Clinical trial NCT03711370: Opaque Bottle Study
Official title: A Pilot-Feasibility of a Home-based Intervention to Reduce Obesity Risk for Bottle-fed Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opaque Bottles
Conventional, Clear Bottles
Keywords: infant feeding
feeding interactions
maternal feeding practices
bottle-feeding
opaque bottles
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-10-18
Enrollment: 152
Sex: ALL
Minimum age (years): 0
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants were randomly assigned to either the opaque bottle group or the clear bottle group. Mothers were asked to use their assigned bottle type to feed their infant for a full 12-week period. Pre-tests were given before the 12-week period and post-tests occured after the 12-week period. During these tests, we observed each mother using the clear bottle to feed her infant on one visit and the opaque bottle on another visit. The order of these conditions was randomized and counterbalanced.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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:

* preterm birth (i.e., gestational age \<37 weeks)
* low birth weight (\<2500 g)
* maternal smoking during pregnancy
* current or past medical conditions that interfere with oral feeding
* history of slow growth or failure to thrive
* weight for length percentile \<5th
* diagnosed developmental delay (e.g., Down's syndrome)
* currently using opaque bottles

Primary outcomes:
measure: Infant Intake (mL) During the Observed Feeding
timeFrame: 12-week period
measure: Maternal Sensitivity to Infant Cues
timeFrame: 12-week period
measure: Infant Weight-for-length Z-scores
timeFrame: 12-week period
Secondary outcomes:
measure: Change in Infant Waist Circumference
timeFrame: 12-week period
measure: Change in Infant Triceps Skinfolds z-Scores
timeFrame: 12-week period
measure: Change in Infant Subscapular Skinfolds z-Scores
timeFrame: 12-week period
measure: Mothers' Perceptions of the Bottles
timeFrame: 12-week period
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion
state: California
Study officials:
affiliation: California Polytechnic State University-San Luis Obispo
name: Alison K Ventura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.
citation: Ventura AK, Hernandez A. Effects of opaque, weighted bottles on maternal sensitivity and infant intake. Matern Child Nutr. 2019 Apr;15(2):e12737. doi: 10.1111/mcn.12737. Epub 2018 Nov 22.