An interventional study of Responsive Feeding Training in Infant Obesity, Parenting and Feeding Behavior, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 3 Months to 9 Months. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
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)
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 71 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
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Parent Inclusion:
Infant Inclusion:
Exclusion Criteria:
Parent Exclusion:
Infant Exclusion:
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 \[many vegetables\]55\], and appropriate portion sizes and variety for healthy growth.
Behavioral: Responsive Feeding Training
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.
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.
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)
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)
| Milestone | Responsive Feeding | Routine Care |
|---|---|---|
| Started | 37 | 34 |
| Completed | 34 | 30 |
| Not completed | 3 | 4 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Withdrawal by subject | 2 | 1 |
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.
| z-score | Responsive Feeding | Routine Care |
|---|---|---|
| Infant Weight-for-Length Z Scores | 0.43 ± 0.15 | 0.12 ± 0.15 |
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.
| Kcal | Responsive Feeding | Routine Care |
|---|---|---|
| Mean Infant Caloric Intake Compared to Estimated Energy Requirements | 120.90 ± 43.37 | 242.06 ± 48.73 |
Collected over From Baseline through Study Completion, an approximate total of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Responsive Feeding | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Routine Care | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Categorical(Participants) | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| <=18 years | 37 | 34 | 71 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(months) | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| Mean | 6.86 ± 1.57 | 7.29 ± 1.64 | 7.07 ± 1.61 |
| Sex: Female, Male(Participants) | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| Female | 15 | 19 | 34 |
| Male | 22 | 15 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 32 | 31 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 9 | 14 |
| White | 23 | 20 | 43 |
| More than one race | 6 | 4 | 10 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Responsive Feeding | Routine Care | Total |
|---|---|---|---|
| United States | 37 | 34 | 71 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill (UNC).
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University of North Carolina, Chapel Hill