Opaque BottlesNCT03711370

Opaque Bottle Study

A study testing Clear Bottle and Opaque Bottle in people with Opaque Bottles and Conventional, Clear Bottles, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 0 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Opaque Bottles, Conventional, Clear Bottles
What is being tested?: Clear Bottle and Opaque Bottle
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2018to 10 Jul 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 0 to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion
San Luis Obispo, California, 93401

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Opaque Bottles, Conventional, Clear Bottles
Being tested: Clear Bottle, Opaque Bottle
Keywords: infant feeding, feeding interactions, maternal feeding practices, bottle-feeding, opaque bottles
Medical subject headings: Bottle Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clear BottleOther
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.
Opaque BottleOther
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).

Study groups in NCT03711370
Study group	Role	What they receive
Opaque Bottle Group	Experimental	This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. Receives: 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. Receives: Other: Clear Bottle

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 12-week period

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-week period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201810 Jul 2022

First posted18 Oct 2018
Study start1 Dec 2018
Primary completion10 Jul 2022
Study completion10 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Opaque BottlesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03711370
Sponsor's protocol ID: 2018-164-CP
Other IDs: R21HD096236
Status last verified: Jul 2023
First submitted: 14 Oct 2018
Last updated: 23 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We do not currently plan to make individual participant data available to other researchers.

Publications

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.
PubMed 25445988
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.
PubMed 30345622

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot-Feasibility of a Home-based Intervention to Reduce Obesity Risk for Bottle-fed Infants
ClinicalTrials.gov ID: NCT03711370
Acronym / sponsor ID: 2018-164-CP
Conditions: Opaque Bottles, Conventional, Clear Bottles
Keywords: infant feeding, feeding interactions, maternal feeding practices, bottle-feeding, opaque bottles
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: California Polytechnic State University-San Luis ObispoUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Dec 2018 (actual)
Primary completion: 10 Jul 2022 (actual)
Study completion: 10 Jul 2022 (actual)
First posted: 18 Oct 2018 (actual)
Results: Posted 23 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Opaque Bottle Group	Experimental	Other: Opaque BottleThis group was given a set of opaque bottles to use during infant feedings for a full 12-week period.
Clear Bottle Group	Active comparator	Other: Clear BottleThis group was given a set of clear bottles to use during infant feedings for a full 12-week period.

Who may qualify

Ages: 0 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clear BottleThese 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.	Other	Clear Bottle Group
Opaque BottleThese 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).	Other	Opaque Bottle Group

Primary outcome

Infant Intake (mL) During the Observed Feeding
Time frame: 12-week period
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).
Maternal Sensitivity to Infant Cues
Time frame: 12-week period
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.
Infant Weight-for-length Z-scores
Time frame: 12-week period
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.

4 secondary outcomes

Change in Infant Waist Circumference
Time frame: 12-week period
Change in Infant Triceps Skinfolds z-Scores
Time frame: 12-week period
Change in Infant Subscapular Skinfolds z-Scores
Time frame: 12-week period
Mothers' Perceptions of the Bottles
Time frame: 12-week period

Results and safety

Results posted to the registry on 23 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clear Bottle Group	76	60
Opaque Bottle Group	76	60

Primary outcome: Infant Intake (mL) During the Observed Feeding

Time frame: 12-week period. Least squares mean (Standard Error). Unit: mL

Measure	Clear Bottle Group - Clear Bottle Condition n = 30	Clear Bottle Group - Opaque Bottle Condition. n = 30	Opaque Bottle Group - Clear Bottle Condition n = 30	Opaque Bottle Group - Opaque Bottle Condition n = 30
Value	116.7 (10.1)	119.5 (10.0)	107.5 (10.2)	114.9 (10.1)

Clear Bottle Group - Clear Bottle Condition vs Clear Bottle Group - Opaque Bottle Condition. vs Opaque Bottle Group - Clear Bottle Condition vs Opaque Bottle Group - Opaque Bottle Condition: p = 0.76, Mixed Models Analysis

Population analysed: Overall Number of Participants Analyzed for each group (n=30) is not consistent with the number of participants indicated in the Participant Flow module because data were analyzed at the level of the dyad (n = 30 dyads per group), not at the level of each individual member of the dyad (n = 60 individuals per group, which represents 30 mothers + 30 infants)

Primary outcome: Maternal Sensitivity to Infant Cues

Time frame: 12-week period. Least squares mean (Standard Error). Unit: score on a scale

Measure	Clear Bottle Group - Clear Bottle Condition n = 30	Clear Bottle Group - Opaque Bottle Condition n = 30	Opaque Bottle Group - Clear Bottle Condition n = 30	Opaque Bottle Group - Opaque Bottle Condition n = 30
Value	12.3 (0.4)	12.6 (0.4)	12.2 (0.4)	12.2 (0.4)

Clear Bottle Group - Clear Bottle Condition vs Clear Bottle Group - Opaque Bottle Condition vs Opaque Bottle Group - Clear Bottle Condition vs Opaque Bottle Group - Opaque Bottle Condition: p = 0.64, Mixed Models Analysis

Primary outcome: Infant Weight-for-length Z-scores

Time frame: 12-week period. Mean (Standard Error). Unit: z-score

Measure	Clear Bottle Group n = 18	Opaque Bottle Group n = 17
Value	0.22 (0.16)	0.69 (0.15)

Clear Bottle Group vs Opaque Bottle Group: p = 0.02, Regression, Linear

Population analysed: Overall Number of Participants Analyzed for each group is not consistent with the number of participants indicated in the Participant Flow module because data were analyzed at the level of the dyad (n = 30 dyads per group), not at the level of each individual member of the dyad (n = 60 individuals per group, which represents 30 mothers + 30 infants). In addition, weight-for-length data were missing for n=12 dyads in the Clear Bottle Group and n=13 dyads in the Opaque Bottle Group.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3-5 months after randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clear Bottle Group - Mothers	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Clear Bottle Group - Infants	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Opaque Bottle Group - Mothers	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Opaque Bottle Group - Infants	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25445988Ventura 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.
Background: PubMed 30345622Ventura 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.
Individual participant dataSharing planned: No. We do not currently plan to make individual participant data available to other researchers.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison K Ventura, PhD principal investigator

California Polytechnic State University-San Luis Obispo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infant Intake (mL) During the Observed Feeding (time frame: 12-week period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03711370, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.