Trial Outcomes & Findings for Learning to Love Mealtime Together (NCT NCT04502979)
NCT ID: NCT04502979
Last Updated: 2020-09-11
Results Overview
The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
6 Months Post-Baseline (T3)
Results posted on
2020-09-11
Participant Flow
Participant milestones
| Measure |
Responsive Feeding
Intervention families will receive approximately 4 hours of American Sign Language (ASL) and development-specific content related to language and feeding during home visits and phone calls. The initial in-home session with families focused on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs are left with families at the end of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes \[many vegetables\], and appropriate portion sizes and variety for healthy growth.
|
Routine Care
No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
34
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Responsive Feeding
Intervention families will receive approximately 4 hours of American Sign Language (ASL) and development-specific content related to language and feeding during home visits and phone calls. The initial in-home session with families focused on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs are left with families at the end of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes \[many vegetables\], and appropriate portion sizes and variety for healthy growth.
|
Routine Care
No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Learning to Love Mealtime Together
Baseline characteristics by cohort
| Measure |
Responsive Feeding
n=37 Participants
Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes \[many vegetables\], and appropriate portion sizes and variety for healthy growth.
|
Routine Care
n=34 Participants
No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.86 months
STANDARD_DEVIATION 1.57 • n=5 Participants
|
7.29 months
STANDARD_DEVIATION 1.64 • n=7 Participants
|
7.07 months
STANDARD_DEVIATION 1.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 Months Post-Baseline (T3)Population: Measurement error resulted in improbable length data (length recorded as shorter than length at prior visit when infant was younger) for 10 infants total (Responsive Feeding n = 6; Routine Care n = 4). Data for these 10 infants were excluded from analysis at T3.
The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.
Outcome measures
| Measure |
Responsive Feeding
n=28 Participants
Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes \[many vegetables\], and appropriate portion sizes and variety for healthy growth.
|
Routine Care
n=26 Participants
No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
|
|---|---|---|
|
Infant Weight-for-Length Z Scores
|
0.43 z-score
Standard Error 0.15
|
0.12 z-score
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 6 Months Post-Baseline (T3)Population: All data reported were included (missing for 13 infants).
Group mean of Kcal difference between dietary recall (mean of total Kcal from 2-day 24-hour recalls calculated in the Nutrition Data System for Research (NDS-R)) and age-and-sex-specific estimated energy requirements. Lower values represent greater precision of intake.
Outcome measures
| Measure |
Responsive Feeding
n=32 Participants
Intervention families will receive approximately 4 hours of ASL and development specific content related to language and feeding during home visits and phone calls. The initial in-home session with families will focus on teaching ASL signs indicative of hunger, thirst, and satiety. A video and placemat of mealtime signs will be left with families at the completion of the first visit. The remaining sessions, in-home over the next 3 months and by phone monthly thereafter for 6 months total, will focus on reinforcing ASL signing in addition to focused education on particular aspects of language development (receptive language preceding expressive language and increasing intentional communication), feeding development (such as hunger and fullness cues, fear of new foods, the importance of repeated food exposures, variations in intake from meal-to-meal, and the propensity to reject bitter tastes \[many vegetables\], and appropriate portion sizes and variety for healthy growth.
|
Routine Care
n=26 Participants
No intervention is provided to the families in this group; however, portions of the intervention lessons will be made available after completion of data collection.
|
|---|---|---|
|
Mean Infant Caloric Intake Compared to Estimated Energy Requirements
|
120.90 Kcal
Standard Error 43.37
|
242.06 Kcal
Standard Error 48.73
|
Adverse Events
Responsive Feeding
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eric A Hodges, PhD, FNC-BC, FAAN
University of North Carolina at Chapel Hill
Phone: 919-966-0534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place