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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD104028-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of California, Los Angeles | OTHER |
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The purpose of this voluntary research study is to determine if calibrated formula feeding recommendations can promote optimal growth for the first 6 months after birth for mothers with a pre-pregnancy body mass index of 25 or more.
This pilot study seeks to determine if formula feeding recommendations that are calibrated using age and weight specific caloric intake recommendations can prevent excessive infant weight gain and reduce overweight in the first 6 months after birth among infants born to mothers with overweight prior to pregnancy electing to exclusively formula feed their infants. Calibrated formula feeding refers to adjusting the recommended daily caloric formula intake to account for weight status. A cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care. Intervention group parents will also be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. The investigators hypothesize that the calibrated formula intake intervention will reduce rapid infant gain and overweight during infancy resulting in lower weight-for-length at age 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria |
|
| Control | No Intervention | The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Provided with educational materials, guidelines and instructions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conditional Weight Gain Difference Between Study Groups | Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at birth, with length for age at birth and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values. | Between birth and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Conditional Weight Gain Difference Between Study Groups | Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at 1 month, with length for age at 1 month and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Paul, MD, MSc | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
This may change in the future depending on results, although all individual participant data will be de-identified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria |
| FG001 | Control | The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Conditional Weight Gain Difference Between Study Groups | Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at birth, with length for age at birth and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values. | Posted | Mean | 95% Confidence Interval | Conditional Weight Gain score | Between birth and 6 months |
|
6 months
Growth faltering defined as either:
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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 | Intervention | The intervention arm is characterized by calibrated formula feeding recommendations. The intervention group parents will be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. N=30 meeting inclusion/exclusion criteria |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Growth Faltering | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Paul, MD | Penn State College of Medicine | 7175318006 | ipaul@pennstatehealth.psu.edu |
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| 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 29, 2021 | Apr 5, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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A cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care.
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| During the intervention period spanning Ages 1-6 Months |
| Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards | Weight-for-Length Z-score is based on values from the World Health Organization Growth Standards. A z-score of 0 represents the population mean. Positive values represent values above the population mean. Negative values represent values below the population mean | 1 time point at age 6 Months |
| Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period | repeated measures analysis of weight-for-length | Spanning ages 1-6 months |
| Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) | % overweight by study group | 1 time point at age 6 months |
| BG001 |
| Control |
The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| OG001 | Control | Usual care |
|
|
| Secondary | Conditional Weight Gain Difference Between Study Groups | Conditional weight gain is calculated as standardized residuals from the linear regression of weight for age at 6 months on weight for age at 1 month, with length for age at 1 month and 6 months and infant age at the 6-month visit entered as covariates. Note that there are no units for conditional weight gain. The CWG score represents the variation in child weight gain not explained by child age, birth length, or birth weight. A CWG score of zero represents the population mean. Positive CWG scores (above the estimated regression) indicate more rapid or faster than average weight gain, while negative scores (below the estimated regression) indicate slower weight gain. There are no maximum values. | Posted | Mean | 95% Confidence Interval | Conditional weight gain score | During the intervention period spanning Ages 1-6 Months |
|
|
|
| Secondary | Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards | Weight-for-Length Z-score is based on values from the World Health Organization Growth Standards. A z-score of 0 represents the population mean. Positive values represent values above the population mean. Negative values represent values below the population mean | Posted | Mean | 95% Confidence Interval | Z-score | 1 time point at age 6 Months |
|
|
|
| Secondary | Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period | repeated measures analysis of weight-for-length | Posted | Mean | 95% Confidence Interval | kg/m | Spanning ages 1-6 months |
|
|
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| Secondary | Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards) | % overweight by study group | Posted | Count of Participants | Participants | 1 time point at age 6 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 12 |
| 29 |
| EG001 | Control | The control arm will have ad lib feeds as per usual care. N=30 meeting inclusion/exclusion criteria | 0 | 31 | 0 | 31 | 13 | 31 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |