Estimating Infant Food Intake
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 18 years of age * Willing to complete 2 study visits at Pennington Biomedical (PBRC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles | Measures will be performed twice about 5-10 days apart | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Measures will be performed twice about 5-10 days apart | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | Measures will be performed twice about 5-10 days apart | 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. |
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | Measures will be performed twice about 5-10 days apart | 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. |
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | Measures will be performed twice about 5-10 days apart | 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. |
| Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | Measures will be performed twice about 5-10 days apart | 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. |
Countries
United States
Participant flow
Recruitment details
Individuals were recruited through advertisements and targeted emails directed to residents of the Greater Baton Rouge area.
Participants by arm
| Arm | Count |
|---|---|
| Study Participants In Cohort 1 No intervention- time frame of visits determined Cohort 1 vs Cohort 2 | 53 |
| Study Participants in Cohort 2 No intervention- time frame of visits determined Cohort 1 vs Cohort 2 | 22 |
| Total | 75 |
Baseline characteristics
| Characteristic | Study Participants in Cohort 2 | Total | Study Participants In Cohort 1 |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 11.9 | 32.7 years STANDARD_DEVIATION 13.2 | 32.6 years STANDARD_DEVIATION 13.8 |
| Caregiver Status Caregiver of Infant | 14 Participants | 42 Participants | 28 Participants |
| Caregiver Status Non-caregiver of Infant | 8 Participants | 33 Participants | 25 Participants |
| Region of Enrollment United States | 22 participants | 75 participants | 53 participants |
| Sex: Female, Male Female | 20 Participants | 67 Participants | 47 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 22 |
| other Total, other adverse events | 0 / 53 | 0 / 22 |
| serious Total, serious adverse events | 0 / 53 | 0 / 22 |
Outcome results
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
Time frame: Measures will be performed twice about 5-10 days apart
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles | Remote Food Photography Method | 82.1 kilocalories | Standard Deviation 42.3 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles | Direct Weighing | 85.3 kilocalories | Standard Deviation 43.2 |
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
Time frame: Measures will be performed twice about 5-10 days apart
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Direct Weighing- 6 oz prepared bottles | 101.1 kilocalories | Standard Deviation 25.3 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Remote Food Photography-2 oz prepared bottles | 34.2 kilocalories | Standard Deviation 7.8 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Direct Weighing- 2 oz prepared bottles | 35.8 kilocalories | Standard Deviation 7.6 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Remote Food Photography-4 oz prepared bottles | 64.5 kilocalories | Standard Deviation 13.8 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Direct Weighing- 4 oz prepared bottles | 69.3 kilocalories | Standard Deviation 16.8 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Remote Food Photography-6 oz prepared bottles | 94.9 kilocalories | Standard Deviation 22.4 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Remote Food Photography-8 oz prepared bottles | 135.0 kilocalories | Standard Deviation 28.6 |
| Study Participants in Cohort 1 | Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Direct Weighing- 8 oz prepared bottles | 134.9 kilocalories | Standard Deviation 32.8 |
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.
Time frame: Measures will be performed twice about 5-10 days apart
Population: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | Infant Caregivers | 57.5 grams | Standard Deviation 8 |
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | Infant Non-caregivers | 57.8 grams | Standard Deviation 7.6 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | Infant Caregivers | 64.2 grams | Standard Deviation 6.7 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only | Infant Non-caregivers | 58.9 grams | Standard Deviation 11.5 |
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.
Time frame: Measures will be performed twice about 5-10 days apart
Population: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | Infant Caregivers | 115.0 grams | Standard Deviation 16.2 |
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | Infant Non-caregivers | 115.4 grams | Standard Deviation 16.7 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | Infant Caregivers | 128.6 grams | Standard Deviation 13.7 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only | Infant Non-caregivers | 111.7 grams | Standard Deviation 16.6 |
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.
Time frame: Measures will be performed twice about 5-10 days apart
Population: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | Infant Caregivers | 176.6 grams | Standard Deviation 34.8 |
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | Infant Non-caregivers | 180.7 grams | Standard Deviation 36.1 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | Infant Caregivers | 195.0 grams | Standard Deviation 19.5 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only | Infant Non-caregivers | 166.9 grams | Standard Deviation 25.9 |
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.
Time frame: Measures will be performed twice about 5-10 days apart
Population: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | Infant Caregivers | 244.3 grams | Standard Deviation 46.3 |
| Study Participants in Cohort 1 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | Infant Non-caregivers | 243.8 grams | Standard Deviation 37.9 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | Infant Caregivers | 249.3 grams | Standard Deviation 24.1 |
| Study Participants in Cohort 2 | Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only | Infant Non-caregivers | 222.8 grams | Standard Deviation 27.9 |