Trial Outcomes & Findings for Opaque Bottle Study (NCT NCT03711370)
NCT ID: NCT03711370
Last Updated: 2023-08-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
152 participants
Primary outcome timeframe
12-week period
Results posted on
2023-08-23
Participant Flow
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.
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.
Participant milestones
| Measure |
Clear Bottle Group
This group was given a set of clear bottles that were to be used 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 a handouts about proper formula preparation and paced bottle-feeding, which includes messages about feeding in response to infant cues.
|
Opaque Bottle Group
This group was given a set of opaque bottles that are to be used 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, weighted bottles of various sizes (4-12 ounces). These bottles were stainless steel and compatible with a variety of different nipples manufactured by leading bottle companies. Mothers in the intervention group received an additional handout that contained safety tips for their opaque bottles (e.g., never microwave your bottle).
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
Pre-Test: Clear Bottle Feeding Condition
|
76
|
76
|
|
Overall Study
Pre-Test: Opaque Bottle Feeding Condition
|
76
|
76
|
|
Overall Study
Post-test: Clear Bottle Feeding Condition
|
60
|
66
|
|
Overall Study
Post-test: Opaque Bottle Feeding Condition
|
60
|
66
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
Clear Bottle Group
This group was given a set of clear bottles that were to be used 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 a handouts about proper formula preparation and paced bottle-feeding, which includes messages about feeding in response to infant cues.
|
Opaque Bottle Group
This group was given a set of opaque bottles that are to be used 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, weighted bottles of various sizes (4-12 ounces). These bottles were stainless steel and compatible with a variety of different nipples manufactured by leading bottle companies. Mothers in the intervention group received an additional handout that contained safety tips for their opaque bottles (e.g., never microwave your bottle).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
10
|
|
Overall Study
Pre-test or Post-test visits were >2 weeks apart
|
0
|
6
|
Baseline Characteristics
Measure Analysis Population Description: Data are for mothers only (n = 76)
Baseline characteristics by cohort
| Measure |
Clear Bottle Group
n=76 Participants
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.
|
Opaque Bottle Group
n=76 Participants
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).
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.0 months
STANDARD_DEVIATION 1.5 • n=38 Participants • Data are for infants only (n = 76)
|
2.8 months
STANDARD_DEVIATION 1.3 • n=38 Participants • Data are for infants only (n = 76)
|
2.9 months
STANDARD_DEVIATION 1.4 • n=76 Participants • Data are for infants only (n = 76)
|
|
Sex: Female, Male
Female
|
25 Participants
n=38 Participants • Data are for infants only (n = 76)
|
15 Participants
n=38 Participants • Data are for infants only (n = 76)
|
40 Participants
n=76 Participants • Data are for infants only (n = 76)
|
|
Sex: Female, Male
Male
|
13 Participants
n=38 Participants • Data are for infants only (n = 76)
|
23 Participants
n=38 Participants • Data are for infants only (n = 76)
|
36 Participants
n=76 Participants • Data are for infants only (n = 76)
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
10 Participants
n=38 Participants • Data are for infants only (n = 76)
|
8 Participants
n=38 Participants • Data are for infants only (n = 76)
|
18 Participants
n=76 Participants • Data are for infants only (n = 76)
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
26 Participants
n=38 Participants • Data are for infants only (n = 76)
|
29 Participants
n=38 Participants • Data are for infants only (n = 76)
|
55 Participants
n=76 Participants • Data are for infants only (n = 76)
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=38 Participants • Data are for infants only (n = 76)
|
0 Participants
n=38 Participants • Data are for infants only (n = 76)
|
2 Participants
n=76 Participants • Data are for infants only (n = 76)
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=38 Participants • Data are for infants only (n = 76)
|
1 Participants
n=38 Participants • Data are for infants only (n = 76)
|
1 Participants
n=76 Participants • Data are for infants only (n = 76)
|
|
Region of Enrollment
United States
|
76 participants
n=76 Participants
|
76 participants
n=76 Participants
|
152 participants
n=152 Participants
|
PRIMARY outcome
Timeframe: 12-week periodPopulation: 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)
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).
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=30 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=30 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
n=30 Participants
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
n=30 Participants
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
|---|---|---|---|---|
|
Infant Intake (mL) During the Observed Feeding
|
116.7 mL
Standard Error 10.1
|
119.5 mL
Standard Error 10.0
|
107.5 mL
Standard Error 10.2
|
114.9 mL
Standard Error 10.1
|
PRIMARY outcome
Timeframe: 12-week periodPopulation: 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)
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.
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=30 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=30 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
n=30 Participants
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
n=30 Participants
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
|---|---|---|---|---|
|
Maternal Sensitivity to Infant Cues
|
12.3 score on a scale
Standard Error 0.4
|
12.6 score on a scale
Standard Error 0.4
|
12.2 score on a scale
Standard Error 0.4
|
12.2 score on a scale
Standard Error 0.4
|
PRIMARY outcome
Timeframe: 12-week periodPopulation: 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.
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.
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=18 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=17 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
|---|---|---|---|---|
|
Infant Weight-for-length Z-scores
|
0.22 z-score
Standard Error 0.16
|
0.69 z-score
Standard Error 0.15
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-week periodPopulation: 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.
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.
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=14 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=14 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
|---|---|---|---|---|
|
Change in Infant Waist Circumference
|
44.7 centimeters
Standard Error 0.59
|
43.1 centimeters
Standard Error 0.63
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-week periodPopulation: 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.
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.
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=7 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=7 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
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|---|---|---|---|---|
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Change in Infant Triceps Skinfolds z-Scores
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-0.52 z-scores
Standard Error 0.40
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-0.77 z-scores
Standard Error 0.47
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—
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—
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SECONDARY outcome
Timeframe: 12-week periodPopulation: 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.
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.
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=7 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=7 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
|---|---|---|---|---|
|
Change in Infant Subscapular Skinfolds z-Scores
|
0.67 z-scores
Standard Error 0.22
|
0.37 z-scores
Standard Error 0.25
|
—
|
—
|
SECONDARY outcome
Timeframe: 12-week periodPopulation: 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)
Mothers' perceptions of their assigned bottles, including any perceived barriers to their use, were assessed via a questionnaire developed by the investigators.
Outcome measures
| Measure |
Clear Bottle Group - Clear Bottle Condition
n=30 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Clear Bottle Group - Opaque Bottle Condition.
n=30 Participants
The Clear Bottle group was given a set of clear bottles to use during infant feedings for a full 12-week period. 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.
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.
|
Opaque Bottle Group - Clear Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
Opaque Bottle Group - Opaque Bottle Condition
This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. 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).
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.
|
|---|---|---|---|---|
|
Mothers' Perceptions of the Bottles
indicated they would continue to use their assigned bottle after the study ended
|
24 Participants
|
24 Participants
|
—
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—
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Mothers' Perceptions of the Bottles
indicated they would not continue to use their assigned bottle after the study ended
|
6 Participants
|
6 Participants
|
—
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—
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Adverse Events
Clear Bottle Group - Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clear Bottle Group - Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opaque Bottle Group - Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opaque Bottle Group - Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alison Ventura
California Polytechnic State University
Phone: (805) 756-5693
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place