Opaque Bottle Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Bottle-Type of Infant Feeding Behavior

NCT02519179

Bottle Feeding

COMPLETED NA

Breast Versus Bottle Study

NCT03704051

Breastfeeding Bottle Feeding

COMPLETED

Influence of Bottle-Type on Infant Feeding Behaviors

NCT02111694

Conventional Clear Bottle Opaque Weighted Bottle

COMPLETED NA

Short-term Effects of Paced Bottle-Feeding on Feeding Interactions

NCT05780944

Mother-Infant Interaction Breastfeeding Bottle Feeding

COMPLETED NA

Prevention of Obesity in Infants of Overweight and Obese Women

NCT04782063

Infant Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opaque Bottles Conventional, Clear Bottles

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The video coders were masked during video analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opaque Bottle Group

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

Group Type EXPERIMENTAL

Opaque Bottle

Intervention Type 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).

Clear Bottle Group

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

Group Type ACTIVE_COMPARATOR

Clear Bottle

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clear Bottle

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.

Intervention Type OTHER

Opaque Bottle

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

0 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes