Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if digital photography on a Smartphone and the Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a validation study; there is no hypothesis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | All participants enrolled between November 2012 and March 2013 under the original protocol. | ||
| Cohort 2 | After Cohort 1 was completed, the study investigators changed the protocol to eliminate the photograph/weight of the powdered formula alone in each bottle to reduce burden. All other protocol procedures remained the same. Cohort 2 participants enrolled between April 2013 and May 2014. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles | Kilocalorie (Kcal) Difference in prepared infant formula intake detected in a bottle between the Remote Food Photography Method (RFPM) and direct weighing Kilocalorie difference between the Remote Food Photography Method and direct weighing with all bottles that were prepared included Kilocalorie difference is Remote Food Photography Method - Direct Weighing | Measures will be performed twice about 5-10 days apart |
| Measure | Description | Time Frame |
|---|---|---|
| Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Kilocalorie difference between the Remote Food Photography Method and direct weighing separately analyzed by the four different bottle sizes that were prepared (2 oz bottles only, 4 oz bottles only, 6 oz bottles only, and 8 oz bottles only). Each participant prepared 3 sets of 2 oz bottles, 3 sets of 4 oz bottles, 3 sets of 6 oz bottles, and 3 sets of 8 oz bottles and all bottles of the specified size were included in the analysis. Kilocalorie difference is Remote Food Photography Method - Direct Weighing |
| Measure | Description | Time Frame |
|---|---|---|
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 2 oz prepared bottles only. Each participant prepared 3 sets of 2 oz bottles, and all bottles of the specified size were included in the analysis. |
Inclusion Criteria:
Not provided
Not provided
Not provided
Up to 75 men and women will be recruited to participate in a 2-week pilot study involving infant formula preparation. Participation is open to all adult individuals.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leanne M Redman, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Corby Martin, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
Not provided
| Label | URL |
|---|---|
| PBRC Website description and webscreening link | View source |
Not provided
Not provided
Individuals were recruited through advertisements and targeted emails directed to residents of the Greater Baton Rouge area.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants in Cohort 1 | No intervention, time frame of visit determined Cohort 1 vs Cohort 2 |
| FG001 | Study Participants in Cohort 2 | No intervention, time frame of visit determined Cohort 1 vs Cohort 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adults who were caregivers or non-caregivers of infants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants In Cohort 1 | No intervention- time frame of visits determined Cohort 1 vs Cohort 2 |
| BG001 | Study Participants in Cohort 2 | No intervention- time frame of visits determined Cohort 1 vs Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles | Kilocalorie (Kcal) Difference in prepared infant formula intake detected in a bottle between the Remote Food Photography Method (RFPM) and direct weighing Kilocalorie difference between the Remote Food Photography Method and direct weighing with all bottles that were prepared included Kilocalorie difference is Remote Food Photography Method - Direct Weighing | Since Cohort 2 had a modified protocol where the step involving photographs and direct weights of bottles with powdered formula only was not completed, the kilocalories for all participants in Cohort 2 cannot be determined. Powder not water is the source of kilocalories in formula; we could not accurately determine kilocalories without this step. | Posted | Mean | Standard Deviation | kilocalories | Measures will be performed twice about 5-10 days apart |
|
The study time period was 5-10 days.
In this study, an adverse event or experience is defined as any health-related unfavorable or unintended medical occurrence that happens after screening. We anticipate most adverse events will be mild and the participant will be able to resume activities within a day or two of reporting the event. Adverse Event reporting will follow the requirements of the Pennington Biomedical Research Center Institutional Review Board.
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 | Study Participants in Cohort 1 | No intervention, time frame of visit determined Cohort 1 vs Cohort 2 |
Not provided
Not provided
Without powder alone, kilocalories for all participants in Cohort 2 cannot be determined due to the protocol modification completed prior to Cohort 2. Therefore, primary and secondary outcome results cannot be determined for Cohort 2 participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leanne Redman, PhD | Pennington Biomedical Research Center | 2257630947 | leanne.redman@pbrc.edu |
Not provided
Not provided
Not provided
Not provided
| Measures will be performed twice about 5-10 days apart |
| Measures will be performed twice about 5-10 days apart |
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 4 oz prepared bottles only. Each participant prepared 3 sets of 4 oz bottles, and all bottles of the specified size were included in the analysis. | Measures will be performed twice about 5-10 days apart |
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 6 oz prepared bottles only. Each participant prepared 3 sets of 6 oz bottles, and all bottles of the specified size were included in the analysis. | Measures will be performed twice about 5-10 days apart |
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 8 oz prepared bottles only. Each participant prepared 3 sets of 8 oz bottles, and all bottles of the specified size were included in the analysis. | Measures will be performed twice about 5-10 days apart |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Caregiver Status | Count of Participants | Participants | No |
|
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
| OG001 | Study Participants in Cohort 2 | No intervention, time frame of visit determined Cohort 1 vs Cohort 2 |
|
|
| Secondary | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Kilocalorie difference between the Remote Food Photography Method and direct weighing separately analyzed by the four different bottle sizes that were prepared (2 oz bottles only, 4 oz bottles only, 6 oz bottles only, and 8 oz bottles only). Each participant prepared 3 sets of 2 oz bottles, 3 sets of 4 oz bottles, 3 sets of 6 oz bottles, and 3 sets of 8 oz bottles and all bottles of the specified size were included in the analysis. Kilocalorie difference is Remote Food Photography Method - Direct Weighing | Since Cohort 2 had a modified protocol where the step involving photographs and direct weights of bottles with powdered formula only was not completed, the kilocalories for all participants in Cohort 2 cannot be determined. Powder not water is the source of kilocalories in formula; we could not accurately determine kilocalories without this step. | Posted | Mean | Standard Deviation | kilocalories | Measures will be performed twice about 5-10 days apart |
|
|
|
| Other Pre-specified | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 2 oz prepared bottles only. Each participant prepared 3 sets of 2 oz bottles, and all bottles of the specified size were included in the analysis. | Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers. | Posted | Mean | Standard Deviation | grams | Measures will be performed twice about 5-10 days apart |
|
|
|
| Other Pre-specified | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 4 oz prepared bottles only. Each participant prepared 3 sets of 4 oz bottles, and all bottles of the specified size were included in the analysis. | Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers. | Posted | Mean | Standard Deviation | grams | Measures will be performed twice about 5-10 days apart |
|
|
|
| Other Pre-specified | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 6 oz prepared bottles only. Each participant prepared 3 sets of 6 oz bottles, and all bottles of the specified size were included in the analysis. | Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers. | Posted | Mean | Standard Deviation | grams | Measures will be performed twice about 5-10 days apart |
|
|
|
| Other Pre-specified | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months. Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 8 oz prepared bottles only. Each participant prepared 3 sets of 8 oz bottles, and all bottles of the specified size were included in the analysis. | Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers. | Posted | Mean | Standard Deviation | grams | Measures will be performed twice about 5-10 days apart |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Study Participants in Cohort 2 | No intervention, time frame of visit determined Cohort 1 vs Cohort 2 | 0 | 22 | 0 | 22 | 0 | 22 |
Not provided
Not provided
Not provided
|
| Direct Weighing- 4 oz prepared bottles |
|
| Remote Food Photography-6 oz prepared bottles |
|
| Direct Weighing- 6 oz prepared bottles |
|
| Remote Food Photography-8 oz prepared bottles |
|
| Direct Weighing- 8 oz prepared bottles |
|
| Infant Non-caregivers |
|
|
| Infant Non-caregivers |
|
|
| Infant Non-caregivers |
|
|
| Infant Non-caregivers |
|
|