Trial Outcomes & Findings for Remote Food Photography Method in Infants (NCT NCT01762631)
NCT ID: NCT01762631
Last Updated: 2021-09-16
Results Overview
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
COMPLETED
75 participants
Measures will be performed twice about 5-10 days apart
2021-09-16
Participant Flow
Individuals were recruited through advertisements and targeted emails directed to residents of the Greater Baton Rouge area.
Participant milestones
| Measure |
Study Participants in Cohort 1
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
22
|
|
Overall Study
COMPLETED
|
53
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remote Food Photography Method in Infants
Baseline characteristics by cohort
| Measure |
Study Participants In Cohort 1
n=53 Participants
No intervention- time frame of visits determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
n=22 Participants
No intervention- time frame of visits determined Cohort 1 vs Cohort 2
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
22 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Caregiver Status
Caregiver of Infant
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Caregiver Status
Non-caregiver of Infant
|
25 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measures will be performed twice about 5-10 days apartPopulation: 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.
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
Outcome measures
| Measure |
Study Participants in Cohort 1
n=53 Participants
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
|---|---|---|
|
Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles
Remote Food Photography Method
|
82.1 kilocalories
Standard Deviation 42.3
|
—
|
|
Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles
Direct Weighing
|
85.3 kilocalories
Standard Deviation 43.2
|
—
|
SECONDARY outcome
Timeframe: Measures will be performed twice about 5-10 days apartPopulation: 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.
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
Outcome measures
| Measure |
Study Participants in Cohort 1
n=53 Participants
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
|---|---|---|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Remote Food Photography-2 oz prepared bottles
|
34.2 kilocalories
Standard Deviation 7.8
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Direct Weighing- 2 oz prepared bottles
|
35.8 kilocalories
Standard Deviation 7.6
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Remote Food Photography-4 oz prepared bottles
|
64.5 kilocalories
Standard Deviation 13.8
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Direct Weighing- 4 oz prepared bottles
|
69.3 kilocalories
Standard Deviation 16.8
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Remote Food Photography-6 oz prepared bottles
|
94.9 kilocalories
Standard Deviation 22.4
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Direct Weighing- 6 oz prepared bottles
|
101.1 kilocalories
Standard Deviation 25.3
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Remote Food Photography-8 oz prepared bottles
|
135.0 kilocalories
Standard Deviation 28.6
|
—
|
|
Kilocalorie (Kcal) Difference Between Different Bottle Sizes
Direct Weighing- 8 oz prepared bottles
|
134.9 kilocalories
Standard Deviation 32.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measures will be performed twice about 5-10 days apartPopulation: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
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.
Outcome measures
| Measure |
Study Participants in Cohort 1
n=53 Participants
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
n=22 Participants
No intervention, time frame of visit determined Cohort 1 vs 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
|
57.8 grams
Standard Deviation 7.6
|
58.9 grams
Standard Deviation 11.5
|
|
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 8.0
|
64.2 grams
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measures will be performed twice about 5-10 days apartPopulation: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
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.
Outcome measures
| Measure |
Study Participants in Cohort 1
n=53 Participants
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
n=22 Participants
No intervention, time frame of visit determined Cohort 1 vs 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
|
115.0 grams
Standard Deviation 16.2
|
128.6 grams
Standard Deviation 13.7
|
|
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
|
111.7 grams
Standard Deviation 16.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measures will be performed twice about 5-10 days apartPopulation: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
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.
Outcome measures
| Measure |
Study Participants in Cohort 1
n=53 Participants
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
n=22 Participants
No intervention, time frame of visit determined Cohort 1 vs 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
|
176.6 grams
Standard Deviation 34.8
|
195.0 grams
Standard Deviation 19.5
|
|
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
|
166.9 grams
Standard Deviation 25.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measures will be performed twice about 5-10 days apartPopulation: Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.
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.
Outcome measures
| Measure |
Study Participants in Cohort 1
n=53 Participants
No intervention, time frame of visit determined Cohort 1 vs Cohort 2
|
Study Participants in Cohort 2
n=22 Participants
No intervention, time frame of visit determined Cohort 1 vs 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
|
244.3 grams
Standard Deviation 46.3
|
249.3 grams
Standard Deviation 24.1
|
|
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
|
222.8 grams
Standard Deviation 27.9
|
Adverse Events
Study Participants in Cohort 1
Study Participants in Cohort 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place