Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21HD096236 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opaque Bottle Group | Experimental | This group was given a set of opaque bottles to use during infant feedings for a full 12-week period. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear Bottle | Other | These mothers received usual care from their pediatric providers and each mother was given 12 conventional, clear bottles of various sizes (4-12 ounces) that were compatible with a variety of different nipples manufactured by leading bottle companies. Mothers were also given handouts about proper formula preparation and paced bottle-feeding, which included messages about feeding in response to infant cues. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Intake (mL) During the Observed Feeding | During post-tests, participants in both the Clear Bottle and Opaque Bottle Groups were asked to use the clear bottle during one feeding observation and the opaque bottle during the other feeding across the two post-test assessments, which ensured research assistants remained masked to whether the participant was in the intervention or control group and allowed for within-subject comparison of effects of clear versus opaque bottles on maternal sensitivity and infant intake; order of bottle presentation was counterbalanced. For both opaque and clear bottle-feedings, infant intake was assessed by weighing the infant's bottle before and after each feeding observation using a top-loading balance (SP601 Scout Pro Portable Balance, Ohaus, New Jersey, USA). | 12-week period |
| Maternal Sensitivity to Infant Cues | Mothers' behavior during feeding observations was coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The present analysis focused on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues. | 12-week period |
| Infant Weight-for-length Z-scores | Infants' weight and length were assessed during home-based assessments. Infant weight and length were measured in triplicate using a portable infant scale/infantometer. To minimize bias, infants were always weighed and measured while only wearing a clean diaper and prior to the observed feeding. Weight and length values were standardized to age- and sex-specific weight-for-length z-scores based on the World Health Organization Child Growth Standards (https://www.who.int/tools/child-growth-standards). A z-score of 0 indicates that the child's weight status is at the population median; standard deviations closer to 0 represent healthier weight status. Standard deviations below 0 indicate the child's weight status is below the median, with values < -2 indicating the child is underweight. Standard deviations above 0 indicate the child's weight status is above the median, with values > 2 indicating the child is overweight or obese. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infant Waist Circumference | Infant central adiposity was assessed via a waist circumference measurement, which was assessed during home-based assessments by trained research assistants. Waist circumference was assessed in triplicate using a study-specific Gulick II tape measure. | 12-week period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison K Ventura, PhD | California Polytechnic State University-San Luis Obispo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion | San Luis Obispo | California | 93401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25445988 | Background | 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. | |
| 30345622 | Background | 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. |
Not provided
Not provided
We do not currently plan to make individual participant data available to other researchers.
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
38 mother-infant dyads (38 mothers+38 infants=76 participants total) were in the Clear Bottle Group and 38 mother-infant dyads (38 mothers+38 infants=76 participants total) were in the Opaque Bottle Group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mother Age at Study Entry | Measure Analysis Population Description: Data are for mothers only (n = 76) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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) | Posted | Least Squares Mean | Standard Error | mL | 12-week period |
3-5 months after randomization
Definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clear Bottle Group - Mothers | This 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. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Ventura | California Polytechnic State University | (805) 756-5693 | akventur@calpoly.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 5, 2018 | Oct 14, 2018 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
The video coders were masked during video analysis.
|
| Opaque Bottle | Other | These mothers received everything provided to the clear group, but instead received 12 opaque bottles of various sizes (4-12 ounces). These bottles were stainless steel and compatible with a variety of different nipples manufactured by a leading bottle company. Mothers in the intervention group also received an additional handout that contained safety tips for their opaque bottles (e.g., never microwave your bottle). |
|
| 12-week period |
| Change in Infant Triceps Skinfolds z-Scores |
Triceps skinfold thickness, a marker of infant adiposity, was assessed during home-based assessments by trained research assistants. A study-specific Harpenden caliper was used for this assessment. Triceps skinfold thickness values were standardized to age- and sex-specific z-scores based on the World Health Organization Child Growth Standards (https://www.who.int/tools/child-growth-standards). A z-score of 0 indicates that the child's adiposity is at the population median. Standard deviations below 0 indicate the child's adiposity is below the median and standard deviations above 0 indicate the child's adiposity is above the median. Standard deviations closer to 0 represent healthier levels of adiposity. |
| 12-week period |
| Change in Infant Subscapular Skinfolds z-Scores | Subscapular skinfold thickness, a marker of infant adiposity, was assessed during home-based assessments by trained research assistants. A study-specific Harpenden caliper was used for this assessment. Subscapular skinfold thickness values were standardized to age- and sex-specific z-scores based on the World Health Organization Child Growth Standards (https://www.who.int/tools/child-growth-standards). A z-score of 0 indicates that the child's adiposity is at the population median. Standard deviations below 0 indicate the child's adiposity is below the median and standard deviations above 0 indicate the child's adiposity is above the median. Standard deviations closer to 0 represent healthier levels of adiposity. | 12-week period |
| Mothers' Perceptions of the Bottles | Mothers' perceptions of their assigned bottles, including any perceived barriers to their use, were assessed via a questionnaire developed by the investigators. | 12-week period |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Infant Age at Study Entry | Data are for infants only (n = 76) | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Mothers' sex; self-reported | Data are for mothers only (n = 76) | Count of Participants | Participants |
|
| Sex: Female, Male | Infant sex; reported by mothers | Data are for infants only (n = 76) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Maternal race/ethnicity was self-reported | Data are for mothers only (n = 76) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Infant race/ethnicity was reported by mothers | Data are for infants only (n = 76) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Clear Bottle Group - Clear Bottle Condition | 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. |
| OG001 | Clear Bottle Group - Opaque Bottle Condition. | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| 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. | 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) | Posted | Least Squares Mean | Standard Error | score on a scale | 12-week period |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | z-score | 12-week period |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | centimeters | 12-week period |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | z-scores | 12-week period |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | z-scores | 12-week period |
|
|
|
| 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. | 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) | Posted | Count of Participants | Participants | 12-week period |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Clear Bottle Group - Infants | This 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. | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | Opaque Bottle Group - Mothers | 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). | 0 | 38 | 0 | 38 | 0 | 38 |
| EG003 | Opaque Bottle Group - Infants | 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). | 0 | 38 | 0 | 38 | 0 | 38 |
Not provided
Not provided
| Asian |
|
| Other |
|
| Asian |
|
| Other |
|