothers or infants moderate intervention effects. The proposed feasibility study is a critical step toward understanding mothers' acceptance and use of opaque bottles compared to conventional, clear bottles, and the potential for opaque bottles to improve the outcome of feeding interactions in home-based settings.

Enrollment

152 patients

Sex

All

Ages

Under 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

mothers 18-40-years of age
infants <24-weeks of age
predominantly bottle-feeding (>50% of feedings)
mother predominantly or solely responsible for infant feeding
dyad has a pediatrician and plans to attend infant well-visits
mother is willing to use stainless-steel bottles and to provide the study with her current bottles, which would be returned after study completion
prior to the introduction of solid foods.

Exclusion criteria