Feeding Behavior, Infant Obesity, Parenting
Conditions
Keywords
Infant Obesity, Parenting, Feeding Behavior, Responsive Feeding
Brief summary
Infancy is an important target period for obesity prevention because once obese as an infant, the relative risk of remaining obese appears to rise with increasing age at great cost to both individuals and society. The ability to self-regulate energy intake (eating when hungry and stopping when full) is vital to obesity prevention and it is thought that this ability can be derailed by a chronic mismatch between parental feeding behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond fullness). The study will test a novel intervention to help parents and pre-verbal infants better understand one another during feeding and it will offer new insight into how self-regulation of energy intake develops during infancy.
Detailed description
Once obese as an infant, the relative risk of remaining obese appears to rise with increasing age. Thus, the early years of life have been posited as an important target period for obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental factors, obesity fundamentally reflects an imbalance between energy intake and expenditure. Self-regulation of energy intake aligned with physiologic need is essential to this balance. The process(es) by which infants begin to disassociate eating behavior from physiologic need is unclear, thus it is crucial to better understand predictors of individual differences in self-regulation of energy intake. It is well established that autonomic regulation may support infant behavioral regulation, suggesting that autonomic function may be a critical area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction quality during infancy, and findings reveal that more responsive interactions are associated with more effective autonomic regulation. A chronic mismatch between a caregiver's feeding behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond fullness), is thought to contribute to obesity by undermining the infant's capacity to self-regulate intake; the current proposal will be the first to examine the effects on autonomic regulation. The investigators propose an intervention to enrich the capacity of mother-infant dyads to perform their respective interactive tasks. The investigators plan to teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety, which they will in turn teach their preverbal infant. This training in ASL will be augmented with targeted information for mothers about infants' capacities to self-regulate energy intake in response to hunger and satiety and communicate those states with intention. Mothers also will be taught about expected development of infants' eating behaviors and nutritional requirements to support healthy growth. Using a two-group randomized repeated measures design, this study aims to 1) evaluate the feasibility and acceptability of the intervention and study methods, including recruitment, enrollment, and data collection (self-report, anthropometrics, video observations, and respiratory sinus arrhythmia \[RSA\]) for infants and their mothers; 2) evaluate the initial impact of the intervention on observed feeding interactions, reported infant feeding behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth; and, 3) explore preliminary data on concordance between dyadic feeding interactions and autonomic regulation in both mothers and infants (RSA). In addition to a variety of self-report and anthropometric measures, this study will use integrated behavioral (video) and physiologic (RSA) measures to better understand feeding dynamics and their relationship with obesity risk. Understanding these processes is essential for developing appropriate preventions, or interventions, that will help reduce the prevalence of early childhood obesity and its extension into later childhood and beyond. Study Phases: Screening: screening for eligibility and obtaining consent Study Treatment: study intervention/experimental treatment from baseline visit (\[Time 1 (T1)\]: age 4-9-months) monthly until 3-months post-baseline (\[Time 2 (T2)\]: age 7-12-months) Follow-up: 6-months post-baseline (\[Time 3 (T3)\]: age 10-15-months)
Interventions
BEHAVIORALResponsive Feeding Training
Families will receive 4 monthly 1-hour sessions: (1) Signing with infants; (2) infant communication and responsive feeding; (3) nutrition, portion sizes, and neophobia; and, (4) infant intentionality.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 9 Months
Healthy volunteers
No
Inclusion criteria
Parent Inclusion: * Must be able to read, understand, and speak English or Spanish and be willing to be randomized and participate in data collection. * Those who are randomized into the experimental group must also be willing to learn ASL specific to communication of hunger, thirst, and fullness. Infant Inclusion: * Aged at least 3 months at the time of recruitment
Exclusion criteria
Parent Exclusion: * \> 50 years of age Infant Exclusion: * Aged more than 9 months at the time of recruitment * born more than 6 weeks earlier than their estimated due date, * have any developmental delays or disabilities that make it difficult for them to eat, drink, or communicate, * attend regular daycare, * will be younger than 4 months or older than 9 months at the time of the first ASL training.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Weight-for-Length Z Scores | 6 Months Post-Baseline (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Infant Caloric Intake Compared to Estimated Energy Requirements | 6 Months Post-Baseline (T3) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Responsive Feeding 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. | 37 |
| 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. | 34 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 37 Participants | 34 Participants | 71 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.86 months STANDARD_DEVIATION 1.57 | 7.29 months STANDARD_DEVIATION 1.64 | 7.07 months STANDARD_DEVIATION 1.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 31 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 20 Participants | 43 Participants |
| Region of Enrollment United States | 37 Participants | 34 Participants | 71 Participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 34 Participants |
| Sex: Female, Male Male | 22 Participants | 15 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 34 |
| other Total, other adverse events | 0 / 37 | 0 / 34 |
| serious Total, serious adverse events | 0 / 37 | 0 / 34 |
Outcome results
Primary
Infant Weight-for-Length Z Scores
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Responsive Feeding | Infant Weight-for-Length Z Scores | 0.43 z-score | Standard Error 0.15 |
| Routine Care | Infant Weight-for-Length Z Scores | 0.12 z-score | Standard Error 0.15 |
p-value: 0.0795% CI: [-0.11, 0.73]Mixed Models Analysis
Secondary
Mean Infant Caloric Intake Compared to Estimated Energy Requirements
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.
Time frame: 6 Months Post-Baseline (T3)
Population: All data reported were included (missing for 13 infants).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Responsive Feeding | Mean Infant Caloric Intake Compared to Estimated Energy Requirements | 120.90 Kcal | Standard Error 43.37 |
| Routine Care | Mean Infant Caloric Intake Compared to Estimated Energy Requirements | 242.06 Kcal | Standard Error 48.73 |
p-value: 0.0495% CI: [-252.73, 10.41]Mixed Models Analysis