Opaque Bottle Study

NCT03711370 | Completed Results

• 2 other identifiers: 2018-164-CPR21HD096236
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Opaque Bottles; Conventional, Clear Bottles

Keywords

infant feeding; feeding interactions; maternal feeding practices; bottle-feeding; opaque bottles

Outcome Measures

Primary Outcomes (3)

• Infant Intake (mL) During the Observed Feeding

  During post-tests, participants in both the Clear Bottle and Opaque Bottle Groups were asked to use the clear bottle during one feeding observation and the opaque bottle during the other feeding across the two post-test assessments, which ensured research assistants remained masked to whether the participant was in the intervention or control group and allowed for within-subject comparison of effects of clear versus opaque bottles on maternal sensitivity and infant intake; order of bottle presentation was counterbalanced. For both opaque and clear bottle-feedings, infant intake was assessed by weighing the infant's bottle before and after each feeding observation using a top-loading balance (SP601 Scout Pro Portable Balance, Ohaus, New Jersey, USA).

  12-week period

• Maternal Sensitivity to Infant Cues

  Mothers' behavior during feeding observations was coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The present analysis focused on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues.

  12-week period

• Infant Weight-for-length Z-scores

  Infants' weight and length were assessed during home-based assessments. Infant weight and length were measured in triplicate using a portable infant scale/infantometer. To minimize bias, infants were always weighed and measured while only wearing a clean diaper and prior to the observed feeding. Weight and length values were standardized to age- and sex-specific weight-for-length z-scores based on the World Health Organization Child Growth Standards (https://www.who.int/tools/child-growth-standards). A z-score of 0 indicates that the child's weight status is at the population median; standard deviations closer to 0 represent healthier weight status. Standard deviations below 0 indicate the child's weight status is below the median, with values \< -2 indicating the child is underweight. Standard deviations above 0 indicate the child's weight status is above the median, with values \> 2 indicating the child is overweight or obese.

  12-week period

Secondary Outcomes (4)

• Change in Infant Waist Circumference

  12-week period

• Change in Infant Triceps Skinfolds z-Scores

  12-week period

• Change in Infant Subscapular Skinfolds z-Scores

  12-week period

• Mothers' Perceptions of the Bottles

  12-week period

Study Arms (2)

Opaque Bottle Group

EXPERIMENTAL

This group was given a set of opaque bottles to use during infant feedings for a full 12-week period.

Other: Opaque Bottle

Clear Bottle Group

ACTIVE COMPARATOR

This group was given a set of clear bottles to use during infant feedings for a full 12-week period.

Other: Clear Bottle

Interventions

Clear Bottle OTHER

These mothers received usual care from their pediatric providers and each mother was given 12 conventional, clear bottles of various sizes (4-12 ounces) that were compatible with a variety of different nipples manufactured by leading bottle companies. Mothers were also given handouts about proper formula preparation and paced bottle-feeding, which included messages about feeding in response to infant cues.

Clear Bottle Group

Opaque Bottle OTHER

These mothers received everything provided to the clear group, but instead received 12 opaque bottles of various sizes (4-12 ounces). These bottles were stainless steel and compatible with a variety of different nipples manufactured by a leading bottle company. Mothers in the intervention group also received an additional handout that contained safety tips for their opaque bottles (e.g., never microwave your bottle).

Opaque Bottle Group

Eligibility Criteria

• Age: 0 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion

San Luis Obispo, California, 93401, United States

Location

Related Publications (2)

• 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.

  PMID: 25445988 BACKGROUND

• 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.

  PMID: 30345622 BACKGROUND

MeSH Terms

Conditions

Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

This study consisted of mothers who were exclusively or predominantly bottle-feeding. We were unable to obtain an objective assessment of adherence, daily feeding patterns, or detailed information regarding the extent to which non-maternal caregivers (e.g., fathers, daycare providers) used clear versus opaque bottles with infants.

Results Point of Contact

• Title: Dr. Alison Ventura
• Organization: California Polytechnic State University

akventur@calpoly.edu

(805) 756-5693

Study Officials

• Alison K Ventura, PhD

  California Polytechnic State University-San Luis Obispo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The video coders were masked during video analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 18, 2018
• Study Start: December 1, 2018
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: August 23, 2023
• Results First Posted: August 23, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)