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| Name | Class |
|---|---|
| Center for Children's Healthy Lifestyles & Nutrition | UNKNOWN |
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The purpose of this study is to learn if there is a relationship between added sugar intake during pregnancy, infancy, and toddlerhood and the brain's structure and function at 5-6 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADORE GAINS Participants | Children's who participated in the ADORE GAINS study were invited to participate as their body composition and dietary intake was collected during their infancy and toddlerhood. |
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| Measure | Description | Time Frame |
|---|---|---|
| Added Sugars Intake Relationship to Brain Structure | Assess the impact of added sugars intake measured by 24-hour dietary intake on brain structure, quantified as brain volume, via an MRI 3D MPRAGE and fMRI sequencing. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
| Added Sugars Intake Relationship to Brain Function | Assess the impact of added sugars intake measured by 24-hour dietary intake on the brain's function via EEG (task-based (Go/NoGo task) event-related potentials (ERPs)) to identify brain activity related to inhibitory control, quantified by amplitude for the Go and NoGo conditions. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
| Fructose Intake Relationship to Brain Structure | Assess the impact of fructose intake measured by 24-hour dietary intake on brain structure, quantified as brain volume, via an MRI 3D MPRAGE and fMRI sequencing. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
| Measure | Description | Time Frame |
|---|---|---|
| Added Sugars Intake Relationship to Cognition Specifically Attention Development | Assess the impact of added sugars intake measured by 24-hour dietary intake on cognition via a Dimensional Change Card Sort (DCCS) task measuring attention development. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants received an invitation to participate in this study if they were enrolled in the ADORE GAINS study as an infant and toddler.
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| Name | Affiliation | Role |
|---|---|---|
| Holly Hull, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADORE GAINS Participants | Children's who participated in the ADORE GAINS study were invited to participate as their body composition and dietary intake was collected during their infancy and toddlerhood. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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42 participants enrolled, two participants did not complete the study
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| ID | Title | Description |
|---|---|---|
| BG000 | ADORE GAINS Participants | Children's who participated in the ADORE GAINS study were invited to participate as their body composition and dietary intake was collected during their infancy and toddlerhood. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Added Sugars Intake Relationship to Brain Structure | Assess the impact of added sugars intake measured by 24-hour dietary intake on brain structure, quantified as brain volume, via an MRI 3D MPRAGE and fMRI sequencing. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | only 13 participants had complete/valid dietary data and usable MRI data | Posted | Number | Pearson correlation coefficient | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
|
Collected for the duration of study visits, an average of 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADORE GAINS Participants | Children's who participated in the ADORE GAINS study were invited to participate as their body composition and dietary intake was collected during their infancy and toddlerhood. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Hull | The University of Kansas Medical Center | 9135881000 | hhull@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2024 | May 22, 2025 | Prot_SAP_000.pdf |
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| Fructose Intake Relationship to Brain Function | Assess the impact of fructose intake measured by 24-hour dietary intake on the brain's function via EEG (task-based (Go/NoGo task) event-related potentials (ERPs)) to identify brain activity related to inhibitory control, quantified by amplitude for the Go and NoGo conditions. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
| Day 7 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
| Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness | Assess the impact of added sugars intake measured by 24-hour dietary intake on cognition via Peabody Picture Vocabulary Test measuring vocabulary receptiveness. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | Day 7 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Percent of energy (kilocalories) from added sugars at age 5-6 years | two participants had incomplete/invalid dietary data | Mean | Standard Deviation | Percentage of kilocalorie intake |
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| Percent of energy (kilocalories) from fructose at age 5-6 years | two participants had incomplete/invalid dietary data | Mean | Standard Deviation | Percentage of kilocalorie intake |
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|
|
| Primary | Added Sugars Intake Relationship to Brain Function | Assess the impact of added sugars intake measured by 24-hour dietary intake on the brain's function via EEG (task-based (Go/NoGo task) event-related potentials (ERPs)) to identify brain activity related to inhibitory control, quantified by amplitude for the Go and NoGo conditions. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | only 18 participants had both complete/valid dietary data and EEG data | Posted | Number | Pearson correlation coefficient | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
|
|
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| Primary | Fructose Intake Relationship to Brain Structure | Assess the impact of fructose intake measured by 24-hour dietary intake on brain structure, quantified as brain volume, via an MRI 3D MPRAGE and fMRI sequencing. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | only 13 participants had complete/valid dietary data and usable MRI data | Posted | Number | Pearson correlation coefficient | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
|
|
|
| Primary | Fructose Intake Relationship to Brain Function | Assess the impact of fructose intake measured by 24-hour dietary intake on the brain's function via EEG (task-based (Go/NoGo task) event-related potentials (ERPs)) to identify brain activity related to inhibitory control, quantified by amplitude for the Go and NoGo conditions. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | only 18 participants had both complete/valid dietary data and EEG data | Posted | Number | Pearson correlation coefficient | Day 1 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
|
|
|
| Secondary | Added Sugars Intake Relationship to Cognition Specifically Attention Development | Assess the impact of added sugars intake measured by 24-hour dietary intake on cognition via a Dimensional Change Card Sort (DCCS) task measuring attention development. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | three participants either had incomplete/invalid dietary data and/or did not complete the cognitive test | Posted | Number | Pearson correlation coefficient | Day 7 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
|
|
|
| Secondary | Added Sugars Intake Relationship to Cognition Specifically Vocabulary Receptiveness | Assess the impact of added sugars intake measured by 24-hour dietary intake on cognition via Peabody Picture Vocabulary Test measuring vocabulary receptiveness. Maternal dietary intake information was collected at baseline in the ADORE study between 12-20 weeks gestation. Offspring dietary intake information was collected at 6-months, 12-months, and 24-months of age in the ADORE GAINS study. Dietary intake, MRI, EEG, and cognition were assessed at age 5-6 years in the present study. | three participants either had incomplete/invalid dietary data and/or did not complete the cognitive test | Posted | Number | Pearson correlation coefficient | Day 7 in the present study (age 5-6 years old); Baseline, 6 months, 12 months and 24 months in the ADORE GAINS study; Baseline (12-20 weeks gestation) in the ADORE study; |
