Opaque Bottle Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot-Feasibility of a Home-based Intervention to Reduce Obesity Risk for Bottle-fed Infants

Conditions
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Opaque Bottles, Conventional, Clear Bottles

Intervention / Treatment
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* Other: Clear Bottle
* Other: Opaque Bottle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opaque Bottle Group<br>This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. | Other: Opaque Bottle<br>* 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).<br>|
| Active Comparator: Clear Bottle Group<br>This group was given a set of clear bottles to use during infant feedings for a full 12-week period. | Other: Clear Bottle<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Infant Waist Circumference | Infant central adiposity was assessed via a waist circumference measurement, which was assessed during home-based assessments by trained research assistants. Waist circumference was assessed in triplicate using a study-specific Gulick II tape measure. | 12-week period | 
| Change in Infant Triceps Skinfolds z-Scores | Triceps skinfold thickness, a marker of infant adiposity, was assessed during home-based assessments by trained research assistants. A study-specific Harpenden caliper was used for this assessment. Triceps skinfold thickness values were standardized to age- and sex-specific 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 adiposity is at the population median. Standard deviations below 0 indicate the child's adiposity is below the median and standard deviations above 0 indicate the child's adiposity is above the median. Standard deviations closer to 0 represent healthier levels of adiposity. | 12-week period | 
| Change in Infant Subscapular Skinfolds z-Scores | Subscapular skinfold thickness, a marker of infant adiposity, was assessed during home-based assessments by trained research assistants. A study-specific Harpenden caliper was used for this assessment. Subscapular skinfold thickness values were standardized to age- and sex-specific 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 adiposity is at the population median. Standard deviations below 0 indicate the child's adiposity is below the median and standard deviations above 0 indicate the child's adiposity is above the median. Standard deviations closer to 0 represent healthier levels of adiposity. | 12-week period | 
| Mothers' Perceptions of the Bottles | Mothers' perceptions of their assigned bottles, including any perceived barriers to their use, were assessed via a questionnaire developed by the investigators. | 12-week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant feeding, feeding interactions, maternal feeding practices, bottle-feeding, opaque bottles