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Opaque Bottle Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03711370
Enrollment
152
Registered
2018-10-18
Start date
2018-12-01
Completion date
2022-07-10
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conventional, Clear Bottles, Opaque Bottles

Keywords

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

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.

Interventions

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.

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).

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
California Polytechnic State University-San Luis Obispo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The video coders were masked during video analysis.

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.

Eligibility

Sex/Gender
ALL
Age
0 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant Intake (mL) During the Observed Feeding12-week periodDuring 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 Cues12-week periodMothers' 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-scores12-week periodInfants' 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.

Secondary

MeasureTime frameDescription
Change in Infant Waist Circumference12-week periodInfant 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.
Mothers' Perceptions of the Bottles12-week periodMothers' perceptions of their assigned bottles, including any perceived barriers to their use, were assessed via a questionnaire developed by the investigators.
Change in Infant Triceps Skinfolds z-Scores12-week periodTriceps 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.
Change in Infant Subscapular Skinfolds z-Scores12-week periodSubscapular 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.

Countries

United States

Participant flow

Recruitment details

Recruitment occurred between December 2018 and May 2022. Mothers with young infants were recruited through local radio station ads; targeted social media ads; Supplemental Nutrition Assistance Program for Women, Infants, and Children (WIC) offices; perinatal education classes; and pediatric offices; as well as through a list of past participants who asked to be notified of future studies.

Pre-assignment details

Participants engaged in two initial pre-test assessments that occurred in participants' homes or via video conference. Pre-tests were separated by no more than 2 weeks (average time between pre-tests=2.5+/-2.0 days, range=1-8 days). After the second pre-test assessment, participants were randomized to the control or intervention groups.

Participants by arm

ArmCount
Clear Bottle Group
This group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
76
Opaque Bottle Group
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
76
Total152

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up1610
Overall StudyPre-test or Post-test visits were >2 weeks apart06

Baseline characteristics

CharacteristicTotalOpaque Bottle GroupClear Bottle Group
Age, Continuous2.9 months
STANDARD_DEVIATION 1.4
30.9 years
STANDARD_DEVIATION 5.2
3.0 months
STANDARD_DEVIATION 1.5
Race/Ethnicity, Customized
Race/Ethnicity
Asian
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
55 Participants29 Participants26 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Non-Hispanic White
18 Participants8 Participants10 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
1 Participants1 Participants0 Participants
Region of Enrollment
United States
152 participants76 participants76 participants
Sex: Female, Male
Female
40 Participants38 Participants38 Participants
Sex: Female, Male
Male
36 Participants0 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 380 / 380 / 380 / 38
other
Total, other adverse events
0 / 380 / 380 / 380 / 38
serious
Total, serious adverse events
0 / 380 / 380 / 380 / 38

Outcome results

Primary

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).

Time frame: 12-week period

Population: 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)

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Clear Bottle Group - Clear Bottle ConditionInfant Intake (mL) During the Observed Feeding116.7 mLStandard Error 10.1
Clear Bottle Group - Opaque Bottle Condition.Infant Intake (mL) During the Observed Feeding119.5 mLStandard Error 10
Opaque Bottle Group - Clear Bottle ConditionInfant Intake (mL) During the Observed Feeding107.5 mLStandard Error 10.2
Opaque Bottle Group - Opaque Bottle ConditionInfant Intake (mL) During the Observed Feeding114.9 mLStandard Error 10.1
p-value: 0.76Mixed Models Analysis
Primary

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.

Time frame: 12-week period

Population: 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.

ArmMeasureValue (MEAN)Dispersion
Clear Bottle Group - Clear Bottle ConditionInfant Weight-for-length Z-scores0.22 z-scoreStandard Error 0.16
Clear Bottle Group - Opaque Bottle Condition.Infant Weight-for-length Z-scores0.69 z-scoreStandard Error 0.15
p-value: 0.02Regression, Linear
Primary

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.

Time frame: 12-week period

Population: 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)

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Clear Bottle Group - Clear Bottle ConditionMaternal Sensitivity to Infant Cues12.3 score on a scaleStandard Error 0.4
Clear Bottle Group - Opaque Bottle Condition.Maternal Sensitivity to Infant Cues12.6 score on a scaleStandard Error 0.4
Opaque Bottle Group - Clear Bottle ConditionMaternal Sensitivity to Infant Cues12.2 score on a scaleStandard Error 0.4
Opaque Bottle Group - Opaque Bottle ConditionMaternal Sensitivity to Infant Cues12.2 score on a scaleStandard Error 0.4
p-value: 0.64Mixed Models Analysis
Secondary

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.

Time frame: 12-week period

Population: 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, skinfold data could not be obtained for n=23 dyads in the Clear Bottle Group and n=23 dyads in the Opaque Bottle Group.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Clear Bottle Group - Clear Bottle ConditionChange in Infant Subscapular Skinfolds z-Scores0.67 z-scoresStandard Error 0.22
Clear Bottle Group - Opaque Bottle Condition.Change in Infant Subscapular Skinfolds z-Scores0.37 z-scoresStandard Error 0.25
Secondary

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.

Time frame: 12-week period

Population: 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, skinfold data could not be obtained for n=23 dyads in the Clear Bottle Group and n=23 dyads in the Opaque Bottle Group.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Clear Bottle Group - Clear Bottle ConditionChange in Infant Triceps Skinfolds z-Scores-0.52 z-scoresStandard Error 0.4
Clear Bottle Group - Opaque Bottle Condition.Change in Infant Triceps Skinfolds z-Scores-0.77 z-scoresStandard Error 0.47
p-value: 0.7Regression, Linear
Secondary

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.

Time frame: 12-week period

Population: 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, waist circumference data could not be obtained for n=16 dyads in the Clear Bottle Group and n=16 dyads in the Opaque Bottle Group.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Clear Bottle Group - Clear Bottle ConditionChange in Infant Waist Circumference44.7 centimetersStandard Error 0.59
Clear Bottle Group - Opaque Bottle Condition.Change in Infant Waist Circumference43.1 centimetersStandard Error 0.63
p-value: 0.07Regression, Linear
Secondary

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.

Time frame: 12-week period

Population: 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)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Clear Bottle Group - Clear Bottle ConditionMothers' Perceptions of the Bottlesindicated they would continue to use their assigned bottle after the study ended24 Participants
Clear Bottle Group - Clear Bottle ConditionMothers' Perceptions of the Bottlesindicated they would not continue to use their assigned bottle after the study ended6 Participants
Clear Bottle Group - Opaque Bottle Condition.Mothers' Perceptions of the Bottlesindicated they would not continue to use their assigned bottle after the study ended6 Participants
Clear Bottle Group - Opaque Bottle Condition.Mothers' Perceptions of the Bottlesindicated they would continue to use their assigned bottle after the study ended24 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026