|
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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| No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 5-6 years |
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| Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 6 months |
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| No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 6 months |
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| Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 6 months |
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| No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 6 months |
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| Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 12 months |
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| No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 12 months |
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| Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 12 months |
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| No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 12 months |
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| Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 24 months |
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| No-Go Trials N2 Amplitude and Percent of Calories from Added Sugars at age 24 months |
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| Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 24 months |
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| No-Go Trials P3 Amplitude and Percent of Calories from Added Sugars at age 24 months |
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| Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars |
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| No-Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars |
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| Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars |
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| No-Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Added Sugars |
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| Right Hippocampal Volume and Percent of Calories from Fructose at age 6 months |
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| Left Hippocampal Volume and Percent of Calories from Fructose at age 12 months |
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| Right Hippocampal Volume and Percent of Calories from Fructose at age 12 months |
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| Left Hippocampal Volume and Percent of Calories from Fructose at age 24 months |
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| Right Hippocampal Volume and Percent of Calories from Fructose at age 24 months |
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| Left Hippocampal Volume and Maternal Prenatal Percent of Calories from Fructose |
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| Right Hippocampal Volume and Maternal Prenatal Percent of Calories from Fructose |
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| No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 5-6 years |
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| Go Trials N2 Amplitude and Percent of Calories from Fructose at age 6 months |
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| No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 6 months |
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| Go Trials P3 Amplitude and Percent of Calories from Fructose at age 6 months |
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| No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 6 months |
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| Go Trials N2 Amplitude and Percent of Calories from Fructose at age 12 months |
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| No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 12 months |
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| Go Trials P3 Amplitude and Percent of Calories from Fructose at age 12 months |
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| No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 12 months |
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| Go Trials N2 Amplitude and Percent of Calories from Fructose at age 24 months |
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| No-Go Trials N2 Amplitude and Percent of Calories from Fructose at age 24 months |
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| Go Trials P3 Amplitude and Percent of Calories from Fructose at age 24 months |
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| No-Go Trials P3 Amplitude and Percent of Calories from Fructose at age 24 months |
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| Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Fructose |
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| No-Go Trials N2 Amplitude and Maternal Prenatal Percent of Calories from Fructose |
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| Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Fructose |
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| No-Go Trials P3 Amplitude and Maternal Prenatal Percent of Calories from Fructose |
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| DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 6 months |
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| DCCS Borders Score and Percent of Calories from Added Sugars at age 6 months |
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| DCCS Pre-Switch Score and Percent of Calories from Added Sugars at age 12 months |
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| DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 12 months |
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| DCCS Borders Score and Percent of Calories from Added Sugars at age 12 months |
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| DCCS Pre-Switch Score and Percent of Calories from Added Sugars at age 24 months |
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| DCCS Post-Switch Score and Percent of Calories from Added Sugars at age 24 months |
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| DCCS Borders Score and Percent of Calories from Added Sugars at age 24 months |
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| DCCS Pre-Switch Score and Maternal Prenatal Percent of Calories from Added Sugars |
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| DCCS Post-Switch Score and Maternal Prenatal Percent of Calories from Added Sugars |
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| DCCS Borders Score and Maternal Prenatal Percent of Calories from Added Sugars |
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| PPVT Percentile and Percent of Calories from Added Sugars at age 6 months |
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| PPVT Standard Score and Percent of Calories from Added Sugars at age 12 months |
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| PPVT Percentile and Percent of Calories from Added Sugars at age 12 months |
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| PPVT Standard Score and Percent of Calories from Added Sugars at age 24 months |
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| PPVT Percentile and Percent of Calories from Added Sugars at age 24 months |
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| PPVT Standard Score and Maternal Prenatal Percent of Calories from Added Sugars |
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| PPVT Percentile and Maternal Prenatal Percent of Calories from Added Sugars |
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